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

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

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 Procedure: Standard of Care	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Fluocinolone acetonide

U.S. FDA Resources

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

Enrollment:	196
Study Start Date:	September 2001
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluocinolone acetonide Fluocinolone acetonide intravitreal implant	Drug: fluocinolone acetonide fluocinolone acetonide 0.59 mg intravitreal implant
Active Comparator: Standard of Care Standard of care	Procedure: Standard of Care Repeat macular grid laser or observation

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:

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

Contacts and Locations

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

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Laura Trusso

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.

Responsible Party:	Tuyen Ong, MD, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00502541 History of Changes
Obsolete Identifiers:	NCT00031525
Other Study ID Numbers:	CDS FL-005
Study First Received:	July 13, 2007
Last Updated:	October 8, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2012