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

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.

“Intravitreal fluocinolone acetonide implant: a prospective, pilot study on patients with chronic diabetic macular edema”

“…Moreover, other real-life studies provided lower visual outcomes, with BCVA gains ranging from + 3.8 to 5.0 letters after 12 months (25). In our study, the long-standing course of the chronic DME in association with the multiple injections before FAc implant may have led to a higher percentage of disorganization of the inner retinal layer (DRIL) in comparison with previous studies, in which an early-switch to Fac has been performed (15). In this regard, it is known that the presence of DRIL is predictive for visual function recovery (26).…”

“…FAc implant has the clinical indication for the management of visual loss due to chronic/relapsing DME, which is insu ciently responsive to other rst-line available therapies (11). After the pivotal FAME trial, other real-life studies provided promising results about FAc clinical e cacy and safety pro le (12)(13)(14)(15)(16)(17)(18); however, despite the encouraging results documented, there is still need of further real-life evidence of Fac clinical outcomes.…”

Two-Week Central Macular Thickness Reduction Rate >37% Predicts the Long-Term Efficacy of Anti-vascular Endothelial Growth Factor Treatment for Macular Edema Secondary to Retinal Vein Occlusion

“…The anti-VEGF drugs have been widely used in ocular diseases such as exudative age-related macular degeneration, diabetic macular edema, choroidal neovascularization, and RVO-ME, and have shown good safety and efficacy. Previous retrospective and prospective studies have shown that the anti-VEGF treatment for RVO-ME in real-word has achieved significant retinal structure improvement and visual function recovery ( 5 , 17 , 29 , 33 , 37 , 38 ). The patients included in this study are divided into the mAb group (ranibizumab injection) and the Fc group (injection of conbercept or aflibercept) according to their mechanism of action.…”

“…has achieved significant retinal structure improvement and visual function recovery (5,17,29,33,37,38). The patients included in this study are divided into the mAb group (ranibizumab injection) and the Fc group (injection of conbercept or aflibercept) according to their mechanism of action.…”

“…This blockage is often associated with the hardening of arteries (such as atherosclerosis) and the formation of a blood clot ( 2 ). Risk factors for RVO include older age, active smoking, hypertension, diabetes mellitus type II, hyperhomocysteinemia, dyslipidemia, carotid artery disease, glaucoma, and obstructive sleep apnea syndrome ( 3 – 5 ). The two most common types of RVO are central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) according to where the occlusion is located.…”