Real-World Clinical Outcomes After Sustained Delivery of the 0.19 mg Fluocinolone Acetonide Implant for Treatment of Diabetic Macular Edema

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.

Keywords: diabetic macular edema; diabetic retinopathy; fluocinolone acetonide; intraocular pressure; intravitreal implant; treatment burden.

Figure 1.

Visual acuity (VA) from baseline to at least 36 months after fluocinolone acetonide implantation. VA remained stable following treatment, with mean VA of 61.5 ± 1.5 ETDRS letters at baseline compared with 58.2 ± 0.3 ETDRS letters postimplantation (P = .034).

Figure 2.

Mean central subfield thickness (CST) at baseline and at the last recorded visit following fluocinolone acetonide implantation. Mean CST 1 month prior to implantation was 427.6 ± 20.8 µm and declined significantly 310.6 ± 11.4 µm (P < .001).

Figure 3.

Yearly treatment burden before and after fluocinolone acetonide implantation. The mean number of treatments was significantly reduced from 4.6 ± 0.95 preimplantation to 2.3 ± 0.25 postimplantation (P = .021).

Figure 4.

Intraocular pressure from 18 months prior to fluocinolone acetonide implantation through at least 36 months postimplantation. Mean intraocular pressure remained stable, with a baseline intraocular pressure of 15.8 mm Hg compared with 16.3 mm Hg postimplantation (P = .931). The red dashed line shows baseline at the time of first fluocinolone acetonide implantation.

Figure 5.

Retinal thickness variability before and after fluocinolone acetonide implantation. (A) Mean retinal thickness amplitude remained stable from 214.3 ± 15.9 µm preimplantation to 216.8 ± 17.9 µm postimplantation (P = .917). (B) Mean retinal thickness SD significantly decreased from 80.4 ± 5.8 µm preimplantation to 63.8 ± 4.6 µm postimplantation (P = .027). (C) Mean central subfield thickness area under the curve significantly declined from 351.1 ± 13.5 µm² preimplantation to 296.7 ± 10.9 µm² postimplantation (P = .002).