Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study

Abstract

Background/aims: To monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.

Methods: RAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.

Results: Safety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was -108.7 (146.8)µm and -116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.

Conclusion: This 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.

Trial registration number: NCT02279537 Pre-results.

Keywords: RAINBOW; intravitreal aflibercept; real-world evidence; wet age-related macular degeneration.

Conflict of interest statement

Competing interests: MW: Alcon, Alimera, Allergan, Bayer, Novartis, Thea; FC: Allergan, Bayer, Novartis, Roche; CF: Alcon, Bayer, Novartis; IA: Bayer; Novartis; S-YC: Alcon, Allergan, Bayer, Novartis, Thea.

Figures

Figure 1

Mean change in BCVA (letters) from baseline to month 12 in patients receiving IVT-AFL. All patients (FAS targeted): n=360 (month 3) and n=353 (months 6, 12); for patients who received a loading dose (FAS targeted): n=290 (month 3), n=276 (month 6) and n=284 (month 12) (treatment decisions were made by the physician). LOCF and median replacement analysis (FAS) n=502 (all) and n=386 (patients who received a loading dose). *P

Figure 2

Visual acuity outcomes in patients (FAS targeted) receiving IVT-AFL based on (A) 0–4, 5–9, 10–14 and ≥15 letter gains or >15 letter loss at month 12 and (B) the mean letter gains when patients were stratified by final visual acuity groups at month 12 (treatment decisions were made by the physician). *P

Figure 3

Mean change in CRT (µm) from baseline to month 12 in patients receiving IVT-AFL. All patients (FAS): n=334 (month 3), n=338 (month 6) and 333 (month 12); for patients who received a loading dose (FAS): n=267 (month 3), n=278 (month 6) and n=275 (month 12) (treatment decisions were made by the physician). *P