Pegaptanib Sodium (Macugen) Compared to Sham Injection in Patients with Diabetic Macular Edema (DME) Involving the Center of the Macula - Article Caverject; Edex Kit
Clinical Trial: Pegaptanib Sodium (Macugen) Compared to Sham Injection in Patients with Diabetic Macular Edema (DME) Involving the Center of the Macula
This study is currently recruiting patients.
Verified by Eyetech Pharmaceuticals September 2005
|Diabetic Macular Edema || Drug: pegaptanib sodium (Macugen) ||Phase II |
MedlinePlus related topics: Diabetic Eye Problems; Edema; Vision Impairment and Blindness
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Dose-Finding Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreous Injections of 0.3, 0.03 or 0.003 Mg Pegaptanib Sodium (Macugen), Given as Often as Every 6 Weeks for 3 Years, to Sham Injections in Subjects with Diabetic Macular Edema (DME) Involving the Center of the Macula.
Expected Total Enrollment: 900
Study start: September 2005; Expected completion: February 2010
- Diabetic macular edema with corresponding leakage on fluorescein angiogram
- Foveal thickness of at least 300 microns on OCT.
- Best corrected visual acuity in the study eye between 20/50 and 20/200
- Women of childbearing potential must use two effective forms of contraception throughout the duration of the study
- Prior or current need for panretinal photocoagulation
- Prior treatment with an investigational agent for DME
Location and Contact Information
Valley Retina Associates, McAllen, Texas, 785003, United States; Recruiting
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00148811
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13