Overview

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
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

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

- Diabetic retinopathy

- Uncontrolled systemic disease

- Known steroid-responder

- Use of systemic steroids

- Use of warfarin/heparin