A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
ClinicalTrials.gov ID
NCT00168298
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
668Actual
Last Update Posted
Apr 23, 2019Actual
Start Date
Nov 1, 2004Actual
Primary Completion Date
Mar 1, 2008Actual
Completion Date
Sep 5, 2008Actual
Brief Summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
Macular Edema
Retinal Vein Occlusion
700 µg Dexamethasone
350 µg Dexamethasone
Sham Injection
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
18 years of age or older with macular edema resulting from retinal vein occlusion
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 Criteria:
Known anticipated need for ocular surgery within next 12 months
History of glaucoma or current high eye pressure requiring more than 1 medication