Wenbin Wei1, Annemarie Weisberger2, Liansheng Zhu3, Yu Cheng3, Chang Liu3. 1. Ophthalmology, Beijing Tongren Hospital of Capital Medical University, Beijing, China. Electronic address: tr_weiwenbin@163.com. 2. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. 3. China Novartis Institutes for Biomedical Research Co, Ltd, Shanghai, China.
Abstract
PURPOSE: To assess the efficacy and safety profile of intravitreal ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN: A 12-month, phase III, double-masked study. PARTICIPANTS: A total of 283 patients with BRVO. METHODS:Patients aged ≥18 years were randomized (2:1) to receive ranibizumab 0.5 mg or sham. The ranibizumab group received a minimum of 3 monthly intravitreal injections until stable maximal visual acuity (VA) was achieved followed by an individualized VA stabilization criteria-driven pro re nata (PRN) regimen. Patients in the sham group received sham injections up to month 5 and could receive ranibizumab 0.5 mg PRN from month 6. MAIN OUTCOME MEASURES: Mean average change in best-corrected VA (BCVA) from baseline to month 1 through month 6 and safety up to month 12. RESULTS: At baseline, patients' mean (standard deviation [SD]) BCVA and central subfield thickness (CSFT) were 57.4 (11.7) letters and 525 (193.4) μm, respectively. Compared with sham, ranibizumab treatment resulted in superior VA gains. The least squares (LS) mean average change in BCVA from baseline to month 1 to month 6 in ranibizumab and sham groups was +12.5 and +5.0 letters, respectively (LS mean difference between ranibizumab vs. sham: +7.5 letters [95% confidence interval, 5.5-9.5], 1-sided P < 0.001). The LS mean change from baseline at month 12 in the ranibizumab versus sham groups in BCVA was +16.4 (14.9-17.8) versus +11.4 (9.3-13.5) letters and in CSFT was -280.0 (-291.6 to -268.4) versus -269.7 (-286.2 to -253.1) μm. The mean (SD) number of injections over 12 months was 7.0 (2.55) in the ranibizumab group and 3.6 (1.60) in the sham with ranibizumab group. No new safety findings were reported. CONCLUSIONS: In Asian patients with BRVO, individualized PRN ranibizumab treatment was statistically superior to sham at month 6 and led to early visual gains that were maintained up to 12 months. Results from the sham group indicate the importance of early treatment in achieving optimal visual outcomes in BRVO. The safety of ranibizumab in this study was consistent with the well-established safety profile of ranibizumab.
RCT Entities:
PURPOSE: To assess the efficacy and safety profile of intravitreal ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN: A 12-month, phase III, double-masked study. PARTICIPANTS: A total of 283 patients with BRVO. METHODS:Patients aged ≥18 years were randomized (2:1) to receive ranibizumab 0.5 mg or sham. The ranibizumab group received a minimum of 3 monthly intravitreal injections until stable maximal visual acuity (VA) was achieved followed by an individualized VA stabilization criteria-driven pro re nata (PRN) regimen. Patients in the sham group received sham injections up to month 5 and could receive ranibizumab 0.5 mg PRN from month 6. MAIN OUTCOME MEASURES: Mean average change in best-corrected VA (BCVA) from baseline to month 1 through month 6 and safety up to month 12. RESULTS: At baseline, patients' mean (standard deviation [SD]) BCVA and central subfield thickness (CSFT) were 57.4 (11.7) letters and 525 (193.4) μm, respectively. Compared with sham, ranibizumab treatment resulted in superior VA gains. The least squares (LS) mean average change in BCVA from baseline to month 1 to month 6 in ranibizumab and sham groups was +12.5 and +5.0 letters, respectively (LS mean difference between ranibizumab vs. sham: +7.5 letters [95% confidence interval, 5.5-9.5], 1-sided P < 0.001). The LS mean change from baseline at month 12 in the ranibizumab versus sham groups in BCVA was +16.4 (14.9-17.8) versus +11.4 (9.3-13.5) letters and in CSFT was -280.0 (-291.6 to -268.4) versus -269.7 (-286.2 to -253.1) μm. The mean (SD) number of injections over 12 months was 7.0 (2.55) in the ranibizumab group and 3.6 (1.60) in the sham with ranibizumab group. No new safety findings were reported. CONCLUSIONS: In Asian patients with BRVO, individualized PRN ranibizumab treatment was statistically superior to sham at month 6 and led to early visual gains that were maintained up to 12 months. Results from the sham group indicate the importance of early treatment in achieving optimal visual outcomes in BRVO. The safety of ranibizumab in this study was consistent with the well-established safety profile of ranibizumab.