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Daniel B. Roth, Jeffrey S. Heier, Desmond Thompson, Yuhwen Soo, Robert Vitti, Namrata Saroj, Alyson J. Berliner, Georg Groeztbach, Olaf Sowade, Oliver Zeitz; Cumulative Incidence of Visual Acuity Change in the VIEW 1 and VIEW 2 Studies of Patients with Neovascular Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2042.
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To test the hypothesis that the time to sustained visual acuity gain or loss in wet AMD patients is similar among different dosing regimens of intravitreal aflibercept injection (IAI; also referred to as VEGF Trap-Eye), including every-two-month dosing, and monthly ranibizumab.
A total of 2457 patients with AMD from VIEW 1 and VIEW 2 were randomized to four treatment groups: ranibizumab 0.5 mg every 4 weeks (Rq4wk), IAI 2 mg every 4 weeks (2q4wk), 0.5 mg every 4 weeks (0.5q4wk), and 2 mg every 8 weeks (2q8wk, after 3 initial monthly doses). In this study, the pre-specified analysis assessed the temporal pattern of the cumulative incidence of the following events: first gain or loss of ≥15 letters (simple event) and first ≥2 consecutive occurrences gain or loss of ≥15 letters (sustained event). Kaplan-Meier methodology was used to compare the cumulative incidence curves for the treatment groups. The analysis was adjusted for varying patterns of censorship.
Outcomes for ≥15 letters at Week 52 are shown in the table.Cumulative incidence curves did not differ among the four dosing regimens for the two anti-VEGF agents: P=0.69, P=0.75, P=0.92 and P=0.92 for the respective outcomes listed in the first column of the table. Improvement in vision was observed early in all treatment groups.
Temporal patterns in visual acuity gain or loss were similar among all treatment groups, indicating that the every-two-months treatment with intravitreal aflibercept injection was as beneficial as monthly doses of intravitreal aflibercept injection or ranibizumab.
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