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Ursula Schmidt-Erfurth, Victor Chong, Bernd Kirchhof, Jean-Francois Korobelnik, András Papp, Majid Anderesi, Georg Groetzbach, Bernd Sommerauer, Rupert Sandbrink, Yuichiro Ogura; Primary Results of an International Phase III Study Using Intravitreal VEGF Trap-Eye Compared to Ranibizumab in Patients with Wet AMD (VIEW 2). Invest. Ophthalmol. Vis. Sci. 2011;52(14):1650.
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To evaluate efficacy and safety of different dose and interval regimens of VEGF Trap-Eye (VTE) vs monthly ranibizumab in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) at 12 months in a international setting.
A total of 1240 patients from Europe, Latin America, Asia, and Australia were randomized to VTE 0.5 mg monthly (4 weeks; 0.5q4wk), 2 mg monthly (2q4wk), 2 mg every two months (8 weeks; 2q8wk) following 3 monthly doses, or ranibizumab 0.5 mg monthly (Rq4wk). The primary endpoint was the proportion of patients maintaining vision (loss <15 ETDRS letters) from baseline to week 52. Secondary endpoints included mean change in best corrected visual acuity (BCVA) at Week 52. Central retinal thickness was assessed monthly.
There were 72.4% Caucasian and 21.6% Asian patients included. The proportions of patients maintaining vision at week 52 were 94.4%, 96.3%, 95.6%, and 95.6% for Rq4wk, 0.5q4wk, 2q4wk, and 2q8wk, respectively. All VTE arms were non-inferior to ranibizumab. Mean improvements in BCVA for Rq4wk, 0.5q4wk, 2q4wk and 2q8wk were 9.4, 9.7, 7.6, and 8.9 letters; differences between the VTE arms and Rq4wk were non-significant. The incidences of ocular treatment emergent adverse events (AEs) were similar across all treatments, with the most frequent AEs associated with the injection procedure, the underlying disease, and/or the aging process. Conjunctival hemorrhage, macular degeneration, retinal hemorrhage, and reduced visual acuity were the most frequent ocular AEs. There were no concerns regarding systemic safety in any arm.
Across different ethnicities, VEGF Trap-Eye monthly or every two months was non-inferior to monthly treatment with ranibizumab with a favorable safety profile. Based on the study data, the new management paradigm in wet AMD with treatment every two months using VEGF Trap-Eye can be recommended regardless of the ethnicity.
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