Original ArticlePegaptanib 1-Year Systemic Safety Results from a Safety–Pharmacokinetic Trial in Patients with Neovascular Age-Related Macular Degeneration
Section snippets
Study Design
This study was a prospective, 2-cohort, multicenter trial of the safety, tolerability, and pharmacokinetics of pegaptanib sodium administered by intravitreous injection every 6 weeks for 54 weeks in patients with AMD. Patients were recruited from 20 centers in the United States. Using an open-label run-in design, the first cohort received single intravitreous injections of 3-mg pegaptanib sodium in the study eye every 6 weeks for 54 weeks. Because the recommended dose for pegaptanib sodium had
Patient Disposition and Demographics
Of the 147 patients enrolled, 37 patients were assigned to the open-label cohort (3 mg per study eye every 6 weeks for 54 weeks), and 110 patients were assigned to the double-masked randomized cohort (54 patients to 1 mg per study eye and 56 patients to 3 mg per study eye every 6 weeks for 54 weeks). All patients received at least one treatment. A total of 1407 intravitreous injections of pegaptanib sodium were administered up to week 60. Overall, the mean number of injections received was 9.6
Discussion
Compliance was high with pegaptanib sodium intravitreous injections of 1 and 3 mg over a 1-year treatment period in this population of patients with AMD. Overall, the total number of injections administered was 1407, and the mean number of injections received was 9.6 of a possible 10 treatments, indicating high compliance throughout the 54 weeks of treatment.
No systemic safety concerns were observed, as most events other than eye disorders were infrequent and were of the type often seen in the
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Manuscript no. 2006-1167.
Study sponsored by (OSI) Eyetech Inc., New York, New York, and Pfizer Inc., New York, New York.
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Members of the Study Group taking authorship responsibility for this article and who had complete access to the data needed for this report are listed in “Appendix” (available at http://aaojournal.org).