Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Standard of Care; Drug: fluocinolone acetonide

• Registration Number: NCT00502541
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-17
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Males and nonpregnant females at least 18 years of age, with DME in the study eye
• Edema must involve fixation and be at least 1 disc area in size
• Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye
• The study eye must have received at least one macular laser treatment > 12 weeks prior to entry into the study
• Ability and willingness to comply with treatment and follow-up
• Ability to understand and sign the Informed Consent form

Exclusion Criteria

• Pregnant, lactating females
• Allergy to fluocinolone acetonide or any component of the delivery system
• Any disease or condition that would preclude study treatment or follow up
• Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).
• History of uncontrolled IOP within the last 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard of care
Fluocinolone acetonide	fluocinolone acetonide	Fluocinolone acetonide intravitreal implant

Primary Outcome Measures

Name	Time	Method
A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage	at 26 weeks and yearly through completion of the study