Clinical Trial: Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

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

Official Title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Aff

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 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: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: recurrence of uveitis in the study eye [ Time Frame: three years ]

Original Secondary Outcome: Same as current

Information By: pSivida Corp.

Dates:
Date Received: September 24, 2012
Date Started: June 2013
Date Completion: March 2018
Last Updated: December 22, 2016
Last Verified: December 2016