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

Abstract

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.

Keywords:

• diabetic macular edema
• intravitreal implant
• best corrected visual acuity
• intravitreal corticosteroid
• sub-optimal response

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

There is no funding to report.