A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, Comparative Trial, in Parallel Groups, 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

Eyetech Pharmaceuticals0 sitesStarted: October 2002Last updated: May 3, 2006

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Eyetech Pharmaceuticals

Study Overview Study Design Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections. A total of 176 patients will be enrolled

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye

Exclusion Criteria

Not provided

Investigators

Sponsor

Eyetech Pharmaceuticals

Sponsor Class

Industry

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