Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema - Tabular View

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

February 26, 2009

Start Date ^ICMJE

September 2001

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: at 26 weeks and yearly through completion of the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 leakag [ Time Frame: at 26 weeks and yearly through completion of the study ]

Change History

Complete list of historical versions of study NCT00502541 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Official Title ^ICMJE

A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema

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

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Macular Edema

Intervention ^ICMJE

Drug: fluocinolone acetonide
Procedure: Standard of Care

Study Arms / Comparison Groups

Experimental: Fluocinolone acetonide intravitreal implant
Active Comparator: Standard of care

Publications *

Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. Epub 2006 May 9.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

196

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00502541

Responsible Party

Susan Schneider, MD, Bausch & Lomb Incorporated

Study ID Numbers ^ICMJE

CDS FL-005

Study Sponsor ^ICMJE

Bausch & Lomb, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Timothy L Comstock, OD

Bausch & Lomb, Inc.

Information Provided By

Bausch & Lomb, Inc.

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP