Clinical ophthalmology (Auckland, N.Z.) · 2026
One-Year Real-World Outcomes of Intravitreal Aflibercept 8 mg for Neovascular Age-Related Macular Degeneration in Japan: A Multicenter Retrospective Study.
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Mizuma Rikuto, Mizuki Yuki, Kamata Akihiro, Onishi Junji, Sakono Takuto, Suzuki Misa, Mizuki Nobuhisa
Аннотация
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.
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.