Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.

Inclusion Criteria:

• Males and non-pregnant females at least 6 years of age
• History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
• The more severely affected eye having had at least 2 separate recurrences
• The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion
• Visual acuity (VA) of at least 1.4 logMAR units at enrollment
• At time of enrollment, </=10 anterior chamber cells/HPF and vitrous haze</= grade 2.

Exclusion Criteria:

• known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
• history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
• presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP >25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to <25 mm Hg
• history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
• infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
• ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment
• monocularity
• AIDS
• pregnancy/lactation
• potential for noncompliance
• or participation in other clinical studies within 1 month of enrollment.