PURPOSE: To evaluate the efficacy and safety of monthly ranibizumab 0.5 mg in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD). METHODS: A 12-month open-label single-arm multicenter phase III study that included treatment-naïve (study eye) patients with primary/recurrent subfoveal CNV secondary to AMD. Patients (N = 114) aged ≥50 years with best-corrected visual acuity (BCVA) of 73-24 letters were treated with monthly ranibizumab for 12 months. Main outcomes were mean BCVA change from baseline to month 4 (primary endpoint) and over time to month 12, effects of ranibizumab treatment on retinal structure (months 4 and 12), and safety. RESULTS: Ranibizumab led to significant improvements in mean BCVA ± standard error (SE) at both months 4 and 12 versus baseline (+9.5 ± 1.10 letters, 95 % confidence interval [CI] 7.3-11.7, and +12.7 ± 1.14 letters, 95 % CI 10.4-14.9, respectively, both P < 0.0001). Ranibizumab prevented loss of vision (≥0 letters BCVA gain) in 91.2 % of patients. Mean central retinal thickness ± SE reduced from baseline to month 12 (-119.9 ± 12.97 µm, 95 % CI -145.59 to -94.20, P < 0.0001). No new safety findings were reported in this study. CONCLUSION: Ranibizumab administered monthly over 12 months was effective in improving BCVA and was well-tolerated in Chinese nAMD patients.
PURPOSE: To evaluate the efficacy and safety of monthly ranibizumab 0.5 mg in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD). METHODS: A 12-month open-label single-arm multicenter phase III study that included treatment-naïve (study eye) patients with primary/recurrent subfoveal CNV secondary to AMD. Patients (N = 114) aged ≥50 years with best-corrected visual acuity (BCVA) of 73-24 letters were treated with monthly ranibizumab for 12 months. Main outcomes were mean BCVA change from baseline to month 4 (primary endpoint) and over time to month 12, effects of ranibizumab treatment on retinal structure (months 4 and 12), and safety. RESULTS:Ranibizumab led to significant improvements in mean BCVA ± standard error (SE) at both months 4 and 12 versus baseline (+9.5 ± 1.10 letters, 95 % confidence interval [CI] 7.3-11.7, and +12.7 ± 1.14 letters, 95 % CI 10.4-14.9, respectively, both P < 0.0001). Ranibizumab prevented loss of vision (≥0 letters BCVA gain) in 91.2 % of patients. Mean central retinal thickness ± SE reduced from baseline to month 12 (-119.9 ± 12.97 µm, 95 % CI -145.59 to -94.20, P < 0.0001). No new safety findings were reported in this study. CONCLUSION:Ranibizumab administered monthly over 12 months was effective in improving BCVA and was well-tolerated in Chinese nAMD patients.