Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
ClinicalTrials.gov ID
NCT00799227
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
56Actual
Last Update Posted
Apr 23, 2019Actual
Start Date
Jan 1, 2009Actual
Primary Completion Date
Dec 1, 2009Actual
Completion Date
Dec 1, 2009Actual
Brief 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.
Diabetic Macular Edema
Vitrectomy
Dexamethasone
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
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