Effectiveness and tolerability of the fluocinolone acetonide implant in patients with diabetic macular edema in UAE: 12-Month results

Abstract

Introduction: To evaluate 12-month outcomes following fluocinolone acetonide (FAc 0.2 μg/day) implant in pseudophakic patients with diabetic macular edema (DME) that persists or recurs despite previous treatment with anti-vascular endothelial growth factors (anti-VEGF) and dexamethasone implant (DEX) in a UAE population. Methods: A retrospective, observational, single-center, 12-month audit study, where 22 pseudophakic eyes (22 patients) with DME were treated with the FAc intravitreal implant according to licensed UAE indications. Outcome measurements at baseline and at months 1, 3, 6, and 12 included best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results: Post-FAc implantation, mean BCVA significantly improved at 1, 3, and 12 months (+10.4 ± 16.1, +22.8 ± 13.6, and +25.5 ± 13.0 letters, respectively; p < 0.0001), with 86% of eyes gaining ⩾15 letters at month 12. Similarly, CMT reduced significantly at month 1, and stabilized thereafter at months 3–12 (−171.5 ± 72.5 µm, −240.9 ± 74.2 µm, and −246.2 ± 93.4 µm, respectively; p < 0.0001). By month 12, 64% ( n = 14/22) of eyes had a CMT below 300 µm. Only 1 eye had an IOP ⩾ 21 mmHg at baseline and month 12. Five eyes required IOP lowering drops and 1 required IOP-lowering surgical intervention. Conclusion: In pseudophakic patients with DME FAc implant provide a substantial functional and anatomical benefits for up to 12 months.