NCT00456482

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-infectious Uveitis

Interventions

Type	Name	Description
DRUG	Fluocinolone Acetonide 0.59mg	Fluocinolone Acetonide Intravitreal Implant 0.59 mg
DRUG	Fluocinolone Acetonide 2.1mg	Fluocinolone Acetonide Intravitreal Implant 2.1 mg

Timeline

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