Abstract
BackgroundTo review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) injection.MethodsRAINBOW (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.ResultsThe 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%).ConclusionsIn 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 registrationwww.ClinicalTrials.gov (NCT02279537). Registered 29 October 2014.
Highlights
To review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration treated with intravitreal aflibercept (IVT-AFL) injection
In the Real Life of intravitreal Aflibercept In FraNce: oBservatiOnal study in Wet age-related macular degeneration (AMD) (RAINBOW) study, patients treated with IVTAFL for neovascular age-related macular degeneration (nAMD) were expected to receive three initial monthly injections followed by injections every 2 months for the first 12 months, with extensions based on visual and anatomic outcomes thereafter [4]
Patients Data from 514 patients who had best-corrected visual acuity (BCVA) scores at baseline and at least one follow-up assessment were included in this 24-month analysis
Summary
To review treatment outcomes from real-world data of patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) injection. Anti-vascular endothelial growth factor (anti-VEGF) agents, such as intravitreal aflibercept (IVT-AFL) and ranibizumab, are available for the treatment of neovascular age-related macular degeneration (nAMD), and the goal of disease management beyond the first year is to maintain or improve functional and anatomical gains while minimizing the burden on patients of clinic visits and injections [2]. In the Real Life of intravitreal Aflibercept In FraNce: oBservatiOnal study in Wet AMD (RAINBOW) study, patients treated with IVTAFL for nAMD were expected to receive three initial monthly injections followed by injections every 2 months for the first 12 months, with extensions based on visual and anatomic outcomes thereafter [4]. The purpose of this study was not to identify differences in clinical practices before and after any changes in approved dosing for IVTAFL, but rather to describe clinically led variations in treatment practices in France and understand any impact of those on patient outcomes
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