Abstract
Abstract: :
Purpose: We evaluated the second year safety of pegaptanib sodium injection (MacugenTM, Eyetech Pharmaceuticals), a specific vascular endothelial growth factor (VEGF) antagonist, in the treatment of neovascular age–related macular degeneration (AMD). Methods: Patients with all 3 angiographic subtypes of neovascular AMD were included in 2 concurrent, prospective, randomized, multicenter, double–masked studies. Patients received intravitreous (IVT) pegaptanib sodium (0.3 mg, 1 mg, 3 mg) or sham injection every 6 weeks for 54 weeks (9 injections) in the first year. Patients receiving pegaptanib sodium were then re–randomized (1:1) to either discontinue or continue treatment for an additional 48 weeks (8 injections). Sham–treated patients also were re–randomized (1:1:1:1:1) and could continue in the sham group, discontinue, or receive one of the pegaptanib sodium doses. Only patients who received >1 year of either pegaptanib sodium or sham were included in the analysis reported. Results: In all, 2663 IVT injections were administered to 425 patients (0.3 mg, N=128; 1 mg, N=126; 3 mg, N=120; sham, N=51) during the second year. The incidence of common ocular adverse events was similar to those reported in year 1. Most adverse events reported in study eyes were transient, mild–to–moderate in severity, and attributed to the injection procedure itself. In the 374 patients who received Macugen for >1 year, there were no cases of endophthalmitis or traumatic cataract reported; the rate of retinal detachment was 4/2663 (0.15 % per injection). No evidence of cataract progression or persistent intraocular pressure elevation following multiple IVT pegaptanib sodium injections was seen. All doses of pegaptanib sodium were well tolerated systemically, and no serious adverse events were attributed to the study drug. Conclusions: In patients with neovascular AMD, no new safety concerns were identified in a continuous second year of treatment with pegaptanib sodium. The year–2 safety profile was both favorable and similar to that described for study year 1.
Keywords: age-related macular degeneration • choroid: neovascularization • clinical (human) or epidemiologic studies: outcomes/complications