Status:
COMPLETED
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Lead Sponsor:
Alimera Sciences
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
Eligibility Criteria
Inclusion
- Age \>= 18 years with diabetic macular edema
- Diagnosis of diabetes mellitus types 1 or 2
- Best corrected visual acuity of 19-68 letters
- Retinal thickness \> 250 micron by OCT
- Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion
- Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
- Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
- Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
- Any ocular surgery within the last 3 months
- Retinal laser treatment within the last 3 months
- History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
- Any lens opacity which impairs visualization of the posterior pole
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
956 Patients enrolled
Trial Details
Trial ID
NCT00344968
Start Date
September 1 2007
End Date
December 1 2010
Last Update
May 7 2014
Active Locations (1)
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1
Atlanta, Georgia, United States