One-Year Real-World Outcomes of Intravitreal Aflibercept 8 mg for Neovascular Age-Related Macular Degeneration in Japan: A Multicenter Retrospective Study

Background: Intravitreal anti–vascular endothelial growth factor (anti-VEGF) therapy has improved outcomes in neovascular age-related macular degeneration (nAMD), but treatment burden remains substantial in real-world practice. High-dose aflibercept 8 mg was developed to extend dosing intervals; however, one-year real-world evidence in Japanese patients is limited. Objective: To evaluate one-year real-world efficacy, durability, and safety of aflibercept 8 mg for nAMD in Japan. Methods: This multicenter retrospective study was conducted across five institutions in Japan and included consecutive eyes with nAMD treated with aflibercept 8 mg between April and December 2024 and followed for at least 12 months. Visual acuity (VA; logMAR) and central subfield thickness (CST) were assessed at baseline and follow-up visits. Treatment followed an individualized treat-and-extend approach; 19, 1, and 20 eyes received 1, 2, and 3 loading injections, respectively. Durability was evaluated by comparing pre-switch and 12-month dosing intervals in eyes with paired data. Results: Forty eyes (36 patients) were analyzed: 35 previously treated eyes switched to aflibercept 8 mg and 5 treatment-naïve eyes. Median baseline VA was 0.155 logMAR and CST was 284 μm. VA at 12 months did not differ significantly from baseline (Hodges–Lehmann − 0.0395 logMAR; 95% CI, − 0.111 to 0.0141; p = 0.148), whereas CST decreased significantly (− 62.0 μm; 95% CI, − 106 to − 32.0; p = 0.000538). Among eyes with paired pre-switch interval data (n = 35), injection intervals increased from 8 weeks (IQR, 7– 12) to 12 weeks (IQR, 8– 14) at 12 months (median change +2 weeks; p = 0.00471). No ocular or systemic adverse events potentially related to aflibercept 8 mg were observed. Conclusion: In this Japanese real-world nAMD cohort, significant CST reduction was observed over 12 months, while visual acuity remained stable. Longer dosing intervals were also observed after switching. Keywords: neovascular age-related macular degeneration, aflibercept 8 mg, treat-and-extend, optical coherence tomography, real-world study