NCT00468871

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.

Conditions

• Non-infectious Uveitis

Interventions

Type	Name	Description
DRUG	fluocinolone acetonide intravitreal implant	surgical intravitreal implant of fluocinolone acetonide
DRUG	corticosteroids and immunosuppressants	Systemic corticosteroids alone or combined with immunosuppressants

Timeline

• Start date: 2002-04-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2007-05-03
• Last updated: 2011-12-08