Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Phase 2

Completed

• Conditions: Noninfectious Posterior Uveitis
• Interventions: Drug: fluocinolone acetonide intravitreal implant; Drug: Fluocinolone acetonide 2.1mg

• Registration Number: NCT00407082
• 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 (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2006-12-01
• Study First Submitted QC: 2006-12-01
• Study First Posted: 2006-12-04
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluocinolone acetonide 0.59mg	fluocinolone acetonide intravitreal implant	Fluocinolone acetonide ocular implant 0.59mg
Fluocinolone acetonide 2.1mg	Fluocinolone acetonide 2.1mg	Fluocinolone acetonide ocular implant 2.1mg

Primary Outcome Measures

Name	Time	Method
Recurrence of uveitis before and after implantation.	34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation

Secondary Outcome Measures

Name	Time	Method
Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.	34 weeks, 1 year, 2 years and 3 years post-implantation
Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.	34 weeks, 1 year, 2 years and 3 years post-implantation
The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)	34 weeks, 1 year, 2 years and 3 years post-implantation
Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)	34 weeks, 1 year, 2 years and 3 years post-implantation
Results of QOL surveys pre- versus post-implantation	34 weeks, 1 year, 2 years and 3 years post-implantation
Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)	34 weeks, 1 year, 2 years and 3 years post-implantation
Time to recurrence, between treatment group comparison	34 weeks, 1 year, 2 years and 3 years post-implantation
Post implantation uveitis rate, between treatment group comparison	34 weeks, 1 year, 2 years and 3 years post-implantation

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States