Real-world experience with fluocinolone acetonide intravitreal implant in patients with diabetic macular edema.

Autor:	Capone L; Department of Ophthalmology, IRCCS San Raffaele Scientific Institute-School of Medicine, Vita-Salute San Raffaele University Milan, Milano, Italy., Airaghi P; Ophthalmology Unit, IRCCS S. Gerardo dei Tintori, Monza, Italy., Aragona P; Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy., Castellino N; Department of Ophthalmology, University of Catania, Catania, Italy., Cicinelli MV; Department of Ophthalmology, IRCCS San Raffaele Scientific Institute-School of Medicine, Vita-Salute San Raffaele University Milan, Milano, Italy., Ciucci F; Ophthalmology Unit, San Pietro Fatebenefratelli Hospital, Rome, Italy., Coppola M; Ophthalmology Unit, IRCCS S. Gerardo dei Tintori, Monza, Italy., Gaetano C; Ophthalmology Unit, San Pietro Fatebenefratelli Hospital, Rome, Italy., Lattanzio R; Department of Ophthalmology, IRCCS San Raffaele Scientific Institute-School of Medicine, Vita-Salute San Raffaele University Milan, Milano, Italy., Lorusso M; Department of Ophthalmology, Ente Ecclesiastico F. Miulli Hospital, Bari, Italy., Maceroni M; Institute of Ophthalmology, Università Cattolica del Sacro Cuore-Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy., Malvasi ME; Department of Sense Organs, Sapienza University of Rome, Rome, Italy., Marco L; Medical Affairs, SIFI SpA, Catania, Italy., Marraffa M; Department of Ophthalmology, ULSS 9 Scaligera, Orlandi Hospital, Bussolengo, Verona, Italy., Martini G; Department of Ophthalmology, ULSS 9 Scaligera, Orlandi Hospital, Bussolengo, Verona, Italy., Mastropasqua R; Ophthalmology Clinic, Department of Medicine and Science of Ageing, University G. D'Annunzio Chieti-Pescara, Chieti, Italy., Minnella AM; Institute of Ophthalmology, Università Cattolica del Sacro Cuore-Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy., Nikolopulou E; Department of Ophthalmology, Ente Ecclesiastico F. Miulli Hospital, Bari, Italy., Ortisi E; Department of Ophthalmology, University of Catania, Catania, Italy., Pacella E; Department of Sense Organs, Sapienza University of Rome, Rome, Italy., Papa V; Medical Affairs, SIFI SpA, Catania, Italy., Pennesi C; Ophthalmology Unit, IRCCS S. Gerardo dei Tintori, Monza, Italy., Reibaldi M; Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy., Rizzo S; Institute of Ophthalmology, Università Cattolica del Sacro Cuore-Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy., Toto L; Ophthalmology Clinic, Department of Medicine and Science of Ageing, University G. D'Annunzio Chieti-Pescara, Chieti, Italy., Trombetta L; Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy., Bandello F; Department of Ophthalmology, IRCCS San Raffaele Scientific Institute-School of Medicine, Vita-Salute San Raffaele University Milan, Milano, Italy.
Jazyk:	angličtina
Zdroj:	European journal of ophthalmology [Eur J Ophthalmol] 2024 Nov; Vol. 34 (6), pp. 1837-1842. Date of Electronic Publication: 2024 Feb 23.
DOI:	10.1177/11206721241235266
Abstrakt:	Objectives: to evaluate long-term effectiveness and safety of fluocinolone acetonide (FAc) implant used as second-line treatment in patients with persistent diabetic macular edema (DME). Methods: retrospective data chart review of 241 pseudophakic eyes of 178 patients treated with FAc from July 2017 to December 2021 in 10 medical retinal units in Italy. The primary endpoint was the change of best-corrected visual acuity (BCVA) and central macular thickness (CMT) at 2 years. A Student's paired t-test was used. Additional therapies for DME and intraocular pressure (IOP)-related events were also evaluated. Results: efficacy of FAc was assessed in a subset of 111 eyes with at least 24 months of follow-up. Mean BCVA increased at 2 years by 5.1 ETDRS letters (95%CI = 2.6-7.5; p  < 0.001) while mean CMT decreased by 189 µm (95% CI 151-227; p  < 0.001). Thirty-eight of these eyes (34.2%) needed additional intravitreal treatments, mainly anti-VEGF. Safety was evaluated on the entire cohort of 241 eyes treated with FAc. Overall, 66 eyes (27.4%) required emergent IOP-lowering medications (typically within the first-year post FAc) while 14 eyes (5.8%) underwent trabeculectomy, mostly during the second year of follow-up. Conclusion: FAc implant provides a substantial long-term functional and anatomical benefit when used as second-line treatment in eyes with DME. IOP rise can be adequately managed with topical agents although some eyes may require IOP-lowering surgery. Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
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