First Author: R.Khoramnia GERMANY
Co Author(s): K. Ceglowska J. Wasiak I. Dacheva T. Tandogan F. Hengerer G. Auffarth
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Iluvien® (Fluocinolone Acetonide) is indicated for the treatment of chronic diabetic macular edema (DME) delivering a continuous, sustained microdose of the corticosteroid fluocinolone acetonide (FAc) for up to 3 years into the vitreous of the eye. The goal of this observational clinical study was to assess the efficacy and safety outcomes following the use of Iluvien®.
University Eye Clinic Heidelberg, Heidelberg, Germany
A prospective monocentric audit has been conducted so far in 14 eyes (10 patients) with DME that had been treated with a single Iluvien® implant between April 2014 and October 2015. Iluvien® was administered after a suboptimal response to a prior DME therapy. Efficacy (visual acuity [VA]) and safety parameters (intraocular pressure [IOP]) were assessed at baseline and after the single injection of Iluvien® (average follow-up was 288.1 days or 9.6 months). Values are reported as means throughout.
Mean age of patients was 69.4 years. 10 eyes were pseudophakic and 4 were phakic. Prior DME therapies included: bevacizumab (n=9), ranibizumab (n=8 eyes), dexamethasone implants (n=7), panretinal photocoagulation (n=9) and focal laser (n=5). Iluvien® therapy led to a mean gain in VA, from baseline, of +3.1 ETDRS letters. In patients previously treated with dexamethasone, the gain in VA from baseline was +6.7 letters. Overall VA increased or was maintained (≥0 letter gain) in 84.6 % of eyes. In 10 eyes anti-VEGF therapies were combined with Iluvien® to optimize retinal therapy. In a single eye, cataract extraction was performed concurrently with Iluvien® injection. In 1 eye, IOP increased to above 30 mm Hg and 3 eyes (21.4%) required IOP-lowering drops to effectively manage IOP, despite 5 eyes having been previously diagnosed with glaucoma.
Iluvien® had a good safety profile irrespective of existing glaucoma. Iluvien® brought a functional benefit for the majority of patients (84.6%) previously treated with DME therapies with a significant gain reported following prior injection of Ozurdex®. Anti-VEGF was combined with Iluvien® in the majority (n=10/14) of patients to optimize decreases in retinal edema.