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EXTEND‐I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age‐related macular degeneration
Author(s) -
Tano Yasuo,
Ohji Masahito
Publication year - 2010
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2009.01843.x
Subject(s) - ranibizumab , macular degeneration , medicine , choroidal neovascularization , adverse effect , visual acuity , ophthalmology , clinical endpoint , surgery , randomized controlled trial , bevacizumab , chemotherapy
. 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 < 0.0001) and Month 12 (0.3 mg: +9.5 letters, p = 0.0001; 0.5 mg: +10.5 letters, p < 0.0001). At Month 12, one patient (0.3 mg) and 0 patients (0.5 mg) lost ≥15 letters, while 37.1% (0.3 mg) and 31.7% (0.5 mg) of patients gained ≥15 letters. Ocular serious adverse events (SAEs) of the study eye were reported in 1 and 2 patients in the 0.3‐ and 0.5‐mg groups, respectively. Nonocular SAEs were experienced by 2 and 5 patients in the 0.3‐ and 0.5‐mg groups, respectively. No cases of endophthalmitis were reported. Conclusion: Ranibizumab was effective and well tolerated in Japanese patients with subfoveal CNV secondary to AMD.