Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Phase 2

Terminated

• Conditions: Non-infectious Uveitis
• Interventions: Drug: Fluocinolone Acetonide 0.59mg; Drug: Fluocinolone Acetonide 2.1mg

• Registration Number: NCT00456482
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-05
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 239

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluocinolone Acetonide 0.59mg	Fluocinolone Acetonide 0.59mg	Fluocinolone acetonide intravitreal implant 0.59mg
Fluocinolone Acetonide 2.1mg	Fluocinolone Acetonide 2.1mg	Fluocinolone acetonide intravitreal implant 2.1mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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