Impact of intravitreal aflibercept dosing regimens in treatment-naïve patients with neovascular age-related macular degeneration: 2-year results of RAINBOW

Michel Weber, Marcel Dominguez, Florence Coscas, Céline Faure, Stéphanie Baillif, Laurent Kodjikian, Salomon-Yves Cohen, Michel Weber, Marcel Dominguez, Florence Coscas, Céline Faure, Stéphanie Baillif, Laurent Kodjikian, Salomon-Yves Cohen

Abstract

Background: To review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) injection.

Methods: RAINBOW (ClinicalTrials.gov, NCT02279537) is an ongoing, observational, 4-year study to monitor the effectiveness and safety of IVT-AFL in patients with nAMD in clinical practice in France. Treatment-naïve patients diagnosed with nAMD who had been prescribed IVT-AFL by their treating physician were eligible. The regimens of interest were regular treatment interval cohort (patients who received three initial monthly IVT-AFL injections followed by regular injections every 2 months) and two irregular treatment interval cohorts (with and without three initial monthly injections). Here we describe results at 24 months in patients according to IVT-AFL treatment regimen.

Results: The mean change in best-corrected visual acuity (BCVA) with IVT-AFL from baseline to 24 months was + 3.0 letters in the overall population (P < 0.05 vs baseline). The mean change was positive for the regular and irregular treatment interval cohorts with initial doses (+ 4.9 and + 4.0 letters, respectively; P < 0.05 vs baseline) and negative for the irregular treatment interval cohort without initial doses (- 2.5 letters; P = 0.365 vs baseline) at 24 months. The mean overall number of IVT-AFL injections over 12 and 24 months was 6.0 and 8.8, respectively. The most common ocular adverse events were lack of efficacy (6.3%), vitreous floaters (2.7%), and increased lacrimation (1.7%).

Conclusions: In the real-world RAINBOW study, visual outcomes observed at 24 months were consistent with results from the primary endpoint at 12 months. In this study, treatment-naïve patients who received three initial IVT-AFL doses and regular IVT-AFL treatment over the first 24 months experienced better visual outcomes than patients who received no initial doses and an irregular treatment regimen.

Trial registration: www.ClinicalTrials.gov (NCT02279537). Registered 29 October 2014.

Keywords: France; Intravitreal aflibercept; Neovascular age-related macular degeneration; Observational; Real-world.

Conflict of interest statement

MW reports personal fees from Bayer, outside the submitted work; MD reports support with clinical studies from Bayer and Novartis, during the conduct of the study and outside of the submitted work; FC reports personal fees from Bayer, personal fees from Novartis, personal fees from Roche, outside the submitted work; CF reports grants from Novartis, grants from Allergan, grants from Bayer, outside the submitted work; SB reports personal fees and other from Bayer Healthcare, personal fees and other from Horus Pharma, personal fees and other from Novartis SAS, personal fees and other from Allergan SAS, outside the submitted work; LK reports grants and personal fees from Allergan, personal fees from Bayer, grants and personal fees from Novartis, outside the submitted work; SYC reports personal fees from Bayer, during the conduct of the study; personal fees from Novartis, personal fees from Bayer, personal fees from Allergan, personal fees from Thea, personal fees from Tilak, personal fees from Roche, outside the submitted work.

Figures

Fig. 1
Fig. 1
Patient disposition during the study. BCVA best-corrected visual acuity, FAS full analysis set, M0 Month zero
Fig. 2
Fig. 2
Change in visual acuity over 12 and 24 months according to intravitreal aflibercept regimen. Observed analysis. *P < 0.05 versus baseline. BCVA best-corrected visual acuity, FAS full analysis set, IDs, initial doses, irreg irregular, reg regular, n number or patients
Fig. 3
Fig. 3
Mean BCVA score at baseline and at Month 24. FAS targeted: n = 264. Regular treatment interval cohort: n = 70. Irregular treatment interval cohort with initial doses: n = 142. Irregular treatment interval cohort without initial doses: n = 40. BCVA best-corrected visual acuity, ETDRS Early Treatment Diabetic Retinopathy Study, FAS full analysis set
Fig. 4
Fig. 4
Proportion of patients with a BCVA ≥70 letters by IVT-AFL regimen. Observed analysis. Regular treatment interval cohort: n = 102 (month 0); n = 102 (month 12); n = 70 (month 24). Irregular treatment interval cohort with initial doses: n = 268 (month 0); n = 268 (month 12); n = 142 (month 24). Irregular treatment interval cohort without initial doses: n = 60 (month 0); n = 60 (month 12); n = 40 (month 24). BCVA best corrected visual acuity, IVT-AFL intravitreal aflibercept

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