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O. Kwon, F. Lee, H. Chung, C.-C. Lai, S.-J. Sheu, Y.-H. Yoon, on behalf of the EXTEND III study group; Safety and Efficacy of Ranibizumab in Asian Patients With Neovascular Age-related Macular Degeneration: 4- and 12-months Results of the EXTEND III Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2365.
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To evaluate the safety and efficacy of monthly ranibizumab intravitreal injections in Asian patients with neovascular age-related macular degeneration (AMD).
In the open-label, single-treatment arm EXTEND III study, 95 AMD patients (12 centers in South Korea and Taiwan) were treated monthly with ranibizumab (0.5 mg) over 12 months. Best-corrected visual acuity (BCVA) was assessed monthly using Early Treatment for Diabetic Retinopathy Study charts. Vascular leakage and lesion size were assessed monthly by fluorescein angiography.
Adverse events (AEs) were reported in 33.7% of patients. The most frequent ocular AEs were conjunctival hemorrhage (8.4%) and increased intraocular pressure (7.4%). The most frequent non-ocular AEs were nasopharyngitis (4.2%) and prostate cancer (4.2%). Serious AEs occurred in 10.5% of patients with prostate cancer being reported the most frequently (n=4). Ocular SAEs, myocardial infarction, or stroke were not observed. The mean change of BCVA from baseline to Month 4 (primary efficacy endpoint) was 9.3 letters (10.1 letters in Taiwanese and 8.3 letters in Korean patients). At Month 4 65.3% of patients gained ≥5 letters and 27.4% of patients improved by ≥15 letters. 38.9% of patients had complete absence of leakage at Month 4. Mean total lesion area decreased significantly from baseline to Month 4 by 1.79 mm2 to 3.23 mm2. Twelve-month results will be available at the time of presentation.
The overall safety and efficacy results of this study were consistent with those from earlier pivotal clinical studies performed in Caucasian AMD patients and suggest that monthly treatment with ranibizumab (0.5 mg) on average also improves visual acuity in Asian AMD patients.
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