Overview

Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the 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 19-68 letters

- Retinal thickness > 250 micron 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 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