Purpose: Evaluate the efficacy and safety of intravitreal 0.19 mg fluocinolone acetonide (FAc) micro implant in patients with chronic diabetic macular edema (cDME). Methods: Prospective study recruiting subjects with cDME. Inclusion criteria: cDME for at least 2 years documented with OCT imaging; pseudophakia; previous treatments with laser photocoagulation and intravitreal injections of anti-VEGF and/or dexamethasone. Exclusion criteria: phakia; ocular hypertension; tractional component visible on OCT; glaucoma; previous vitrectomy. Outcome measures included best-corrected visual acuity (BVCA), intraocular pressure (IOP), and central macular thickness (CMT), measured 1, 3, 6, and 12 months post-injection. Data were compared with the Friedman test and significance was set at p < 0.05. Results: A total of 18 eyes with a median duration of cDME of 45 months (25-118 months). The 77% of subjects either maintained or improved their BVCA. About 17% and 33% of subjects showed an improvement of 15 ETDRS letters or more at 3 and 12 months respectively. The 17% and 28% of subjects showed a CMT <250 microns at 3 and 12 months, respectively. The median change in CMT thickness was of -370 and -373.5 microns at 3 and 12 months post-injection respectively (p-value is 0.025). Changes in median IOP at 3 and 12 months post-injection were not statistically significant (p-value is 0.210). Ocular hypertension (OHT) was detected in two eyes (11%). Conclusion: The FAc micro implant has proved efficacy in improving and/or maintaining BVCA in 77% of patients with cDME up to 12 months post-injection. Ocular hypertension is the most common side effect but responds well to topical therapy.

Efficacy and safety of intravitreal fluocinolone acetonide microimplant (ILUVIEN®) in patients with chronic diabetic macular edema: 1 year follow-up / Pacella, Fernanda; Pacella, Elena; Trovato Battagliola, Edoardo; Malvasi, Mariaelena; Scalinci, Sergio Zaccaria; Turchetti, Paolo; Salducci, Mauro; Lucchino, Luca; Arrico, Loredana. - In: EUROPEAN JOURNAL OF OPHTHALMOLOGY. - ISSN 1120-6721. - 32:2(2022), pp. 1109-1113. [10.1177/11206721211020203]

Efficacy and safety of intravitreal fluocinolone acetonide microimplant (ILUVIEN®) in patients with chronic diabetic macular edema: 1 year follow-up

Pacella, Fernanda
Primo
;
Pacella, Elena
Secondo
;
Trovato Battagliola, Edoardo;Malvasi, Mariaelena;Turchetti, Paolo;Salducci, Mauro;Lucchino, Luca
Penultimo
;
Arrico, Loredana
Ultimo
2022

Abstract

Purpose: Evaluate the efficacy and safety of intravitreal 0.19 mg fluocinolone acetonide (FAc) micro implant in patients with chronic diabetic macular edema (cDME). Methods: Prospective study recruiting subjects with cDME. Inclusion criteria: cDME for at least 2 years documented with OCT imaging; pseudophakia; previous treatments with laser photocoagulation and intravitreal injections of anti-VEGF and/or dexamethasone. Exclusion criteria: phakia; ocular hypertension; tractional component visible on OCT; glaucoma; previous vitrectomy. Outcome measures included best-corrected visual acuity (BVCA), intraocular pressure (IOP), and central macular thickness (CMT), measured 1, 3, 6, and 12 months post-injection. Data were compared with the Friedman test and significance was set at p < 0.05. Results: A total of 18 eyes with a median duration of cDME of 45 months (25-118 months). The 77% of subjects either maintained or improved their BVCA. About 17% and 33% of subjects showed an improvement of 15 ETDRS letters or more at 3 and 12 months respectively. The 17% and 28% of subjects showed a CMT <250 microns at 3 and 12 months, respectively. The median change in CMT thickness was of -370 and -373.5 microns at 3 and 12 months post-injection respectively (p-value is 0.025). Changes in median IOP at 3 and 12 months post-injection were not statistically significant (p-value is 0.210). Ocular hypertension (OHT) was detected in two eyes (11%). Conclusion: The FAc micro implant has proved efficacy in improving and/or maintaining BVCA in 77% of patients with cDME up to 12 months post-injection. Ocular hypertension is the most common side effect but responds well to topical therapy.
2022
DME; Iluvien; intravitreal; chronic diabetic macular edema; diabetic retinopathy; fluocinolone acetonide
01 Pubblicazione su rivista::01a Articolo in rivista
Efficacy and safety of intravitreal fluocinolone acetonide microimplant (ILUVIEN®) in patients with chronic diabetic macular edema: 1 year follow-up / Pacella, Fernanda; Pacella, Elena; Trovato Battagliola, Edoardo; Malvasi, Mariaelena; Scalinci, Sergio Zaccaria; Turchetti, Paolo; Salducci, Mauro; Lucchino, Luca; Arrico, Loredana. - In: EUROPEAN JOURNAL OF OPHTHALMOLOGY. - ISSN 1120-6721. - 32:2(2022), pp. 1109-1113. [10.1177/11206721211020203]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1549081
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