Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
ClinicalTrials.gov ID
NCT00464685
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
253Actual
Last Update Posted
Apr 24, 2019Actual
Start Date
May 1, 2007Actual
Primary Completion Date
Feb 8, 2010Actual
Completion Date
Feb 8, 2010Actual
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.
Diabetic Macular Edema
Dexamethasone
Sham injection
Laser Photocoagulation
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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