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

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Fluocinolone Acetonide

• Registration Number: NCT00490815
• Lead Sponsor: Alimera Sciences

Brief Summary

This study will evaluate the pharmacokinetics, 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: 2007-06-21
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-25
• Study Start: 2007-08
• Primary Completion: 2009-09
• Study Completion: 2011-04
• Results First Submitted: 2013-09-27
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-17
• Last Update Submitted: 2014-01-17
• Results First Posted: 2014-02-13
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Fluocinolone Acetonide	-
1	Fluocinolone Acetonide	-

Primary Outcome Measures

Name	Time	Method
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor	over 36 months	This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.

Secondary Outcome Measures

Name	Time	Method
Retinal Thickness	over 36 months

Trial Locations

Locations (1)

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States