Name

386 - RAINBOW : étude observationnelle évaluant l’utilisation de l’Aflibercept en pratique courante en France pour le traitement de la forme humide de la DMLA (Real Life of Aflibercept In FraNce: oBservatiOnal study in Wet AMD)

To collect real-world data on patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept injection (IVT-AFL).

RAINBOW (NCT02279537) is an ongoing observational, retrospective and prospective, 4-year study to monitor the effectiveness and safety of IVT-AFL in patients with nAMD in clinical practice in France. Patients diagnosed with nAMD who had been prescribed IVT-AFL by their treating physician were eligible. The regimens of interest were: regular cohort (patients who received 3 initial monthly IVT-AFLs [–1/+2 weeks] followed by regular injections every 2 months [–3/+4 weeks] and at least 6 injections during the first 12 months) and 2 irregular cohorts, with and without 3 initial monthly injections (patients who received IVT-AFL every <2 or >2 months with or without 3 initial monthly injections). Primary endpoint was change in best-corrected visual acuity (BCVA) from baseline to Month 12. Interim results at 24 months in patients according to IVT-AFL treatment regimen are presented here.

The mean change from baseline in BCVA in Early Treatment Diabetic Retinopathy letters was +2.5 (all cohorts), +4.0 (regular cohort), and +4.0 (irregular cohort with 3 initial monthly injections) at 24 months (all groups P<0.05 vs baseline), and –4.1 (irregular cohort without 3 initial monthly injections) at 24 months. The mean number of IVT-AFLs was 10.7 (regular cohort; n=102), 9.3 (irregular cohort with 3 initial monthly injections; n=265), and 7.8 (irregular cohort without 3 initial monthly injections; n=61). For each cohort this was a decrease from the change in visual acuity achieved at 12 months. The proportion of patients achieving ≥70 letters was 46.3% (all cohorts). Ocular and non-ocular treatment-emergent adverse events (AEs) were reported in 17.1% and 19.4% of patients, respectively. The most common ocular AEs were lack of response (2.7%), vitreous floaters (2.0%), lacrimation increased (1.4%), and eye pain (1.2%).

Results from RAINBOW at 24 months are consistent with results from the primary endpoint at 12 months.

Interim results from RAINBOW highlight the importance of 3 initial monthly IVT-AFLs on visual outcomes at 24 months in patients with nAMD.