[05/05/2017] the RAINBOW Study Etude observationnelle évaluant l’utilisation de l’Aflibercept en pratique courante en France pour le traitement de la forme humide de la DMLA
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INTRODUCTION: Obtaining real-life evidence is important for ophthalmologists, as the outcomes achieved in randomised studies of anti-vascular endothelial growth factor (VEGF) agents may not always translate into clinical practices. There is also a lack of country-level and real-life evidence in previously naïve patients. The aim of the ongoing RAINBOW study is to monitor the efficacy and safety of intravitreal aflibercept (IVT-AFL) in treatment-naïve patients with wet age-related macular degeneration (wAMD) in clinical practices in France. We report the updated 12-month interim outcomes from this study.
MATERIALS AND METHODS: RAINBOW is an ongoing, observational, retrospective, prospective 4-year study. It is being conducted in 55 centres across France. The study includes 593 patients who received their first IVT-AFL injection between January 2014 and March 2015, and patients will be followed over 4 years. All patients are naïve to any anti-VEGF agent or macular laser. The worst eye of each patient is considered the study eye, but the second eye may also be considered for the study if it is treatment-naïve.
The primary endpoint is the mean change in best-corrected visual acuity (BCVA), Early Treatment Diabetic Retinopathy Study letters from baseline to 12 months. Other endpoints include the proportion of patients who gained ≥15 letters, mean change in central retinal thickness (CRT), and safety at 12 months.
RESULTS: A preliminary analysis was performed on 196 patients (full analysis set) who completed 12 months of follow-up and received at least 1 injection. The mean (SD) age was 78.8 (7.7) years, 62.8% were female, the mean (SD) BCVA was 57.7 (18.3) letters, and mean (SD) CRT was 390.1 (120.2) µm at baseline. The mean (SD) number of injections over 12 months was 6.3 (2.0), and 91.0% of patients received the first 3 injections within the first 120 days (loading phase). The mean (SD) change in BCVA was 6.2 (16.8) letters (all patients) and 7.4 (15.8) letters (patients who received a loading phase) at Month 12. The percentage of patients who gained ≥15 letters was 25.0% at Month 12. The percentage of patients with BCVA ≥20/40 was 32.1% at baseline and 47.4% at Month 12. The mean (SD) reduction in CRT was –107.7 (121.2) µm at Month 12. Fifty one (26.0%) patients experienced at least 1 adverse event (AE), 2.6% experienced treatment-emergent AEs, and 8.7% experienced at least 1 treatment-emergent serious AE; the most common were hospitalisation due to pneumonia/cancer (n=10), hospitalisation due to disorientation (n=2), sudden death (n=1), transient ischaemic attack (n=1), and cardiac disorders (n=3) (none were treatment related).
DISCUSSION: This interim 12-month analysis showed that sustained visual and anatomical improvements were evident in previously naïve wAMD patients treated with IVT-AFL in routine practice. The AEs were consistent with the known safety profile of IVT-AFL.