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Queguiner Frederic, Kristina Bezirganyan, Sandrine Gensollen, Elise Falek, Laurence Curel, Marie Raffray, Guillaume Penaranda, Maud Righini Chossegros; Elouan Study results. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5382.
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© ARVO (1962-2015); The Authors (2016-present)
Elouan is a retrospective observational single-center study reporting the results of 144 patients (165 eyes) treated for wet age-related macular degeneration (AMD) with ranibizumab over two years. The main objective was to describe the evolution of visual acuity (VA) throughout follow-up (FU) visits. Secondary objectives were to analyze: numbers of FU and intravitreal injections (IVI), time intervals between FU and IVI, and results comparisons within subgroups.
All consecutive patients treated in the ophthalmologic department for wet AMD with ranibizumab and IVI, between August 2011 and August 2013, were included in the study. FU intervals varied according to the two surgeons of the department. All retinal neovessels (NV) types were included. After an initial visit, FU data were analyzed at 3, 6, 12, 18, and 24 months. The results were compared with the literature. Several analyzes were performed on different subgroups: patients undergoing or not a 3-monthly-dose initial treatment, subgroups based on NV type and on follow-up times. Advanced statistical analyses were performed to study VA evolution, based on ETDRS score and Snellen equivalent scale, at each time of follow-up. Non parametric tests, as Wilcoxon or Brown-Mood tests, and parametric tests, as Chi-square or Fisher tests, were used.
Study population: 67.36% women; mean age 78.6 ± 8.2 years; 15 ± 6.6 months mean FU; major medical history: arterial hypertension (54%), dyslipidemia (33%), diabetes (17%). The 1st year, the mean FU number was 9.9 ± 4.8 for a mean IVI number of 6.7 ± 5.6. VA gradually increased up to 6 months and secondarily decreased up to 18 months before stabilizing. The VA difference between initial visit and FU was statistically significant at 6 months for both Snellen equivalent scale (p=0.0009) and ETDRS score (p=0.0069) (fig1). At the end of FU, 44% of patients presented a VA stability, 12% gained more than 3 lines (fig2) and 82% had lost less than 3 lines. There was no significative VA difference in the subgroup with initial treatment.
This unique retrospective observational study, conducted on a large population, confirm the safety and efficacy of ranibizumab in IVI to treat wet AMD. The results showed that the initial NV type did not affect VA evolution, but patients with neo-vascularized retinal pigment epithelium detachment had more IVI. Furthermore, a systematic 3-month initial treatment seemed not useful for all patients.(ClinicalTrials.gov: NCT02089503).
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