Purpose: To compare Iluvien intravitreal inserts that release 0.2 or 0.5 μg/day of fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). Design: Prospective, randomized, interventional, multicenter clinical trial. Participants: We included 37 patients with DME. Methods: Subjects with persistent DME despite ≥1 focal/grid laser therapy were randomized 1:1 to receive an intravitreal insertion of a 0.2- or a 0.5-μg/day insert. Main Outcome Measures: The primary end point was aqueous levels of FA throughout the study with an important secondary outcome of the change from baseline in best-corrected visual acuity (BCVA) at month 12. Results: The mean aqueous level of FA peaked at 3.8 ng/ml at 1 week and 1 month after administration of a 0.5-μg/day insert and was 3.4 and 2.7 ng/ml 1 week and 1 month after administration of a 0.2-μg/day insert. For both inserts, FA levels decreased slowly thereafter and were approximately 1.5 ng/ml for each at month 12. The mean change from baseline in BCVA was 7.5, 6.9, and 5.7 letters at months 3, 6, and 12, respectively, after administration of a 0.5μg/day-insert and was 5.1, 2.7, and 1.3 letters at months 3, 6, and 12, respectively, after administration of a 0.2-μg/day insert. There was a mild increase in mean intraocular pressure after administration of 0.5-μg/day inserts, but not after administration of 0.2-μg/day inserts. Conclusions: The FA intravitreal inserts provide excellent sustained intraocular release of FA for ≥1 year. Although the number of patients in this trial was small, the data suggest that the inserts provide reduction of edema and improvement in BCVA in patients with DME with mild effects on intraocular pressure over the span of 1 year.
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