Real-life results after the administration of a single 0.19 mg fluocinolone acetonide (ILUVIEN®) implant in patients with refractory diabetic macular edema.

Introduction: 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-VEGF. 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 < .001) and FT (baseline 460.34 ± 139.28 µm, p < .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 = .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.