Overview
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Status:
Completed
Completed
Trial end date:
2009-12-01
2009-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AllerganTreatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
Inclusion Criteria:- 18 years of age or older with diabetic macular edema
- History of vitrectomy
- Central retinal thickness ≥ 275 µm
- Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in
the other eye
Exclusion Criteria:
- Known anticipated need for ocular surgery during the study period
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Uncontrolled systemic disease
- Known allergy to the study medication
- Known steroid-responder
- Use of systemic steroids
- Female subjects that are pregnant, nursing or planning a pregnancy