High-dose ranibizumab monotherapy for neovascular polypoidal choroidal vasculopathy in a predominantly non-Asian population.

摘要: To determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment active neovascular polypoidal choroidal vasculopathy (PCV). In this Phase I/II, single-center, randomized, controlled, double-masked study, predominantly non-Asian, previously treated or treatment-naive, male female adult patients were randomized to receive (1.0/0.1 ml 2.0 mg/0.05 ml; n=15) standard-dose (0.5 mg/0.05 ml; n=5) 3 monthly loading doses, followed by 9 months criteria-based, as-needed retreatment. Safety was evaluated a descriptive analysis all non-serious serious adverse events, angiographic assessments, physical examinations, vital signs, ocular visual acuity measurements. Visual anatomic outcomes are described for group. Twenty (aged 35–76 years; 8 Black, 11 White, 1 Asian) enrolled. At baseline, group, mean best-corrected (BCVA) 63.5 letters (Snellen equivalent ~20/50), baseline central foveal thickness (CFT) 253.7 μm. High-dose generally well tolerated without evidence systemic severe including arterial thromboembolic events. month 12, overall change from BCVA +6.7 CFT −49.7 μm. monotherapy is safe efficacious treating with PCV.