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

Purpose

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.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: fluocinolone acetonide intravitreal implant	Phase II Phase III

MedlinePlus related topics:

Edema

ChemIDplus related topics:

Fluocinolone Fluocinolone acetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

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 ]

Enrollment:	196
Study Start Date:	September 2001
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

pregant, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502541

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators


Study Director:	Timothy L Comstock, OD	Bausch & Lomb, Inc.

More Information

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.

Study ID Numbers:	CDS FL-005
First Received:	July 13, 2007
Last Updated:	July 13, 2007
ClinicalTrials.gov Identifier:	NCT00502541
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Macular Edema

Fluocinolone Acetonide

Eye Diseases

Retinal Degeneration

Macular Degeneration

Edema

Retinal Diseases

Retinal degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Glucocorticoids

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00502541