Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
NCT00490815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2014-02-13
Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Conditions
Interventions
- DRUG
-
Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
- DRUG
-
Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert
Sponsors & Collaborators
-
Alimera Sciences
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2009-09-30
- Completion
- 2011-04-30
Countries
- United States
Study Locations
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