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

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ClinicalTrials.gov Identifier: NCT00040313
Recruitment Status : Completed
First Posted : June 25, 2002
Last Update Posted : May 3, 2006
Sponsor:
Information provided by:
Eyetech Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: pegaptanib sodium (Macugen) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2002
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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


ClinicalTrials.gov Identifier: NCT00040313     History of Changes
Other Study ID Numbers: EOP1005
First Posted: June 25, 2002    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: May 2006

Additional relevant MeSH terms:
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases