Abstract
PURPOSE: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant is approved in the United Arab Emirates (UAE) for treating diabetic macular edema (DME) in patients previously treated with a course of corticosteroids and that did not have a clinically significant rise in intraocular pressure (IOP). This ongoing study is assessing its effectiveness and safety in pseudophakic patients with DME in clinical practice from a single center in the UAE. METHODS: A retrospective, ongoing 6-month audit study (NCT03590587), in which 22 eyes from 22 patients were treated with a single FAc intravitreal implant after treatment with a prior course of corticosteroids. Outcomes assessed included mean changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and IOP. Six-month follow-up data are presented. RESULTS: After FAc implantation, mean BCVA improved rapidly, increasing by 25.4 ± 3.0 letters (mean±SEM) from baseline to Month 6 (p<0.0001). At 6 months, BCVA had improved by 15 letters or more in 91% of eyes (n=20/22). Mean CMT decreased by 267.0 ± 20.1 µm from baseline to Month 6 (p<0.0001). Over 85% of eyes (n=19/22) had a CMT less than 300 µm at 6 months. Mean IOP increased by 2.9 ± 0.7 mmHg from baseline to Month 6 (p<0.001). All eyes except 2 had an IOP of 21 mmHg or lower. At Month 6, five eyes (23%) needed IOP-lowering therapy. CONCLUSION: Injection of the FAc intravitreal implant rapidly and significantly improved BCVA and CMT within 6 months. These rapid and significant improvements exceed those reported in other real-world studies. Safety signals were consistent with corticosteroid class effects. The FAc implant may be a useful treatment option for patients in the UAE, particularly those with sight threatening DME requiring rapid functional improvements.