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A Comparative Trial to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients with Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula

Principal Investigator

Ronald Gentile, M.D.

Enrollment Status

Completed

Objective

To establish the safe and efficacious dose of EYE001 when given as intravitreous injections (0.3, 1.0 or 3.0 mg/eye) as compared to control sham injections every 6 weeks for 12 to 30 weeks in patients with clinically significant macular edema (CSME) involving the macula.  This is a phase II, randomized, controlled, double-masked, dose-finding, multicenter, comparative trial, in parallel groups.

Eligibility

Patients of either gender, aged 18 years or above, diagnosed with clinically significant diabetic macular edema, with best-corrected visual acuity equal to, or worse than 68 ETDRS letters (20/50 +3) but no worse than 25 letters (≥ 20/320) in the study eye, and better than or equal to 35 ETDRS letters (≥ 20/100) in the fellow eye may be enrolled.

Study Results

In this phase II trial, subjects assigned to pegaptanib had better VA outcomes, were more likely to show reduction in central retinal thickness, and were deemed less likely to need additional therapy with photocoagulation at follow-up.

For more information: ClinicalTrials.gov

Home > Current Research > Clinical Trials in Ophthalmology > Results > A Comparative Trial to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients with Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula