Status:
COMPLETED
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Lead Sponsor:
Allergan
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
Eligibility Criteria
Inclusion
- Key
- 18 years of age or older with diabetic macular edema;
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
- Visual acuity in other eye no worse than 20/200
- Key
Exclusion
- Known anticipated need for ocular surgery within first 12 months of study;
- History of glaucoma or current high eye pressure requiring more than 1 medication;
- Uncontrolled systemic disease;
- Known steroid-responder;
- Use of systemic steroids
- Use of Warfarin/Heparin
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT00168389
Start Date
February 1 2005
End Date
June 1 2012
Last Update
August 4 2014
Active Locations (10)
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1
Inglewood, California, United States
2
Westmead, New South Wales, Australia
3
Toronto, Ontario, Canada
4
Prague, Czechia