Status:
COMPLETED
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Lead Sponsor:
Allergan
Conditions:
Diabetic Macular Edema
Vitrectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00799227
Start Date
January 1 2009
End Date
December 1 2009
Last Update
April 23 2019
Active Locations (2)
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1
Charlotte, North Carolina, United States
2
Sydney, New South Wales, Australia