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

• Published in: Ophthalmic research Vol. 67; no. 1; pp. 600 - 610
• Main Authors: Darwisch, Warda, della Volpe-Waizel, Maria, Roberts, Philipp K., Boden, Karl T., Szurman, Peter, Rickmann, Annekatrin
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland S. Karger AG 01.01.2024
• Subjects: Aged; Corticosteroids; Diabetic Retinopathy - complications; Diabetic Retinopathy - diagnosis; Diabetic Retinopathy - drug therapy; Diabetic Retinopathy - physiopathology; Diabetics; Dropsy; Drug Implants; Edema; Female; Fluocinolone; Fluocinolone acetonide; 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; Patient compliance; Research Article; Retrospective Studies; Tomography, Optical Coherence - methods; Treatment Outcome; Triamcinolone; Vascular endothelial growth factor; Visual Acuity; South Dakota; Virginia; Germany; 0.19 mg fluocinolone acetonide; IVOM; ILUVIEN; Diabetic macular edema
• ISSN: 0030-3747; 1423-0259; 1423-0259
• DOI: 10.1159/000540459

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.