Abstract / Summary
Abstract Background We aimed to compare the incidences of submacular hemorrhage (SMH) under two treat-and-extend regimens with aflibercept (IVA) and faricimab (IVFa) in patients with neovascular age-related macular degeneration (nAMD) and to perform exploratory analyses of age-stratified SMH incidence. Methods This retrospective single-center observational study included treatment-naïve nAMD eyes treated with IVA or IVFa and followed for at least 12 months. The primary outcome was SMH incidence within 1 year. Secondary analyses included SMH incidence stratified by age and macular neovascularization subtype, time to SMH onset, and visual outcomes according to SMH occurrence. Logistic regression and exploratory receiver operating characteristic analyses were performed to assess the relationship between age and SMH occurrence. Results A total of 238 eyes from 232 patients were included (IVA: 193 eyes; IVFa: 45 eyes). Overall SMH incidence was numerically higher in the IVA group than in the IVFa group (8.8% vs. 2.2%), although the difference was not significant ( P = 0.21). Exploratory age-stratified analysis showed that patients aged ≤ 82 years had a lower incidence of SMH in the IVFa group than in the IVA group (0% vs. 9.7%; P < 0.05). SMH occurred predominantly in eyes with type 1 macular neovascularization and polypoidal choroidal vasculopathy, with no significant difference in subtype distribution between the groups. Eyes with SMH showed significant visual deterioration over 1 year, whereas eyes without SMH demonstrated significant visual improvement. Logistic regression analysis showed no significant association between age and SMH occurrence ( P = 0.54), and receiver operating characteristic curve analysis demonstrated limited discriminatory ability of age alone (AUC = 0.56). Conclusions Although no significant difference in overall SMH incidence was observed between the treatment groups, our exploratory age-stratified analysis suggested a lower incidence of SMH among patients aged ≤ 82 years treated with IVFa. Given the exploratory nature of this finding, larger prospective studies are warranted to confirm these observations.