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Quan D. Nguyen, Jeffery Heier, David Brown, Allen Ho, Peter Kaiser, Robert Vitti, VIEW 1 Study Group; Randomized, Double-masked, Active-controlled Phase 3 Trial Of The Efficacy And Safety Of Intravitreal VEGF Trap-Eye In Wet AMD: One-year Results Of The View-1 Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3073.
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To evaluate the efficacy and safety of VEGF Trap-Eye (VTE) vs ranibizumab in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
In this non-inferiority study conducted in N. America, 1217 patients were randomized to VTE 0.5 mg every month (4 weeks; 0.5q4wk), 2 mg every month (2q4wk), 2 mg every 2 months (8 weeks; 2q8wk) following 3 monthly doses, or ranibizumab 0.5 mg every month (Rq4wk). The proportion of patients avoiding moderate vision loss (patients losing <15 ETDRS letters) from baseline to week 52 was the primary endpoint. Secondary endpoints included the mean change from baseline in best corrected visual acuity by an ETDRS letter score.
The proportions of patients maintaining vision at 52 weeks were 94.4%, 95.9%, 95.1%, and 95.1% for Rq4wk, 0.5q4wk, 2q4wk, and 2q8wk, respectively. All VTE groups were non-inferior (non-inferiority margin of 10%) to ranibizumab. Mean improvements from baseline in ETDRS letter score for Rq4wk, 0.5q4wk, 2q4wk and 2q8wk were 8.1, 6.9, 10.9, and 7.9 letters, respectively. 2q4wk was significantly better (P<0.01) than Rq4wk; differences between the other VTE groups 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. The most frequent ocular AEs were conjunctival hemorrhage, macular degeneration, eye pain, vitreous detachment, and vitreous floaters.
Dosing monthly or every two months with VEGF Trap-Eye was non-inferior to monthly ranibizumab. VEGF Trap-Eye was generally well tolerated and had a generally favorable safety profile. Based upon these results, VEGF Trap-Eye may provide convenient management of wet AMD with predictable, every two month dosing.
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