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

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

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

Key facts

Study ID

NCT00344968

Run by

Alimera Sciences

People needed

956

Starts

2007-09-01

Expected to finish

2010-12-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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