Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00456482

Purpose

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Condition	Intervention	Phase
Non-Infectious Uveitis	Drug: Fluocinolone Acetonide Intravitreal Implant	Phase II Phase III

Drug Information available for: Fluocinolone Fluocinolone acetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

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

Primary Outcome Measures:

Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.

Secondary Outcome Measures:

Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.

Estimated Enrollment:	250
Study Start Date:	May 2002
Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,
Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,
Had clinically ‘quiet’ eyes at surgery.

Exclusion Criteria:

Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456482

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:	415-004
Study First Received:	April 3, 2007
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00456482
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Fluocinolone Acetonide
Uveitis
Eye Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Uveal Diseases
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009