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| Sponsored by: |
Eyetech Pharmaceuticals |
| Information provided by: | Eyetech Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00040313 |
Purpose
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 | Intervention | Phase |
|
Diabetic Macular Edema |
Drug: pegaptanib sodium (Macugen) |
Phase II |
| Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
| MedlinePlus related topics: | Edema |
| ChemIDplus related topics: | Bevacizumab Pegaptanib sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
| Study ID Numbers: | EOP1005 |
| First Received: | June 24, 2002 |
| Last Updated: | May 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00040313 |
| Health Authority: | United States: Food and Drug Administration |
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