Efficacy and safety of intravitreal Fluocinolone Acetonide micro implant (ILUVIEN®) in patients with chronic diabetic macular edema: one-year follow-up.

Purpose : evaluate the efficacy and safety of intravitreal 0.19 mg fluocinolone acetonide (FAc) micro implant (ILUVIEN®) in patients with chronic diabetic macular edema (cDME). This is defined as edema that persists or recurs despite treatment. Methods : observational prospective study recruiting subjects with cDME. Inclusion criteria: cDME for at least 2 years documented with OCT imaging, pseudophakia, previous treatments with laser photocoagulation, intravitreal injections of anti-VEGF and/or dexamethasone. Exclusion criteria: phakia, ocular hypertension, glaucoma, previous vitrectomy. Outcome measures included best-corrected visual acuity (BVCA), intraocular pressure (IOP), and central macular thickness (CMT), measured one, three (T3), six (T6), and twelve (T12) months post-injection. Data was compared with the Friedman test and significance was set at p < 0.05. Results : 18 eyes with a median duration of cDME of 45 months [25 - 118 months]. 77% of subjects either maintained or improved their BVCA (Fig. 1 and 2). 17% and 33% of subjects showed an improvement of 15 ETDRS letters or more at 3 and 12 months respectively (Fig. 3). 17% and 28% of subjects showed a CMT <250 microns at 3 and 12 months respectively (Fig. 4). The median change in CMT thickness was of -370 and -373.5 microns at 3- and 12-months post-injection respectively (p-value is .025). Changes in median IOP at 3- and 12- months post-injection were not statistically significant (p-value is .210). Ocular hypertension (OHT) was detected in 2 eyes (11%) one-week post-injection. Conclusions : 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 in pseudophakic patients but generally responds well to topical pressure-lowering medications.