Clinical Trials Directory

Trials / Completed

CompletedNCT00040313

Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
0 (planned)
Sponsor
Eyetech Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGpegaptanib sodium (Macugen)

Timeline

Start date
2002-10-01
Completion
2005-02-01
First posted
2002-06-25
Last updated
2006-05-03

Source: ClinicalTrials.gov record NCT00040313. Inclusion in this directory is not an endorsement.

Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula (NCT00040313) · Clinical Trials Directory