Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Bausch & Lomb Incorporated278 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

278

Conditions

Noninfectious Posterior Uveitis

Interventions

fluocinolone acetonide intravitreal implantDRUG

Fluocinolone acetonide ocular implant 0.59mg

Fluocinolone acetonide 2.1mgDRUG

Fluocinolone acetonide ocular implant 2.1mg

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, and had 'quiet' eyes at surgery Exclusion Criteria: * Coexisting medical or ocular conditions that would interfere with the study results

Locations (1)

Duke Eye Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Recurrence of uveitis before and after implantation.

Time frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation

Secondary Outcomes

Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.