Treatment of Diabetic Macular Edema with Pegaptanib Sodium (Macugen®)

A phase 2 randomized, multicenter, controlled, double-masked, dose-finding Study evaluated the use of intravitreal pegaptanib sodium, a selective anti-VEGF aptamer that targets VEGF165, every 6 weeks in treating diabetic macular edema (DME), for a maximum of 6 injections. Subjects receiving pegaptanib 0.3 mg were more likely than those receiving sham injections to have visual and anatomic improvements from baseline at 36 weeks. Although not as marked, gains were still evident at weeks 52 and 82. Pegaptanib also caused complete regression in about two-thirds of subjects who had concomitant proliferative diabetic retinopathy (retinal neovascularization) at baseline. The presence of retinal cysts did not appear to influence the treatment response. These preliminary findings support a role for selective VEGF inhibition in the treatment of diabetic retinopathy.