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Clinical course of patients with exudative-haemorrhagic age-related macular degeneration treated with ranibizumab. Eye2Eye study
Evolución clínica de pacientes con degeneración macular asociada a la edad de tipo exudativo-hemorrágico tratados con ranibizumab. Estudio Eye2Eye
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Datos ausentes (n) a los 12 meses: drusas (16), hemorragia (15), exudado lipídico (16), desprendimiento EPR (15), atrofia (19), fibrosis (17).</p> <p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Grupo 2. Datos ausentes (n) basales: drusas (3), hemorragia (2), exudado lipídico (4), desprendimiento EPR (5), atrofia (7), fibrosis (9). Datos ausentes (n) a los 12 meses: drusas (19), hemorragia (19), exudado lipídico (21), desprendimiento EPR (22), atrofia (22), fibrosis (23).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "J. Araiz, I. Fernández-Baca, M. Roura" "autores" => array:4 [ 0 => array:2 [ "nombre" => "J." "apellidos" => "Araiz" ] 1 => array:2 [ "nombre" => "I." "apellidos" => "Fernández-Baca" ] 2 => array:2 [ "nombre" => "M." 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Threshold points 1–9. Perimetric correlation maps obtained by calculating Pearson's correlation coefficient (<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>0.65. <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001). Red: evaluated points. Dark green: point with the highest correlation with the evaluated point. Light green: rest of points within the same hemifield with a correlation of <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>0.65.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "N. Güerri, V. Polo, J.M. Larrosa, C. Egea, A. Ferreras, L.E. Pablo" "autores" => array:6 [ 0 => array:2 [ "nombre" => "N." "apellidos" => "Güerri" ] 1 => array:2 [ "nombre" => "V." 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Eye2Eye study" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "216" "paginaFinal" => "222" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "J. Araiz, I. Fernández-Baca, M. Roura" "autores" => array:4 [ 0 => array:4 [ "nombre" => "J." "apellidos" => "Araiz" "email" => array:1 [ 0 => "araiz@icqo.org" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">¿</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "I." "apellidos" => "Fernández-Baca" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "M." "apellidos" => "Roura" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:2 [ "colaborador" => "on behalf of the Study Group EYE2EYE" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">◊</span>" "identificador" => "fn0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Servicio de Oftalmología, Hospital San Eloy, Barakaldo, Vizcaya, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Oftalmología, Hospital Regional Universitario Carlos Haya, Málaga, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Departamento médico, Novartis Farmacéutica, S.A., Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "<span class="elsevierStyleItalic">Corresponding author</span>." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Evolución clínica de pacientes con degeneración macular asociada a la edad de tipo exudativo-hemorrágico tratados con ranibizumab. Estudio Eye2Eye" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1907 "Ancho" => 1631 "Tamanyo" => 157501 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Retinal lesions (ocular fundus). Group 1. Baseline missing data (n): drusen (3), hemorrhage (4), lipidic exudate (9), RPE detachment (6), atrophy (11), fibrosis (13). Missing data (n) at 12 months: drusen (16), hemorrhage (15), lipidic exudate (16), RPE detachment (15), atrophy (19), fibrosis (17). Group 2. Baseline missing data (n): drusen (3), hemorrhage (2), lipidic exudate (4), RPE detachment (5), atrophy (7), fibrosis (9). Missing data (n) at 12 months: drusen (19), hemorrhage (19), lipidic exudate (21), RPE detachment (22), atrophy (22), fibrosis (23).</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Age-related macular degeneration (ARMD) is the most frequent cause of severe and irreversible visual acuity (VA) loss in people over 60 in developed countries. In Europe, 1.7% of adults over 55 are affected.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> The most severe form of the disease is exudative-hemorrhagic ARMD (EH-ARMD) which accounts for 10–15% of the disease and is the cause of the highest percentage of irreversible blindness.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Among the pharmacological therapeutic options for treating EH-ARMD, vascular endothelial growth factor A (VEGF-A) inhibition is an efficient and first choice strategy for treating patients with this disease.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Ranibizumab is a humanized monoclonal antibody fragment that neutralizes all the biologically active isoforms of VEGF-A.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5,6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Available experience on ARMD evidences that, when it affects the first eye the patient detects the onset of the disease at a later stage because the second eye maintains normal VA and compensates the visual deficit caused by the first eye. Accordingly, when the patient begins treatment for the first affected eye, the disease is generally at a more advanced stage. When the disease progresses and involves the second eye the patient detects symptoms earlier and therefore can receive treatment at an early stage. Early diagnosis and treatment is important to preserve useful central vision and diminish the risk of blindness in patients with ARMD.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The instant study has carried out a retrospective analysis of the use of ranibizumab in 2 clinical situations of EH-ARMD: (a) the first eye affected, (b) the second eye affected having exhibited neovascular ARMD in the first eye. The main objective of the study was to assess the mean change of the best corrected visual acuity (BCVA) in 2 groups of patients with EH-ARMD treated with ranibizumab: (a) patients with one affected eye and (b) patients with the second eye affected, having the first eye already involved. In addition, it also assessed the clinical evolution of the 2 groups of patients on the basis of the retinal lesions, establishing the risk factors associated to ARMD and assessing the frequency of intravitreal injections in the course of the study.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><p id="par0025" class="elsevierStylePara elsevierViewall">An observational, retrospective, multicenter and national study was carried out with patients affected by EH-ARMD and treated with intravitreal ranibizumab for at least 12 months. Clinical history records of the patients were taken in the period comprised between February and November 2009.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The patients were distributed in 2 groups: those with the first eye affected (group 1) and patients with the second eye affected having the first eye already involved (group 2).</p><p id="par0035" class="elsevierStylePara elsevierViewall">The study protocol was approved by the Ethics Committee of the Cruces Hospital and all participants signed an informed consent. The principles of the Helsinki declaration were followed.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The study included patients aged 50 years or over diagnosed with active or recurrent subfoveal choroidal neovascularization (CNV) secondary to EH-ARMD having BCVA data (determined by ETDRS optotypes and, if these data were not available, Snellen optotypes data were converted to ETDRS) as minimum data prior to beginning treatment with ranibizumab (Lucentis<span class="elsevierStyleSup">®</span>) (baseline data) and after 12 months of treatment. The study excluded patients who had received other systemic or ocular anti-VEGF agents concomitantly, previous treatments in the eye of the study with external radiotherapy, vitrectomy of trans-pupil thermotherapy, as well as patients with ocular disorders which could lead to confusion in the interpretation of results (retina detachment or macular hole, active intraocular inflammation [grade: traces or above] or persistent macular edema due to uveitis or other inflammatory diseases).</p><p id="par0045" class="elsevierStylePara elsevierViewall">Assessments comprised clinical symptoms, BCVA, optic coherence tomography (OCT) (Zeiss Humphrey system OCT™ 3 version A6.1 or more recent), ocular fundus and angiograph, collecting available clinical record data of the patient in each of the 13 visits in the 12 months after beginning treatment with ranibizumab. The foveal thickness was measured establishing the mean foveal thickness. The effect of the treatment was followed on the basis of BCVA.</p><p id="par0050" class="elsevierStylePara elsevierViewall">The dose was assessed considering the date of the first injection of ranibizumab, the date of reinjection at 30<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>15 days from the first injection and the date of reinjection 60<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>15 days after the first injection of ranibizumab.</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Statistical analysis</span><p id="par0055" class="elsevierStylePara elsevierViewall">Categorical variables were described by absolute and relative frequencies, including a confidence interval of 95%. Mean, typical deviation and average were utilized for describing continuous variables, including the overall number of valid values.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Variable comparison tests were utilized between groups 1 and 2 according to the nature thereof. Parametric tests were used for quantitative variables (t for Student or ANOVA) or nonparametric (Mann–Whitney or Kruskal–Wallis), according to the characteristics of the study variables. Categorical variables were assessed with the Chi square test. <span class="elsevierStyleItalic">P</span> values below 0.05 were taken as significant. All the statistical analyses were carried out utilizing SAS<span class="elsevierStyleSup">®</span> System for Windows version 9.1.3 (SAS Institute, Cary, NC, USA).</p></span></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Results</span><p id="par0065" class="elsevierStylePara elsevierViewall">The study involved the participation of 59 researchers and 184 patients (184 eyes: 91 of group 1 and 93 of group 2).</p><p id="par0070" class="elsevierStylePara elsevierViewall">The mean age of patients included in the study was 75 years (53.6% females and 46.4% males). The demographic characteristics and baseline symptoms of the patients are detailed in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0075" class="elsevierStylePara elsevierViewall">The BCVA results exhibited significant VA improvement at month 12 of treatment vs baseline data in both groups (53.2<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>21.6 vs 43.9<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>21.4 letters in group 1. <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001 and 52.9<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>19.9 vs 47.7<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>18.4 letters in group 2, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.0042). The mean BCVA change was of 9.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>18.0 letters in group 1 and 5.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.8 letters in group 2, observing a nonsignificant trend toward greater improvement in group 1 (CI 95% 5.6–13.0) vs group 2 (CI 95% 1.7–8.5) (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.0789).</p><p id="par0080" class="elsevierStylePara elsevierViewall">VA improvement (taken as a gain of ≥15 letters) after 12 months of treatment was 38.5% (CI 95%, 28.5–48.5) in group 1 and 26.9% in group 2 (CI 95%, 17.9–35.9), observing a trend toward greater improvement in group 1 vs group 2 (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.0939).</p><p id="par0085" class="elsevierStylePara elsevierViewall">In what concerns changes in ocular fundus examinations (baseline visits against treatment month 12) related to drusen, a reduction in the presence of soft drusen was observed, particularly in group 2, which diminished from 70.2% to 59.5%. In group 1, the reduction was of 68.9–60.0%. In addition, group 2 exhibited a reduction of confluent soft drusen from 64.1% to 54.2%. In contrast with group 2, in group 1 confluent soft drusen remained in the area of 70%. Retinal injuries in the overall population (baseline vs 12 months) were: drusen (69.1 vs 61.1%), macular hemorrhage (59.0 vs 7.3%), lipidic exudates (28.1 vs 8.2%) and pigment epithelium detachment (46.8 vs 19.0%), without observing significant differences in any of said retinal injuries between both groups. <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> details the percentages of retinal injuries for each group of the study.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0090" class="elsevierStylePara elsevierViewall">The mean size of the neovascular membrane at the baseline visits, assessed by means of fluorescein angiography, was of 1.8<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.1 and 1.9<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.1 disk areas, in group 1 and group 2 respectively. CNV location was subfoveal in both groups in 70.0% of cases and juxtafoveal in the rest. In what concerns the angiographic characterization of membrane type, group 1 exhibited the same percentage of classic and hidden membranes (28.0%), whereas in group 2 hidden membranes were more frequent than classic ones (37.8 vs 24.3%). Angiographic results at treatment month 12 could not be assessed due to the high number of lost values.</p><p id="par0095" class="elsevierStylePara elsevierViewall">OCT results in the overall population (baseline vs 12 months) exhibited a reduction of macular edema (73.6 vs 20.9%), retina serous detachment (71.3 vs 14.7%) and intraretinal cysts (38.5 vs 19.7%), without observing significant differences between the groups. <a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a> describes the results of OCT for each study group. Changes were also observed for the mean foveal thickness, which diminished from 377.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>109.8<span class="elsevierStyleHsp" style=""></span>μm to 249.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>67.8<span class="elsevierStyleHsp" style=""></span>μm in group 1 and from 354.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>123.2<span class="elsevierStyleHsp" style=""></span>μm to 254.6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>67.4<span class="elsevierStyleHsp" style=""></span>μm in group 2, with <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001 in both groups, without observing significant differences between groups.</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0100" class="elsevierStylePara elsevierViewall">The most predominant risk factors for EH-ARMD in the overall population were arterial hypertension (AHT), being female (53.6%) and exposure to ultraviolet rays (40.5%). <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> illustrates the risk factors for each group of the study. Significant differences between the groups were not observed with the exception of obesity which was of 23.9% in group 2 vs 11.5% in group 1 (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.0321).</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">The administration of ranibizumab after the first dose was carried out mainly between the first and second months (visit 2 [87.9% group 1 and 80.7% group 2] and visit 3 [72.5% group 1 and 62.4% group 2], respectively) (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>). The time elapsed between the first and second dose was of 5.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.8 weeks in group 1 and 6.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>6.2 in group 2, although these differences were not statistically significant. However, said waiting periods increased in subsequent re-injections: between the third and fourth dose the intervals were 15.8<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>10.8 and 12.9<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>10.2 weeks, respectively. No significant differences were observed in the intervals between both groups of patients. The mean number of ranibizumab injections was of 4.8<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.8 injections per year in both groups. In 59.2% of patients, the charge dose of ranibizumab was correct (64.8% group 1 and 53.8% group 2), without observing statistically significant differences between both.</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Discussion</span><p id="par0110" class="elsevierStylePara elsevierViewall">It has been demonstrated that VEGF contributes to the development and proliferation of CNV secondary to ARMD.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> The application of ranibizumab in this indication has been assessed in numerous clinical trials and series of patients, ranging from initial studies comparing its efficacy against photodynamic treatment<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> to publications describing a single case of a patient with multifocal choroiditis<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> who exhibited a positive response after 5 intravitreal injections. In the instant study the anatomic and visual improvement experienced by CNV patients after the administration of intravitreal ranibizumab is evident, both in group 1 as in group 2. Specifically, the ocular fundus examination results demonstrated a significant reduction in the percentage of retinal lesions, particularly hemorrhages as well as drusen, lipidic exudates, retina pigment epithelium detachment and intraretinal cysts in addition to reducing the mean foveal thickness, diminishing the presence of macular edema, the size of neovascular membranes and serous retina detachments in both groups. However, increased atrophy and fibrosis were also observed.</p><p id="par0115" class="elsevierStylePara elsevierViewall">A previous study by Eldaly et al.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> comparing the evolution of ARMD in patients with a first eye involved against the second eye demonstrated that patients with the first eye involved exhibited significant lower baseline VA against patients with the second eye involved (0.86 vs 0.44 as per the LogMar optotype). In the present study group 1 patients also exhibited lower baseline VA in comparison with patients with the second eye involved although these differences were not significant.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> These data match expectations as it is assumed that patients with one eye involved will take longer to perceive the onset of the disease because the second eye offsets the visual defects and therefore when the disease is identified it is more advanced.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">The results of the present work after 12 months of treatment exhibited similar VA values in both groups of patients, observing a tendency toward a greater mean change in the VA of patients with the first eye involved against the second eye involved, even though this tendency is not significant. The study published by Eldaly et al.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> reported that patients with one affected eye as well as those with both affected eyes exhibited similar results in terms of increased letters after 3 months of ranibizumab treatment. Said authors observed that about half of patients, both those exhibiting the first eye involved as well as the second eye involved, exhibited a significant VA improvement (≥gain of 15 letters). The data presented in this study report lower VA improvement of 32.6% in the overall population, evidencing a nonsignificant tendency toward greater improvement in group 1 patients (38.5 vs 26.9%).</p><p id="par0125" class="elsevierStylePara elsevierViewall">On the other hand, the increased atrophy rates observed after treatment with ranibizumab described in our series have been reported previously. In the conclusions of a study on 78 eyes treated with ranibizumab with or without photodynamic treatment, Rishi et al.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> reported a minimum amount of eyes coursing with atrophy (2/78). Accordingly, this effect should be taken into account before beginning the treatment.</p><p id="par0130" class="elsevierStylePara elsevierViewall">The interpretation of results and the generalization thereof should be approached cautiously due to the limitations of the study. The main limitation lies in the sample selection bias because, even though it is taken from multiple centers, non-probabilistic sampling does not make sure that the population of the study is representative. In addition, the retrospective design of the study predisposes toward an increase of lost values for the study variables. A further limitation is the lack of a selection of treatment guidelines applied in each center, which would allow a more balanced comparison between the 2 groups of patients and could interfere in the interpretation of results in the short and long term. The strong points of the study include an optimum cohort follow-up to analyze the dynamic and progressive effects of the treatment. In addition, the location of the centers that took part in the study provides an adequate geographical coverage of the population. Likewise, the degree of compliance of inclusion criteria between the patients of the study was very high in both groups (77.1% in group 1 and 80.9% in group 2).</p><p id="par0135" class="elsevierStylePara elsevierViewall">Even though the previous working hypotheses of the instant study postulated high-yield VA gains in the first stages of the treatment, the results demonstrate VA gains in both groups of patients without significant differences between them. By way of conclusion, ranibizumab exhibits good effectiveness in the treatment of EH-ARMD in clinical practice in both groups of patients as the intravitreal administration of ranibizumab during 12 months at least improved VA in patients with CNV secondary to EH-ARMD both with the first affected eye as well as the second affected eye.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Funding</span><p id="par0140" class="elsevierStylePara elsevierViewall">Financial and material support for this research was provided by Novartis Farmacéutica S.A.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Conflict of interests</span><p id="par0145" class="elsevierStylePara elsevierViewall">M. Roura is in the employment of Novartis Farmacéutica S.A.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:2 [ "identificador" => "xres273619" "titulo" => array:5 [ 0 => "Abstract" 1 => "Objective" 2 => "Methods" 3 => "Results" 4 => "Conclusions" ] ] 1 => array:2 [ "identificador" => "xpalclavsec255621" "titulo" => "Keywords" ] 2 => array:2 [ "identificador" => "xres273618" "titulo" => array:5 [ 0 => "Resumen" 1 => "Objetivo" 2 => "Métodos" 3 => "Resultados" 4 => "Conclusiones" ] ] 3 => array:2 [ "identificador" => "xpalclavsec255622" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Materials and methods" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Statistical analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0020" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0025" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0030" "titulo" => "Funding" ] 9 => array:2 [ "identificador" => "sec0035" "titulo" => "Conflict of interests" ] 10 => array:2 [ "identificador" => "xack62606" "titulo" => "Acknowledgments" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2012-02-03" "fechaAceptado" => "2012-07-02" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec255621" "palabras" => array:6 [ 0 => "Age-related macular degeneration" 1 => "Ranibizumab" 2 => "Choroidal neovascularisation" 3 => "Visual acuity" 4 => "Optical coherence tomography" 5 => "Angiography" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec255622" "palabras" => array:6 [ 0 => "Degeneración macular asociada a la edad" 1 => "Ranibizumab" 2 => "Neovascularización coroidea" 3 => "Agudeza visual" 4 => "Tomografía de coherencia óptica" 5 => "Angiografía" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To assess the mean best-corrected visual acuity (BCVA) change in patients with exudative-hemorrhagic age-related macular degeneration (EH-ARMD) after 12-month period of treatment with ranibizumab.</p> <span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A retrospective, multicentre and national study of intravitreal administered ranibizumab was conducted on two groups of EH-ARMD patients: only one eye affected (group 1) vs second eye affected (group 2), having the first one affected.</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Eligible subjects were ≥50 years old with primary or secondary active subfoveal EH-ARMD-related choroidal neovascularisation (CNV).</p> <span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">A total of 184 patients (91 group 1 and 93 group 2) were included. Mean age (SD) was 75.3 (7.5) years, and 53.6% were women. The BCVA showed a VA improvement at 12 months of 9.3 (18.0) number of letters in group 1 and 5.1 (16.8) number of letters in group 2 (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001 and <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.0042, respectively). No statistical differences between groups were observed. Lesion characteristics in the total population (baseline vs 12-month) were: drusen (69.1% vs 61.1%), macular hemorrhages (59.0% vs 7.3%), lipid exudates (28.1% vs 8.2%), and retinal pigment epithelium detachment (46.8% vs 19.0%). The optical coherence tomography (OCT) in the total population (baseline vs 12-month) showed a reduction in macular edema (73.6% vs 20.9%), subretinal fluids (71.3% vs 14.7%), and intraretinal cysts (38.5% vs 19.7%), as well as a reduction of the mean foveal thickness 377.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>109.8<span class="elsevierStyleHsp" style=""></span>μm vs 249.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>67.8<span class="elsevierStyleHsp" style=""></span>μm in group 1 and 354.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>123.2<span class="elsevierStyleHsp" style=""></span>μm vs 254.6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>67.4<span class="elsevierStyleHsp" style=""></span>μm in group 2, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001, both groups, with no significant differences between groups.</p> <span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Intravitreal administration of ranibizumab for a minimum of 12-months significantly improved the BCVA, decreased lesion characteristics, and reduced the initial mean foveal thickness in patients with CNV primary or secondary to EH-ARMD, both in patients with only one eye affected and in patients with a second eye affected, having the first one affected.</p>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Evaluar el cambio medio de la mejor agudeza visual corregida (MAVC) en pacientes con DMAE exudativa-hemorrágica (DMAE-EH) a los 12-meses de tratamiento con ranibizumab.</p> <span class="elsevierStyleSectionTitle" id="sect0040">Métodos</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Estudio observacional, retrospectivo, multicéntrico y nacional, en dos grupos de pacientes con DMAE-EH: primer ojo afectado (grupo 1) y segundo ojo afectado (grupo 2), teniendo afectado el primer ojo.</p><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron pacientes ≥50 años, diagnosticados de neovascularización coroidea subfoveal activa principal o recurrente secundaria a DMAE-EH.</p> <span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 184 pacientes (91 grupo 1 y 93 grupo 2), edad media<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>DE de 75,3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>7,5 años y 53,6% mujeres. La MAVC mostró una mejoría de la AV a los 12-meses: 9,3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>18,0 número de letras grupo 1 y 5,1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16,8 número de letras grupo 2 (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0,0001 y <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,0042, respectivamente), sin observarse diferencias significativas (NS) entre ambos grupos. Las lesiones retinianas en la población total (basal vs 12-meses) fueron: drusas (69,1% vs 61,1%), hemorragias maculares (59,0% vs 7,3%), exudados lipídicos (28,1% vs 8,2%) y desprendimiento del epitelio pigmentario (46,8% vs 19,0%). Los resultados de la OCT en la población total (basal vs 12-meses) mostraron una reducción del edema macular (73,6% vs 20,9%), del fluido subrretiniano (71,3% vs 14,7%) y de quistes intrarretinianos (38,5% vs 19,7%), así como una reducción del grosor foveal medio de 377,4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>109,8<span class="elsevierStyleHsp" style=""></span>μm vs 249,1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>67,8<span class="elsevierStyleHsp" style=""></span>μm grupo 1 y 354,1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>123,2<span class="elsevierStyleHsp" style=""></span>μm vs 254,6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>67,4<span class="elsevierStyleHsp" style=""></span>μm grupo 2, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0,0001, ambos grupos, sin observarse diferencias significativas entre ambos grupos.</p> <span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">La administración de ranibizumab intravítreo durante un mínimo de 12-meses conllevó una mejoría significativa en la MAVC, una disminución de las lesiones retinianas y una disminución del grosor retiniano medio inicial en pacientes con NVC principal o secundaria a DMAE E-H, tanto en los pacientes con primer ojo afectado como en los pacientes con segundo ojo afectado, teniendo afectado el primero.</p>" ] ] "NotaPie" => array:3 [ 0 => array:2 [ "etiqueta" => "◊" "nota" => "<p class="elsevierStyleNotepara" id="npar0030">The co-authors of the study are presented Eye2Eye in <a class="elsevierStyleCrossRef" href="#sec0040">Annex 1</a>.</p>" ] 1 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Please cite this article as: Araiz J, et al. Evolución clínica de pacientes con degeneración macular asociada a la edad de tipo exudativo-hemorrágico tratados con ranibizumab. Estudio Eye2Eye. Arch Soc Esp Oftalmol. 2013;88:216–22.</p>" ] 2 => array:2 [ "etiqueta" => "☆☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0025">The results of this work have been presented at the congress of the Spanish Society of Retina and Vitreous and Euretina 11th Congress.</p>" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:3 [ "apendice" => "<p id="par0155" class="elsevierStylePara elsevierViewall">Abengoechea Hernández, S; Abreu González, R; Aguayo Canela, A; Alarcon Valero, I; Aliseda Pérez, D; Arias Barquet, L; Artaraz Beobide, JI; Baget Bernaldiz, M; Barbarias Salinas, MG; Basauri Rementeria, E; Burdeus Gómez, R; Cabrera López, F; Calvo González, C; Casado Martín, J; Castillo López, E; Cava Valenciano, C; Cervera Taulet, E; Coco Martín, RM; Criado del Hoyo, D; Delgado Alonso, E; Desco Esteban, MC; Donate López, J; Escobar Barranco, JJ; Esteban González, E; Faus Guijarro, F; Fernández Rodríguez, MI; Gallego Pinazo, R; Fernández-Baca, G; García Torre, M; González-Costea López, A; Guiote Linares, JR; Lorenzo Soto, M; Macías Molinero, L; Martín Gil del Corral, A; Mataix Boronat, J; Méndez Vázquez, C; Mendivil Soto, MP; Monés Carilla, J; Mora Castilla, J; Mora García, J; Morillo Sánchez, MJ; Olea Vallejo, JL; Pazos González, MCB; Piñuel González, JA; Pons Crespi, M; Reyes Rodríguez, MA; Rodríguez Villace, C; Romero Aroca, P; Roque Meseguer, A; Sanabria Ruiz, MR; Sánchez de Antonio, PA; Sánchez-Waisen Haez, F; Santos Lacomba, M; Serrano de la Iglesia, J; Serrano García, MA; Poposlki, V; Toribio García, M; Torron Fernández, C; Valdés Sanz, N.</p>" "etiqueta" => "Annex 1" "identificador" => "sec0040" ] ] ] ] "multimedia" => array:5 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1907 "Ancho" => 1631 "Tamanyo" => 157501 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Retinal lesions (ocular fundus). Group 1. Baseline missing data (n): drusen (3), hemorrhage (4), lipidic exudate (9), RPE detachment (6), atrophy (11), fibrosis (13). Missing data (n) at 12 months: drusen (16), hemorrhage (15), lipidic exudate (16), RPE detachment (15), atrophy (19), fibrosis (17). Group 2. Baseline missing data (n): drusen (3), hemorrhage (2), lipidic exudate (4), RPE detachment (5), atrophy (7), fibrosis (9). Missing data (n) at 12 months: drusen (19), hemorrhage (19), lipidic exudate (21), RPE detachment (22), atrophy (22), fibrosis (23).</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1870 "Ancho" => 1620 "Tamanyo" => 133617 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Retinal lesions (OCT). Group 1. Baseline missing data (n): macular edema (19), serous retinal detachment (21), intraretinal cysts (19). Missing data (n) at 12 months: macular edema (25), serous retinal detachment (25), intraretinal cysts (27). Group 2. Baseline missing data (n): macular edema (21), serous retinal detachment (20), intraretinal cysts (22). Missing data (n) at 12 months: macular edema (30), serous retinal detachment (30), intraretinal cysts (30).</p>" ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Fig. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1151 "Ancho" => 2374 "Tamanyo" => 145146 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Number of intravitreal injections during the study.</p>" ] ] 3 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:3 [ "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">SD, standard deviation.</p><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Missing data (n), by: age (2 group 1; 1 group 2), sex (3 group 1; 2 group 2), metamorphopsia (7 group 1; 17 group 2), alteration of colors (15 group 1; 22 group 2), Central scotoma (8 group 1; 13 group 2), previous treatments (1 group 1).</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Group 1 n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>91 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Group 2 n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>93 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Total n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>184 \t\t\t\t\t\t\n \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Age (years), mean</span><span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleBold">SD</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">74.5<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>7.7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">76.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>7.2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">75.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>7.5 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Female, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 (54.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 (52.7) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">96 (53.6) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Metamorphopsia, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">64 (76.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">61 (80.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">125 (78.1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Alteration of colors, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26 (34.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 (33.8) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">50 (34.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Central scotoma, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">69 (83.1) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">57 (71.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">126 (77.3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">No previous treatment, n (%)</span><a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">75 (82.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">60 (64.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">135 (73.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="4" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="4" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Types of previous treatments</span><a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a>, <span class="elsevierStyleBold">n (%)</span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Laser photocoagulation</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (0.0) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (2.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Photodinamyc therapy with verteporfin</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 (8.8) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 (12.9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">20 (10.9) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Triamcinolone acetonide</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (0.0) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 (5.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 (2.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="4" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Antiangiogenics, typestipos</span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>Sodium pegaptanib \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (0.0) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 (5.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 (2.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>Bevacizumab \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (3.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 (7.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 (5.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="4" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleBold">Others, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (4.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (4.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 (4.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab392966.png" ] ] ] "notaPie" => array:2 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "<p class="elsevierStyleNotepara" id="npar0005"><span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.0178.</p>" ] 1 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "b" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">One patient could have received more than one previous treatment.</p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Baseline demographic and clinical data.</p>" ] ] 4 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:3 [ "leyenda" => "<p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">UV: ultraviolet.</p><p id="spar0095" class="elsevierStyleSimplePara elsevierViewall">Missing data (n), by: AHT (1), sex (5 exposure), UV (11), alterations CV (17), obesity (9), MD (4), family history (17), tobacco (4).</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">n (%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Group 1 n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>91 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Group 2 n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>93 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Total n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>184 \t\t\t\t\t\t\n \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Arterial hypertension \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">59 (64.8) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">62 (67.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">121 (66.1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Sex (female) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 (54.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 (52.7) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">96 (53.6) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Excessive exposure to UV light \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">36 (41.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">34 (39.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">70 (40.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Cardiovascular alterations \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23 (29.1) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">31 (35.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">54 (32.3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Obesity<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 (11.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">21 (23.9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">31 (17.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Diabetes mellitus \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 (13.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 (13.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 (13.3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Family history \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">10 (11.9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11 (13.3) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">21 (12.6) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Tobacco \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 (15.9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 (7.6) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">21 (11.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab392967.png" ] ] ] 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| Year/Month | Html | Total | |
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| 2023 March | 1 | 0 | 1 |
| 2018 February | 14 | 0 | 14 |
| 2018 January | 12 | 0 | 12 |
| 2017 December | 17 | 3 | 20 |
| 2017 November | 15 | 1 | 16 |
| 2017 October | 14 | 1 | 15 |
| 2017 September | 11 | 1 | 12 |
| 2017 August | 7 | 1 | 8 |
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| 2017 June | 27 | 8 | 35 |
| 2017 May | 26 | 0 | 26 |
| 2017 April | 19 | 1 | 20 |
| 2017 March | 12 | 1 | 13 |
| 2017 February | 27 | 5 | 32 |
| 2017 January | 26 | 0 | 26 |
| 2016 December | 28 | 2 | 30 |
| 2016 November | 19 | 6 | 25 |
| 2016 October | 45 | 3 | 48 |
| 2016 September | 20 | 2 | 22 |
| 2016 August | 21 | 4 | 25 |
| 2016 July | 16 | 1 | 17 |
| 2016 June | 18 | 4 | 22 |
| 2016 May | 12 | 5 | 17 |
| 2016 April | 14 | 6 | 20 |
| 2016 March | 13 | 13 | 26 |
| 2016 February | 13 | 10 | 23 |
| 2016 January | 14 | 11 | 25 |
| 2015 December | 20 | 12 | 32 |
| 2015 November | 12 | 11 | 23 |
| 2015 October | 21 | 12 | 33 |
| 2015 September | 19 | 5 | 24 |
| 2015 August | 15 | 9 | 24 |
| 2015 July | 24 | 2 | 26 |
| 2015 June | 4 | 1 | 5 |
| 2015 May | 16 | 3 | 19 |
| 2015 April | 20 | 9 | 29 |
| 2015 March | 17 | 6 | 23 |
| 2015 February | 15 | 1 | 16 |
| 2015 January | 21 | 2 | 23 |
| 2014 December | 35 | 9 | 44 |
| 2014 November | 34 | 7 | 41 |
| 2014 October | 45 | 6 | 51 |
| 2014 September | 44 | 10 | 54 |
| 2014 August | 33 | 4 | 37 |
| 2014 July | 41 | 5 | 46 |
| 2014 June | 31 | 3 | 34 |
| 2014 May | 30 | 6 | 36 |
| 2014 April | 26 | 2 | 28 |
| 2014 March | 17 | 6 | 23 |
| 2014 February | 21 | 5 | 26 |
| 2014 January | 17 | 4 | 21 |
| 2013 December | 27 | 5 | 32 |
| 2013 November | 1 | 1 | 2 |
Show all
