Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
- Registration Number
- NCT00490815
- Lead Sponsor
- Alimera Sciences
- Brief Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- Age >= 18 years with diabetic macular edema
- Diagnosis of diabetes mellitus types 1 or 2
- Best corrected visual acuity of ≥ 19 letters
- Retinal thickness > 250 microns by OCT
- Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion Criteria
- 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 the last 3 months
- Prior intravitreal or subtenon anti-VEGF therapy within the last 2 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Fluocinolone Acetonide - 1 Fluocinolone Acetonide -
- Primary Outcome Measures
Name Time Method Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor over 36 months This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
- Secondary Outcome Measures
Name Time Method Retinal Thickness over 36 months
Trial Locations
- Locations (1)
John Hopkins University
🇺🇸Baltimore, Maryland, United States