Florence Coscas, Laurent Kodjikian, Michel Weber, Hassiba Oubraham-Mebroukine4, Isabelle Aubry, Salomon-Yves Cohen
Purpose: To monitor treatment-na?ve wet age- related macular degeneration (wet AMD) patients being treated with intravitreal a?ibercept (IVT-AFL) in France.
Methods: RAINBOW is an ongoing, observational, retrospective, prospective 4-year study to monitor outcomes following IVT-AFL treatment in wet AMD patients. The primary endpoint is mean change in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) from baseline to 12 months. We report 12-month outcomes.
Results: Safety data were analysed from 586 patients (safety analysis set); effectiveness data were ana- lysed from 502 patients with at least 1 follow-up (full analysis set [FAS]) and from 353 patients with visual acuity data at baseline and Month 12. Mean (SD) BCVA was 56.7 (18.2) letters and mean (SD) central retinal thickness (CRT) was 395.6 (140.5) ?m at baseline. Most patients (76.9%) received a loading dose (ftrst 3 injections within 90 days). Mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1; all patients) and 6.6 (1.8; patients who received a loading dose). Mean (SD) change in BCVA was 5.5 (15.0; all patients) and 6.8 (14.5; patients who received a loading dose) letters at Month 12 (P<0.001 vs baseline). Mean (SD) CRT reduction was ?108.7 (146.8; all patients) and ?116.4 (150.4; patients who received a loading dose) ?m at Month 12 (P<0.001 vs baseline). Over- all, 118 (20.1%) patients experienced at least 1 - treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs, and 3.9% experienced serious AEs. Conclusion: This 12-month analysis showed that IVT-AFL was associated with sustained improve- ments. RAINBOW results are consistent with the VIEW clinical studies.