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Introduction <p>This study aimed to evaluate the long-term efficacy and safety of the 0.19&#xa0;mg fluocinolone acetonide (FAc) intravitreal implant in patients with refractory diabetic macular edema (DME).</p> Methods <p>In this retrospective single-center study, patients with refractory DME treated with the 0.19&#xa0;mg FAc implant (Iluvien<sup>®</sup>, Alimera Sciences) between January 2016 and November 2024 were included. Primary outcomes were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to the last follow-up visit.</p> Results <p>In total, 49 eyes from 39 patients (mean age 70.4 ± 9.8&#xa0;years) were analyzed. All eyes had previously received anti-vascular endothelial growth factor (anti-VEGF) agents and/or short-acting intravitreal corticosteroids, and 47 (95.9%) had undergone laser photocoagulation. Mean follow-up was 23.9 ± 11.4&#xa0;months. Mean CRT decreased from 502.1 ± 154.0&#xa0;µm to 325.6 ± 102.9&#xa0;µm (mean change –176.5 ± 114.8&#xa0;µm; <i>p</i> &lt; 0.0001). CRT reductions ≥ 20% and ≥ 30% occurred in 87.8% and 49.0% of eyes, respectively, and 55.1% achieved CRT ≤ 300&#xa0;µm. Mean BCVA improved from 47.3 ± 18.2 to 54.9 ± 14.7 letters (mean gain 7.6 ± 11.2 letters; <i>p</i> &lt; 0.0001). Transient intraocular pressure (IOP) elevation occurred in 38.8% of eyes, with one case requiring surgery. Additional DME treatment was required in 26.5% of eyes.</p> Conclusions <p>These findings suggest that the FAc implant provides sustained anatomical and visual benefits with a manageable safety profile in chronic refractory DME.</p>

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Efficacy and Safety Outcomes of Fluocinolone Acetonide Intravitreal Implant in Refractory Diabetic Macular Edema: A Real-World Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月2日

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  • João Castro Cabanas,
  • Daniel Ferreira Cardoso,
  • Catarina Cunha Ferreira,
  • Carolina Madeira,
  • Eduardo Saraiva,
  • Lígia Ribeiro,
  • Sofia Fonseca,
  • Luís M. A. Silva,
  • Filipe Sousa-Neves

摘要

Introduction

This study aimed to evaluate the long-term efficacy and safety of the 0.19 mg fluocinolone acetonide (FAc) intravitreal implant in patients with refractory diabetic macular edema (DME).

Methods

In this retrospective single-center study, patients with refractory DME treated with the 0.19 mg FAc implant (Iluvien®, Alimera Sciences) between January 2016 and November 2024 were included. Primary outcomes were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to the last follow-up visit.

Results

In total, 49 eyes from 39 patients (mean age 70.4 ± 9.8 years) were analyzed. All eyes had previously received anti-vascular endothelial growth factor (anti-VEGF) agents and/or short-acting intravitreal corticosteroids, and 47 (95.9%) had undergone laser photocoagulation. Mean follow-up was 23.9 ± 11.4 months. Mean CRT decreased from 502.1 ± 154.0 µm to 325.6 ± 102.9 µm (mean change –176.5 ± 114.8 µm; p < 0.0001). CRT reductions ≥ 20% and ≥ 30% occurred in 87.8% and 49.0% of eyes, respectively, and 55.1% achieved CRT ≤ 300 µm. Mean BCVA improved from 47.3 ± 18.2 to 54.9 ± 14.7 letters (mean gain 7.6 ± 11.2 letters; p < 0.0001). Transient intraocular pressure (IOP) elevation occurred in 38.8% of eyes, with one case requiring surgery. Additional DME treatment was required in 26.5% of eyes.

Conclusions

These findings suggest that the FAc implant provides sustained anatomical and visual benefits with a manageable safety profile in chronic refractory DME.