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Y. Tano, EXTEND-I study group; The Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration: 12-Month Results From the Phase I/II EXTEND-I Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):272.
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To assess the safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
This open-label, multi-center, Phase I/II study randomized 76 patients to receive either 0.3 mg ranibizumab (n=35) or 0.5 mg ranibizumab (n=41) as monthly intravitreal injections for one year. The primary efficacy endpoint was the mean change from baseline in best corrected visual acuity (BCVA). Secondary visual acuity (VA) endpoints included the proportion of patients who lost <15 letters, gained ≥15 letters, and had 20/40 Snellen equivalent VA or better. Twelve-month results are reported.
At 1 month after the first injection, patients had a mean increase in BCVA of 5.2 letters and 5.8 letters in the 0.3 mg and 0.5 mg groups, respectively. At 6 months, the mean increases from baseline in BCVA were 8.1 letters in the 0.3 mg group and 9.0 letters in the 0.5 mg group. At 12 months, mean increases in VA were 9.5 letters in the ranibizumab 0.3 mg group and 10.5 letters in the 0.5 mg group. The proportion of patients who lost <15 letters was 97.1% in the 0.3 mg group and 100% in the 0.5 mg group, and the proportion of patients who gained ≥15 letters was 37.1% in the 0.3 mg group and 31.7% in the 0.5 mg group, respectively. At 12 months, 25.7% and 31.7% of subjects had 20/40 vision or better in the 0.3 mg and 0.5 mg groups, respectively. The cumulative 12-month overall safety results were similar and consistent with the pivotal Phase III ranibizumab trials. Three subjects in the 0.5 mg group reported ocular serious adverse events: 1 retinal hemorrhage and 2 events of transient decrease in VA. There were no new obvious safety findings.
Data obtained at 12 months show that ranibizumab therapy for CNV secondary to AMD is safe and effective, in terms of VA gain and anatomical benefit, in the Japanese population. The results are similar and consistent with the results of the pivotal Phase III ranibizumab trials.
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