Session Title: Free Paper Session 3: AMD I
Session Date/Time: Thursday 07/09/2017 | 08:30-10:00
Paper Time: 09:18
Venue: Room 118
First Author: : F.Coscas FRANCE
Co Author(s): : L. Kodjikian M. Weber H. Oubraham-Mebroukine I. Aubry S. Cohen
The aim of the RAINBOW study is to monitor the real-world effectiveness and safety of intravitreal aflibercept (IVT-AFL) in treatment-naïve patients with wet age-related macular degeneration (wAMD). It is important to monitor resource patterns and outcomes following anti-vascular endothelial growth factor (VEGF) treatment in clinical settings, as the results achieved under strict protocols in randomised studies may not always be achieved in routine practice.
RAINBOW is an ongoing, observational, retrospective and prospective 4-year study being conducted in 55 French centres. Patients with wAMD who received their first IVT-AFL injection between January 2014 and March 2015 were screened and will be followed for a period of 4 years or until study discontinuation.
Patients who were diagnosed with wAMD and had been prescribed IVT-AFL by their treating physician were eligible. Prior or current treatment with any anti-VEGF agent or macular laser in the study eye was not allowed. The study eye was defined as the worse-seeing eye of each patient, but the second eye was also considered for the study if it was treatment naïve. The study is ongoing, and the primary outcome is the mean change in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) from baseline to 12 months. Other outcomes include the proportion of patients who gain ≥15 letters, proportion of patients who achieve ≥70 letters, mean change in central retinal thickness (CRT), and safety. We report the updated 12-month outcomes. Safety data were analysed from 586 patients (safety analysis set), efficacy data were analysed from 502 patients (full analysis set [FAS]) and from 353 patients with visual acuity data at baseline and Month 12 (FAS targeted).
The mean (SD) BCVA was 56.7 (18.2) letters, and mean (SD) CRT was 395.9 (140.7) µm at baseline. Most patients (76.9%) received a loading phase (first 3 injections within 90 days). The mean (SD) number of IVT-AFL injections was 6.0 (2.1) (all FAS) and 6.6 (1.8) (patients who received a loading phase) over 12 months. Mean (SD) change in BCVA was 5.5 (15.0) letters (all FAS targeted) and 6.8 (14.5) letters (patients who received a loading phase) at Month 12 (P<0.001 vs baseline). The proportion of patients who gained ≥15 letters at Month 12 was 25.2% (all FAS targeted) and 28.9% (patients who received a loading phase), and the proportion who achieved ≥70 letters was 45.9% and 45.4%, respectively. Mean (SD) CRT reduction was –108.7 (146.8) µm (all FAS) and –116.4 (150.4) µm (patients who received a loading phase) at Month 12 (P<0.001 vs baseline). Overall, 118 (20.1%) patients experienced ≥1 treatment-emergent adverse event (TEAE), 1.9% experienced at least 1 treatment-related TEAE, which included eye/injection pain (n=4), blurred vision (n=3), and vitreous floaters (n=2). Serious AEs (ocular and nonocular) were reported in 3.9% of patients, and included sudden death (n=1), ischaemic stroke (n=2), and treatment-related transient ischaemic attack (n=1).
This 12-month analysis showed that sustained visual and anatomical improvements were evident in treatment-naïve wAMD patients treated with IVT-AFL in routine practice. Patients who received a loading phase also experienced better outcomes at Month 12. The ocular TEAEs reported were also consistent with the known safety profile of IVT-AFL. RAINBOW showed that outcomes achieved with IVT-AFL (after a loading phase) in randomised studies, such as VIEW, can be achieved in a real world setting. RAINBOW also highlights improvements in patient management and outcomes compared with those reported in earlier observational studies with other anti-VEGF agents.