advertisement
Abstract #95455 Published in IGR 22-2
Efficacy and safety of intravitreal Fluocinolone Acetonide microimplant (ILUVIEN) in patients with chronic diabetic macular edema: 1 year follow-up
Pacella F; Pacella E; Trovato Battagliola E; Malvasi M; Scalinci SZ; Turchetti P; Salducci M; Lucchino L; Arrico LEuropean Journal of Ophthalmology 2021; 0: 11206721211020203
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 < 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 (-value is 0.025). Changes in median IOP at 3 and 12 months post-injection were not statistically significant (-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.
Department of Sense Organs, La Sapienza University of Rome, Rome, Italy.
Full article