Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis.
PURPOSE: To investigate the safety and efficacy of a fluocinolone acetonide intravitreal implant in the treatment of noninfectious posterior uveitis. DESIGN: Noncomparative interventional case series, dose randomized, dose masked, prospective. PARTICIPANTS: Thirty-six eyes of 32 patients with a history of recurrent noninfectious posterior uveitis. METHODS: Patients were randomized to receive either a 0.59-mg or a 2.1-mg fluocinolone acetonide intravitreal implant. Patients were observed every 4 to 6 weeks for the first 3 months and then every 3 months thereafter. MAIN OUTCOME MEASURES: Preoperative and postoperative ocular inflammation, visual acuity (VA), antiinflammatory medication use, and safety. RESULTS: Mean follow-up duration was 683+/-461 days (range, 204-1817). Mean baseline visual acuity for the device-implanted eyes was +1.1 logarithm of the minimum angle of resolution (logMAR) units (20/250), which improved significantly to +0.81 logMAR units (20/125) at 30 months (P<0.05). Inflammation was effectively controlled over the follow-up period. The average number of recurrences in the 12 months before implantation was 2.5 episodes per eye. None of these eyes experienced a recurrence for the first 2 years after implantation. There was a reduction in systemic and local therapy use in the device-implanted eyes; of the patients who remained on systemic medication after implantation, dosage was reduced in 68%. The posterior sub-Tenon's capsule injection rate significantly decreased from a mean of 2.2 injections per eye per year to 0.07 injections per eye per year (P<0.0001) The most common adverse event was intraocular pressure (IOP) rise. At baseline, 11.0% of eyes used pressure-lowering agents, versus 56.1% over the follow-up period (P = 0.005). Filtering procedures were performed in 7 (19.4%) eyes. Four of the 8 phakic eyes, each of which had some level of cataract at device implantation, subsequently underwent cataract extraction. There were no device explantations or patients lost to follow-up during the investigation. CONCLUSION: The fluocinolone acetonide intravitreal implant effectively controlled intraocular inflammation in the studied population. Elevated IOP and cataracts that occurred in fluocinolone device-implanted eyes were managed by standard means. The fluocinolone acetonide sustained drug delivery implant seems to be promising in patients with posterior uveitis who do not respond to or are intolerant to conventional treatment.
Jaffe, GJ; McCallum, RM; Branchaud, B; Skalak, C; Butuner, Z; Ashton, P
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