OSI/Eyetech Pharmaceuticals Inc. (Melville, NY, and New York) began enrollment of a phase III trial to determine the safety and efficacy of pegaptanib sodium injection (Macugen) in patients with diabetic macular edema (DME). Patients will receive intravitreous injections of 0.3, 0.03, or 0.003 mg of pegaptanib sodium, or placebo injections, every 6 weeks for 3 years.
The randomized, controlled, double-masked, multicenter, and comparative dose-finding trial will use the diabetic retinopathy score as a pre-specified secondary endpoint. Enrollment is scheduled to conclude February 2007 and is anticipated to include 900 patients.
"In limited phase II studies, Macugen, the only anti-VEGF (vascular endothelial growth factor) therapy being studied in DME and diabetic retinopathy in large clinical trials, has shown potential in treating these conditions," said Michael Altaweel, MD, department of ophthalmology and visual sciences, University of Wisconsin, Madison.
The drug, a pegylated anti-VEGF aptamer that binds to VEGF, is indicated in the United States and Brazil for the treatment of neovascular age-related macular degeneration (AMD) and in Canada for the treatment of subfoveal choroidal neovascularization secondary to AMD.