First patient enrolled in phase III pegaptanib trial for DME, diabetic retinopathy

Chicago-Eyetech Pharmaceuticals Inc. announced on Monday the enrollment of the first patient in a phase III randomized, controlled, double-masked, multicenter, comparative dose-finding trial that will compare the safety and efficacy of pegaptanib sodium injection (Macugen) in patients with diabetic macular edema (DME).

Diabetic retinopathy score is a pre-specified secondary endpoint of the phase III study. Patients in the phase III study will receive intravitreous injections of 0.3, 0.03, or 0.003 mg of pegaptanib sodium, or sham injections, every 6 weeks for 3 years. Total planned enrollment for the trial is 900 patients. Enrollment is anticipated to be complete by February 2007.

Pegaptanib sodium is indicated in the United States for the treatment of neovascular age-related macular degeneration and is not approved for the treatment of DME or diabetic retinopathy.

For more information visit the Eyetech Pharmaceuticals Booth 3544.