Pegaptanib for Neovascular Age-Related Macular Degeneration

摘要: background Pegaptanib, an anti–vascular endothelial growth factor therapy, was evaluated in the treatment of neovascular age-related macular degeneration. methods We conducted two concurrent, prospective, randomized, double-blind, multicenter, dose-ranging, controlled clinical trials using broad entry criteria. Intravitreous injection into one eye per patient pegaptanib (at a dose 0.3 mg, 1.0 or 3.0 mg) sham injections were administered every 6 weeks over period 48 weeks. The primary end point proportion patients who had lost fewer than 15 letters visual acuity at 54 results In combined analysis (for total 1186 patients), efficacy demonstrated, without dose–response relationship, for all three doses (P<0.001 comparison mg with injection; P<0.001 and P=0.03 injection). group given 70 percent acuity, as compared 55 among controls (P<0.001). risk severe loss (loss 30 more) reduced from 22 sham-injection to 10 receiving More (0.3 mg), injection, maintained their gained (33 vs. 23 percent; P=0.003). As early six after beginning therapy study drug, subsequent points, mean better those (P<0.002). Among adverse events that occurred, endophthalmitis (in 1.3 traumatic injury lens 0.7 percent), retinal detachment 0.6 percent) most serious required vigilance. These associated 0.1 patients. conclusions Pegaptanib appears be effective Its long-term safety is not known.