Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

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.