Clinical Trial: Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Posterior Uveitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Brief Summary: This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.

Detailed Summary:
Sponsor: pSivida Corp.

Current Primary Outcome: Recurrence of uveitis in study eye [ Time Frame: Six Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Recurrence of uveitis in study eye [ Time Frame: Three Years ]

Original Secondary Outcome: Same as current

Information By: pSivida Corp.

Dates:
Date Received: April 19, 2016
Date Started: June 2015
Date Completion: September 2019
Last Updated: December 22, 2016
Last Verified: December 2016