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

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Standard of care laser photocoagulation; Drug: Fluocinolone Acetonide

• Registration Number: NCT00344968
• Lead Sponsor: Alimera Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-26
• Study First Submitted QC: 2006-06-26
• Study First Posted: 2006-06-27
• Study Start: 2007-09
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Results First Submitted: 2013-09-27
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-08
• Last Update Submitted: 2014-04-08
• Results First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 956

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Standard of care laser photocoagulation	-
1	Fluocinolone Acetonide	-
2	Fluocinolone Acetonide	-

Primary Outcome Measures

Name	Time	Method
Visual Acuity	36 months	The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).

Secondary Outcome Measures

Name	Time	Method
Retinal Thickness	36 months	Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.