Status:
COMPLETED
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Lead Sponsor:
Allergan
Conditions:
Macular Edema
Retinal Vein Occlusion
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 macular edema associated with retinal vein occlusion.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Known anticipated need for ocular surgery within next 12 months
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Diabetic retinopathy
- Uncontrolled systemic disease
- Known steroid-responder
- Use of systemic steroids
- Use of warfarin/heparin
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00168324
Start Date
October 1 2004
End Date
October 1 2008
Last Update
April 23 2019
Active Locations (13)
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1
Los Angeles, California, United States
2
Sydney, Australia
3
Graz, Austria
4
Halifax, Nova Scotia, Canada