Real-Life Results after the Administration of a Single 0.19 mg Fluocinolone Acetonide (ILUVIEN®) Implant in Patients with Refractory Diabetic Macular Edema

Ophthalmic Res. 2024;67(1):600-610. doi: 10.1159/000540459. Epub 2024 Aug 19.

Abstract

Introduction: The aim of this study was to evaluate real-life data on the functional and anatomical outcome of intravitreal fluocinolone acetonide (FAc) in patients with refractory diabetic macular edema (DME).

Methods: Retrospective study on 44 eyes with chronic DME that received intravitreal FAc implant and were previously treated with intravitreal dexamethasone, triamcinolone, or anti-vascular endothelial growth factor. We assessed best-corrected visual acuity (BCVA), central maximum thickness (CMT), and foveal thickness (FT) as measured by spectral-domain optical coherence tomography (Spectralis OCT; Heidelberg Engineering). Secondary outcomes were intraocular pressure (IOP), adverse events, time to additional treatments.

Results: The FAc implant significantly reduced the CMT (baseline 541.23 ± 155.29 µm, p < 0.001) and FT (baseline 460.34 ± 139.28 µm, p < 0.001) for up to 36 months. Despite postoperative visual improvement over time, BCVA did not significantly shift from baseline (0.55 ± 0.38 logMAR, p = 0.568). The FAc implant effect diminished after 21.34 ± 12.74 months. IOP increased in 9% of eyes (n = 4) but was well controlled under topical (n = 1) or surgical therapy (n = 3).

Conclusion: Even though patients' visual recovery does not benefit significantly, the FAc implant addresses the important pillars of chronic DME therapy regarding reduced injection frequency and reduced DME.

Keywords: 0.19 mg fluocinolone acetonide; Diabetic macular edema; ILUVIEN; IVOM.

MeSH terms

  • Aged
  • Diabetic Retinopathy* / complications
  • Diabetic Retinopathy* / diagnosis
  • Diabetic Retinopathy* / drug therapy
  • Diabetic Retinopathy* / physiopathology
  • Drug Implants*
  • Female
  • Fluocinolone Acetonide* / administration & dosage
  • Follow-Up Studies
  • Glucocorticoids* / administration & dosage
  • Humans
  • Intraocular Pressure / drug effects
  • Intraocular Pressure / physiology
  • Intravitreal Injections*
  • Macular Edema* / diagnosis
  • Macular Edema* / drug therapy
  • Macular Edema* / etiology
  • Male
  • Middle Aged
  • Retrospective Studies
  • Tomography, Optical Coherence* / methods
  • Treatment Outcome
  • Visual Acuity*

Substances

  • Fluocinolone Acetonide
  • Drug Implants
  • Glucocorticoids