Status:
COMPLETED
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Lead Sponsor:
Allergan
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Known anticipated need for ocular surgery within next 12 months
- 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 :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2010
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00464685
Start Date
May 1 2007
End Date
February 8 2010
Last Update
April 24 2019
Active Locations (2)
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1
Artesia, California, United States
2
Victoria, British Columbia, Canada