Real-World Evidence of the Long-Term Effectiveness of 0.2 μg/Day Fluocinolone Acetonide Implant in Persistent and Recurrent Diabetic Macular Edema – A Single Center Study

Purpose: To report the long-term functional, anatomical and safety outcomes of 0.2 μg/day fluocinolone acetonide 0.19mg in patients with persistent or recurrent diabetic macular edema (DME). Methods: Retrospective, observational, single-center study of patients with recurrent or persistent DME. All patients received 0.2 μg/day of fluocinolone acetonide 0.19mg, and data were collected at baseline and months 1, 3, 6, 12, 24 and 36 after implantation. Outcomes measured included best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and safety outcomes. Results: A total of 28 eyes from 28 patients were included. The mean age was 66.5 years (95% CI 62.8– 70.2) with a mean duration of DME of 8.8 years (95% CI 7.7– 10.0). Only two eyes were phakic. Mean follow-up was 25.4 months (95% CI 21.2– 29.6). Mean BCVA at baseline was 48.6 ETDRS letters (95% CI 41.3– 55.8) and improved as early as month 1 of follow-up with a mean gain in BCVA of 7.8 (95% CI 4.3– 11.3) ETDRS letters (p< 0.001). Statistically significant improvements in BCVA were also observed at months 6, 12 and 24. At baseline, patients had a mean CMT of 530.5μm (95% CI 463.0– 598.0), and a decrease in CMT was observed, starting at the first month of follow-up (mean CMT reduction of − 170.5μm, 95% CI − 223.8– − 117.1; p< 0.001). Statistically significant decreases in CMT were also observed at months 6, 12, 24, and 36, with the maximum decrease observed at month 12 (p< 0.001). Mean IOP at baseline was 16.4mmHg (95% CI 15.3– 17.5) and nine eyes (32.1%) had an IOP ≥ 21mmHg during follow-up. Conclusion: Our results support the effectiveness and safety profile of fluocinolone acetonide. Although additional long-term real-world evidence is required, fluocinolone acetonide may represent a safe strategy for daily, low-dose, sustained and localized release to the posterior segment of the eye, providing both functional and anatomical benefits in DME.