NCT00407082

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 278 (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 (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.

Conditions

• Noninfectious Posterior Uveitis

Interventions

Type	Name	Description
DRUG	fluocinolone acetonide intravitreal implant	Fluocinolone acetonide ocular implant 0.59mg
DRUG	Fluocinolone acetonide 2.1mg	Fluocinolone acetonide ocular implant 2.1mg

Timeline

• Start date: 2000-12-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2006-12-04
• Last updated: 2011-12-08

Locations

1 site across 1 country: United States