Original ArticleA Phase II Randomized Double-Masked Trial of Pegaptanib, an Anti–Vascular Endothelial Growth Factor Aptamer, for Diabetic Macular Edema
Section snippets
Study Design
This study was a randomized, controlled, double-masked, parallel-group, dose-finding, phase II trial. Patients with DME were enrolled at 39 sites. The study was conducted in conformance with the principles of the Declaration of Helsinki and with the laws of the country in which the research was conducted. Institutional review board or ethics committee approval was obtained at all sites, and each patient provided signed informed consent before study entry.
Subject Selection
Patients 18 years or older of either
Results
All 172 randomized subjects (0.3 mg, n = 44; 1 mg, n = 44; 3 mg, n = 42; sham, n = 42) were included in the intention-to-treat analyses; data were missing for 1 patient each in the 1-mg and sham groups. A total of 169 individuals received at least one study treatment and were included in the safety analyses (0.3 mg, n = 44; 1 mg, n = 42; 3 mg, n = 42; sham, n = 41). Baseline demographic and ocular characteristics were well balanced across all treatment groups (Table 1). More than 90% of study
Discussion
The totality of our results suggests an overall VA gain as well as a reduced risk of VA loss in eyes with DME (as recognized on OCT) treated with intravitreous pegaptanib. The 0.3-mg dose seemed to be the most efficacious dose studied. Outcomes appeared to favor the 0.3-mg dose with respect to mean VA, greater decrease in retinal thickness, and less need for focal/grid laser intervention. Due to the relatively small number of participants in the study, however, we were unable to identify
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Manuscript no. 2005-273.
The study was sponsored by Eyetech Pharmaceuticals, Inc., New York, New York, and Pfizer Inc., New York, New York.