Abstract
PURPOSE: To evaluate the real-world safety and efficacy of the 0.19 mg fluocinolone acetonide intravitreal implant for the management of diabetic macular edema (DME). METHODS: This retrospective study included 94 eyes from 58 patients, of whom all but 1 had type 2 diabetes. The mean age (± SD) was 75.5 ± 2.12 years. Each patient received at least 1 fluocinolone acetonide implant after a corticosteroid trial without significant intraocular pressure elevation. Data were collected from visits up to 18 months preimplantation (mean, 14.6 months) and 3 years postimplantation (mean, 51 months). Key outcomes included central subfield thickness (CST), visual acuity (VA), intraocular pressure, retinal thickness variability measures, and treatment frequency. RESULTS: Mean baseline VA remained stable, decreasing from 61.5 ± 1.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters preimplantation to 58.2 ± 0.3 ETDRS letters postimplantation (P = .034). Mean CST decreased significantly from 427.6 ± 20.8 µm 1 month preimplantation to 310.6 ± 11.4 µm at final follow-up (P < .001). Annual treatment frequency dropped significantly from 4.6 ± 0.95 injections preimplantation to 2.3 ± 0.25 injections postimplantation (P = .021). Retinal thickness variability improved significantly (80.4 ± 5.8 µm to 63.8 ± 4.6 µm; P = .027), with a corresponding CST area under the curve (351.1 ± 13.5 µm² to 296.7 ± 10.9 µm²; P = .002). Intraocular pressure remained stable, increasing slightly from 15.8 mmHg to 16.3 mmHg. No new safety signals were observed. CONCLUSIONS: The fluocinolone acetonide implant demonstrated sustained visual stability, significant anatomical improvement, reduced treatment burden, and a manageable safety profile. These findings support its role as an effective long-term therapeutic option for DME, including in vitrectomized eyes.