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Salomon Y Cohen, Catherine P Garcher, Jean-Francois Korobelnik, Laurent Kodjikian, Ramin Tadayoni, Michel Weber, Martine Mauget-Faysse, Sam Razavi, Joel Uzzan, ingrid Dufour; Real Life of Aflibercept In FraNce: oBservatiOnal study in Wet AMD: the RAINBOW study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4601.
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The Rainbow study was implemented to collect real-life data on 600 patients with naïve wet AMD (wAMD) for whom treatment with aflibercept was initiated as first-line therapy. This large real life study with aflibercept will allow evaluating whether results of the VIEW Studies could be transposable in real-life conditions in France.
Rainbow is a retrospective and prospective observational study of 600 consecutive patients with wAMD included by a sample of 60 investigators selected with respect to activity and geography criteria, representative of French ophthalmologists. Patients have to be treated as part of the routine clinical practice in France. Any decisions on diagnostic and treatment-related procedures have to be made at the discretion of the investigator according to his/her medical practice. Patients will have a 48-month follow-up period during which routine visits will be considered as part of the study.<br /> Recorded data are: demographic data of patients, type of choroidal neovascularization (CNV), tools used for initial diagnosis of CNV, i.e. SD-OCT, and/or fluorescein angiography (FA) and/or indocyanine green angiography (ICGA), changes in ETDRS visual acuity, changes in central retinal thickness (CRT) measured with SD-OCT, number of intravitreal injection performed with aflibercept or with other anti-VEGF agents.
Recruitment is ongoing, with an inclusion rate better than expected. At the time of submission of this abstract, the baseline characteristics showed a mean BCVA of 54.14 ± 17.71 letters, mean CRT of 383.50 ± 122.47 µm. Most patients were female (63.20%), their mean age was 81.27 ± 7.20 years. The tools used for initial diagnosis were SD-OCT (90.91%), FA (74.42%), ICGA (52.5%). Subtypes of CNV were: classic or minimally classic (37.50%), occult (20.83%), RAP (12.50%). Given retrospective/prospective study design, 3-and 6-month results should be available for most patients in April 2015.
Data collected in the real life are important to be compared with results of randomized clinical trials. The Rainbow study will be the first observational study to analyze results of aflibercept used in the real-life as first-line therapy in naïve wAMD in France. Results will also provide information on the practices for the monitoring and re-treatment strategy with aflibercept.<br /> <br /> Clinical Trials.gov Identifier: NCT02279537, First Received: October 29, 2014
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