Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00456482
• Collaborator: (none)
• Enrollment: 239
• Arms: 3
• Duration (Months): 47

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Non-infectious Uveitis	Drug: Fluocinolone Acetonide 0.59mg; Drug: Fluocinolone Acetonide 2.1mg	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 239 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
• Study Start Date: May 1, 2002
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluocinolone Acetonide 0.59mg Fluocinolone acetonide intravitreal implant 0.59mg	Drug: Fluocinolone Acetonide 0.59mg; Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Experimental: Fluocinolone Acetonide 2.1mg Fluocinolone acetonide intravitreal implant 2.1mg	Drug: Fluocinolone Acetonide 2.1mg; Fluocinolone Acetonide Intravitreal Implant 2.1 mg
No Intervention: No Intervention Fellow eye

Outcome Measures

Primary Outcome Measures

1. 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. [1 year pre-implantation; 3 years post-implantation]

Secondary Outcome Measures

1. 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. [1 year pre-implantation; 3 years post-implantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Timothy L Comstock, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

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: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00456482
• Other Study ID Numbers: 415-004
• First Posted: Apr 5, 2007
• Last Update Posted: Dec 8, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Uveitis; Fluocinolone Acetonide

Study Results

No Results Posted as of Dec 8, 2011