Real Life Use of Aflibercept In FraNce: oBservatiOnal study in Wet AMD: the RAINBOW study

Abstract

Purpose : To report interim outcomes of patients having completed one year in the RAINBOW study, aiming to collect efficacy and safety data from real-life clinical practice on naïve wet Age-related Macular Degeneration (wAMD) patients treated with intravitreal aflibercept in France.

Methods : RAINBOW is an observational retrospective and prospective study initiated in January 2014 in France, aiming to enroll 600 patients over 4 years. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA), measured using the ETDRS chart from baseline to 12 months. The worst eye of each patient was considered as study eye, but the second eye could also be considered for the study if treatment-naïve. A preliminary analysis was performed on 92 eyes from 84 patients having completed 1 year of follow-up (Full Analysis Set, comprising all patients/eyes having received at least one injection).

Results : The baseline BCVA is summarized in table 1. The primary endpoint results are summarized in table 2. The mean (± SD) number of injections at 12 months was 7.2 (±2.6) in the eyes. Two patients (2.4%) experienced one serious adverse event each, one of which (stroke) was treatment-related, while the other (pneumonia) was not.

Conclusions : The interim analysis of the RAINBOW study showed significant BCVA gains at 12 months (5.9 letters with an average of 7.2 injections) in wAMD naïve patients treated under real-life conditions. No new safety signals were detected.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.