Overview
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Status:
Completed
Completed
Trial end date:
2011-04-01
2011-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edemaPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alimera SciencesTreatments:
Fluocinolone Acetonide
Criteria
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