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D.J. D'Amico, VEGF Inhibition Study in Ocular Neovascularization(VISION) Clinical Trial Group; VEGF Inhibition Study in Ocular Neovascularization (VISION): Second Year Efficacy Data . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2309.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: We assessed the safety and efficacy of pegaptanib sodium injection (MacugenTM, Eyetech Pharmaceuticals) through 102 weeks in patients with neovascular age–related macular degeneration (AMD). Methods: Patients with all angiographic subtypes of AMD were included in 2 randomized, double–masked, sham–controlled, multicenter studies. During the first year, patients received either intravitreous pegaptanib sodium injection (0.3 mg, 1 mg, 3 mg) or sham injection every 6 weeks for 54 weeks. Patients originally assigned to pegaptanib sodium were then re–randomized (1:1) to continue or discontinue therapy for an additional 48 weeks (8 injections). Those assigned to sham in year 1 were re–randomized either to continue sham, discontinue sham, or receive one of the 3 pegaptanib sodium doses. Results: In combined analyses, 88% (1053/1190) of patients receiving ≥1 treatment at baseline were re–randomized at week 54, 89% (941/1053) of re–randomized patients were assessed at week 102, and re–randomized patients received an average of 15.7 of a possible 17 injections (92%) over 2 years. Between baseline and Week 102, patients re–randomized to continue pegaptanib sodium 0.3 mg for a second year lost a mean of 9.4 letters of visual acuity compared with a loss of 17.0 letters for controls (45% relative treatment effect, P≤0.05). Loss of <15 letters occurred in 59% (78/133) of patients re–randomized to continue a second year of pegaptanib sodium, versus 45% (48/107) of controls (P<0.05). In patients continuing treatment in year 2, 67% more events of 3–line loss were noted in those receiving 1 year versus 2 years of therapy (35 events in the 1–year group vs. 21 events in the 2–year group; P≤0.05). No new ocular safety issues or systemic safety concerns emerged during a second year of therapy. Conclusions: A sustained treatment benefit is observed during year 2 with intravitreous pegaptanib sodium therapy, and this benefit appears to be greater after 2 years of treatment than after only 1 year of therapy. The safety profile remains favorable throughout the entire 2 years of treatment.
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