Purpose To determine the effect of an injectable fluocinolone acetonide implant (FAi) in eyes with noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Design Noncomparative, interventional, dose-randomized, dose-masked, prospective, individual, investigator-sponsored investigational new drug study. Participants Eleven eyes of 11 participants with a history of recurrent noninfectious intermediate uveitis, posterior, or panuveitis. Methods Participants were randomized to receive either a low- or a high-dose FAi. Eyes were observed on day 0 (day the implant was injected) and then at regular intervals through 2 years. Main Outcome Measures Ocular inflammation, visual acuity, anti-inflammatory medication use, and safety parameters before and after FAi implantation. Results All participants were followed up for 2 years. At baseline, mean study eye visual acuity was 0.56 logarithm of the minimum angle of resolution (logMAR; standard deviation [SD], 0.43 logMAR). These values improved significantly to +0.25 logMAR (SD, 0.14 logMAR) and +0.17 logMAR (SD, 0.14 logMAR) at 12 and 24 months after implantation, respectively (P = 0.041 and P = 0.016, respectively). The average number of inflammation recurrences in the 12 months before implantation was 1.54 episodes per eye. None of the study eyes experienced a recurrence during the follow-up period. Of the 6 participants who continued receiving systemic medication after implantation, the dosage was reduced in 4 participants. Five of 11 eyes received an average of 1.6 posterior sub-Tenon triamcinolone acetonide (PSTA) injections in the 12 months preceding implantation. None required a PSTA injection after FAi implantation. The most common adverse event was intraocular pressure (IOP) rise. At baseline, 1 study eye (9%) required pressure-lowering drops; 2 additional study eyes (18%) required them during the follow-up period. Filtering procedures were performed in 2 of these eyes (18.1%). No FAi explantations were required, nor were any participants lost to follow-up during the investigation. Conclusions It is feasible to place a long-acting FAi in an outpatient setting, without prolonged adverse events attributed to the implant injection procedure. The FAi effectively controlled intraocular inflammation in all eyes in the study, and at the last follow-up, all implanted eyes demonstrated an improvement in visual acuity. Elevated IOP that occurred in 18% of FAi-implanted eyes was managed by standard means. The FAi implant is a promising approach for patients with noninfectious intermediate uveitis, posterior uveitis, or panuveitis who do not respond to, or are intolerant to, conventional therapy.
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