Treatment of posterior uveitis with a fluocinolone acetonide implant: Three-year clinical trial results

Objectives: To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious posterior uveitis. Design: A 3-year, multicenter, randomized, historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients. Main Outcome Measures: Recurrence rate, vision, and complications. Results: Uveitis recurrence was reduced in implanted eyes from 62% (during the 1-year preimplantation period) to 4%, 10%, and 20% during the 1-, 2-, and 3-year postimplantation periods, respectively, for the 0.59-mg dose group (P<.01) and from 58% to 7%, 17%, and 41%, respectively, for the 2.1-mg dose group (P<.01). More implanted eyes than nonimplanted eyes had improved visual acuity (P<.01). Implanted eyes had higher incidences of intraocular pressure elevation (≥10 mm Hg) than nonimplanted eyes (P<.01), and glaucoma surgery was required in 40% of implanted eyes vs 2% of non-implanted eyes (P<.01). Cataracts were extracted in 93% of phakic implanted eyes vs 20% of phakic nonimplanted eyes (P<.01). Conclusions: The FA implant significantly reduced uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious posterior uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure-lowering surgery. Application to Clinical Practice: The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis. Trial Registration: clinicaltrials.gov Identifier: NCT00407082.