EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Purpose: To evaluate the efficacy and safety of intravitreal ranibizumab for subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in Japanese patients. Methods: This open-label, multicentre, Phase I/II study enroled patients into Group A (single injection of ranibizumab nonrandomized doses of 0.3 or 0.5 mg followed by 11 monthly injections of the same dose) and Group B (12 monthly injections of ranibizumab randomized to 0.3 or 0.5 mg). The primary efficacy endpoint was the mean change from baseline in best-corrected visual acuity (BCVA) score at Month 6. Safety was evaluated in all patients who received ranibizumab. Results: Of 88 patients enroled, 12 entered Group A (six per dose) and 76 entered Group B (0.3 mg: n = 35; 0.5 mg: n = 41). Mean change from baseline in BCVA was significantly increased for both doses (Group B) at Month 6 (0.3 mg: +8.1 letters, p = 0.0006; 0.5 mg: +9.0 letters, p