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SIMON patrick; Non-interventional retrospective study to evaluate efficacy of the treatment with anti-VEGF (Aflibercept) in naive and non-naive patients with an Pigmentary epithelial detachment secondary to age-related macular degeneration.. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4603.
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A retrospective non interventional study was initiated in France, within 5 centers to describe<br /> evolution of fluid in naïve and non-naïve patients with an exudative retinal pigment epithelium<br /> detachment secondary to age related macular degeneration have been included.<br /> The follow-up period was 28 weeks after initiation of treatment with aflibercept.
50 patients have been included included in 5 different centers. Age of patients ≥ 50 years old. All of them ,presenting an exsudative detachment of the retinal pigment epithelium secondary to age related macular degeneration with sub-retinal fluid or a macular oedema. Classification of patients in this study was,: naïve patient innocent of any treatment (25 patients) or non- naïve patients ( 25 patients) of treatment by anti-VEGF. All non-naïve patients must have received at least 6 intra-vitreal injections of Ranibizumab during the last 12 months prior inclusion. The data of 50 patients have been collected and allow to estimate a 50 % proportion with a 14 % precision is a bilateral reliable interval of 95 % [36 64 %]. We analyse visual acuity, evolution of macular oedema, epithelial pigment detachment, central thickness of macula.The statistical analysis will be descriptive.
The main objective of the study was to describe evolution of the sub-retinal fluid at the end of 28 weeks versus baselineafter treatment with Aflibercept in naive and non-naive patients. 80 % of patients presented a decrease of fluid after 28 weeks of treatment with Aflibercept in both group naive and non-naive patients.Regarding secondary outcome the macular oedema disappeared in 80 % of patients 28 weeks after initiation of the treatment with Aflibercept. Evolution of the best visual acuity corrected was 15 letters at 28 weeks versus baseline in naive and non-naive patients. 50 % reduction of the maximal height of the pigment epithelial detachment at 28 weeks versus baseline.
These results in patients with age macular degeneration demonstrate significant impact of Aflibercept on anatomic and functional parameters. Additional studies including more patients and conducted prospectively should be performed to complete these results.
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