Name

015 - 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)

The aim of RAINBOW is to assess the real-world effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients with wet age-related macular degeneration (wAMD).

RAINBOW is an ongoing, observational, retrospective and prospective 4-year study in France. Treatment-naïve patients with wAMD receiving first IVT-AFL injection between January 2014 and March 2015 were enrolled. Study eye was defined as worse-seeing eye of each patient, but second eye was also considered if treatment naïve. Primary outcome is mean change in best-corrected visual acuity (VA) (ETDRS letters) from baseline to 12 months. We report updated 12-month outcomes in patients stratified by treatment regimen.

Safety (n=593) and efficacy (n=428) data were analysed. VA outcomes were monitored in patients receiving a loading dose (3 initial monthly IVT-AFL injections [–1/+2 weeks]) followed by regular treatment (intervals of 2 months [–3/+4 weeks] and ≥6 IVT-AFL injections during the first 12 months) (n=102) or irregular treatment (with injection intervals different from regular treatment) (n=266), and in patients with no loading dose and irregular treatment (n=60) (Table). Proportion of patients gaining ≥15 letters was 25.2%, proportion achieving ≥73 letters was 35.7%, and mean change in central retinal thickness was –110.4 µm at 12 months. Ocular and nonocular treatment-emergent adverse events (AEs) were reported in 14.7% and 17.4% of patients, respectively. Most common ocular AEs were vitreous floaters (1.9%), lack of response (1.3%), eye pain (1.2%), and lacrimation increased (1.2%). Sudden death was reported in 4 patients (none treatment-related).

*P<0.001 vs baseline; †P<0.001 vs irregular cohort without loading dose; ‡P=0.003 vs irregular cohort without loading dose. **n=513. SD, standard deviation.

In this interim analysis, visual and anatomic improvements were achieved at Month 12 following IVT-AFL treatment. Patients receiving regular treatment (every 2 months) following 3 initial monthly injections experienced significantly greater VA gains vs. those with irregular treatment. Likewise, within the irregular group, patients with loading dose achieved better results vs. those without. Ocular AEs were consistent with the known safety of IVT-AFL.

Some variabilities according to treatment protocol have been observed. The best results have been obtained with both loading dose and regular treatment, and these results appeared quite similar to those in the randomized VIEW studies.