Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alimera Sciences
• Treatments: 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