[Long-term efficacy and safety profile of pegaptanib sodium for age-related macular degeneration with choroidal neovascularization--evaluation of extended phase II clinical trial].

Long-term efficacy and safety profile of pegaptanib was evaluated for age-related macular degeneration (AMD) with choroidal neovascularization. Sixty-one AMD patients from phase II clinical trial were entered into an extended trial and followed up for more than 2 years. Pegaptanib sodium 0.3 mg was administered once every six weeks. Changes in visual acuity were evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The number of responders and adverse events were monitored. The mean change in visual acuity decreased by 10.3 letters for up to 199 weeks (62-199 weeks; mean 140 weeks) during follow-up. There were 77.4% responders at the beginning (54 weeks since the beginning of phase II trial) and 56.6% at the end of the extended trial. Adverse events were found in 57 of 61 patients (93.4%); 36 of the events (59.0%) were due to a preparation procedure, while 12 adverse events (19.7%), including retinal hemorrhage (3 events; 4.9%), anterior chamber inflammation (2 events; 3.3%), macular degeneration, floaters, photopsia, retinal vessel aneurysm, vitreous hemorrhage, ocular hypertension, arteriosclerosis obliterans and hypertension (1 event; 1.6%, respectively) were associated with pegaptanib sodium. Thus, the majority of adverse events was at least in part a result of the preparation procedure for injection. Based on the long-term efficacy and tolerability data of this trial, pegaptanib sodium appears to be beneficial for preventing the worsening of visual acuity caused by age-related macular degeneration with choroidal neovascularization.