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

Sponsor:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00407082

Purpose

This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) 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
Noninfectious Posterior Uveitis	Drug: fluocinolone acetonide intravitreal implant Drug: Fluocinolone acetonide	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Historical Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Resource links provided by NLM:

Drug Information available for: Fluocinolone acetonide Fluocinolone

U.S. FDA Resources

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

Primary Outcome Measures:

Recurrence of uveitis before and after implantation. [ Time Frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Results of QOL surveys pre- versus post-implantation [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Time to recurrence, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]
Post implantation uveitis rate, between treatment group comparison [ Time Frame: 34 weeks, 1 year, 2 years and 3 years post-implantation ] [ Designated as safety issue: No ]

Enrollment:	278
Study Start Date:	December 2000
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fluocinolone acetonide implant 0.59mg	Drug: fluocinolone acetonide intravitreal implant Fluocinolone acetonide implant 0.59mg
2: Experimental Fluocinolone acetonide implant 2.1mg	Drug: Fluocinolone acetonide Fluocinolone acetonide implant 2.1mg
3: No Intervention Fellow eye

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, and had 'quiet' eyes at surgery

Exclusion Criteria:

Coexisting medical or ocular conditions that would interfere with the study results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407082

Locations

United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Thomas A Crescuillo

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201.

Responsible Party:	Bausch & Lomb Incorporated ( Timothy Comstock )
Study ID Numbers:	415-001
Study First Received:	December 1, 2006
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00407082 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Panuveitis
Anti-Inflammatory Agents
Uveal Diseases
Uveitis, Posterior
Fluocinolone Acetonide
Eye Diseases
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Glucocorticoids
Hormones
Pharmacologic Actions
Uveitis
Therapeutic Uses

ClinicalTrials.gov processed this record on March 18, 2010