INTRODUCTION: Long-term, global data evaluating intravitreal aflibercept (IVT-AFL) 2 mg for treatment of neovascular age-related macular degeneration (nAMD) in real-world practice are needed. This study investigated the long-term, real-world effectiveness and safety of IVT-AFL 2 mg in patients with nAMD.
METHODS: XTEND was a multicenter, observational, prospective study. Enrollment was conducted between May 2019 and May 2020; the patient follow-up period was 36 months. Treatment-naïve patients were treated with IVT-AFL 2 mg (fixed dosing or treat-and-extend [T&E]) according to the local label; for the T&E regimen, treatment intervals could be extended according to the national label (either European Medicines Agency [EMA]-aligned or non-EMA-aligned).
RESULTS: Overall, 1,483 patients across 17 countries were treated with IVT-AFL 2 mg; mean ± standard deviation (SD) age was 78.8 ± 8.5 years; 60.4% were female. Overall, 62.6% of patients completed the 36-month follow-up visit. The mean (95% confidence interval [CI]) changes in best-corrected visual acuity from baseline were +4.6 (3.7, 5.4), +2.3 (1.3, 3.3), and +0.9 (-0.2, 1.9) at months 12, 24, and 36, respectively. The mean (95% CI) changes in central subfield thickness from baseline were -106 (-114, -99) μm, -109 (-117, -102) μm, and -110 (-118, -103) μm at months 12, 24, and 36, respectively. The mean ± SD numbers of injections from baseline to months 12, 24, and 36 were 7.7 ± 2.7, 11.3 ± 5.3, and 13.7 ± 7.5, respectively. No new safety concerns were identified.
CONCLUSION: This study demonstrates that improvements with IVT-AFL 2 mg were maintained through month 36, suggesting that long-term durability of vision is achievable in patients with treatment-naïve nAMD in real-world practice.