Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Bausch + Lomb

Status and phase: Completed; Phase 3; Phase 2

Conditions: Noninfectious Posterior Uveitis

Treatments: Drug: fluocinolone acetonide intravitreal implant; Drug: Fluocinolone acetonide 2.1mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407082

415-001

Details and patient eligibility

About

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.

Enrollment: 278 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

278 participants in 3 patient groups

Fluocinolone acetonide 0.59mg

Experimental group

Description:

Fluocinolone acetonide ocular implant 0.59mg

Treatment:

Drug: fluocinolone acetonide intravitreal implant

Fluocinolone acetonide 2.1mg

Experimental group

Description:

Fluocinolone acetonide ocular implant 2.1mg

Treatment:

Drug: Fluocinolone acetonide 2.1mg

No intervention

No Intervention group

Description:

Fellow eye