First Author: A.Barros PORTUGAL
Co Author(s): R. Soares A. Gomes da Rocha J. Chibante-Pedro
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DME is a common complication of diabetic retinopathy and the leading cause for visual impairment in the working age population. The multi-factorial nature of DME has recently been described and numerous inflammatory cytokines and vascular endothelial growth factor (VEGF)-independent pathways have been identified. Therefore, corticosteroids which have both anti-pearmeability and anti-inflammatory effects should be considered in chronic stages of DME, following insufficient response to anti-VEGF agents. The aim of this analysis is to analyse the effects of a sustained, controlled low dose – corticosteroid (0.2 µg/day fluocinolone acetonide [FAc]) administered in chronic DME patients with insufficient response to prior therapies.
Centro Hospitalar Entre Douro e Vouga, E.P.E. - Santa Maria da Feira, Portugal
Data has been collected from 6 patients (7 eyes) with chronic DME who had undergone FAc single implant insertion after insufficient response to other treatment options. The maximum follow-up period extended up to 6 months. Functional response was assessed by from changes in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters and central foveal thickness (CFT) was confirmed by optical coherence tomography (OCT) examinations. Safety outcome measures included mean change in intraocular pressure (IOP). Data are presented as mean±standard deviation (SD).
The case series encompassed 6 patients (4 male and 2 female) and 7 eyes. The age of the patients was 68±7 years. Prior to Iluvien®, patient eyes had been treated with either ranibizumab (8±3.4 injections; n=7 eyes) and aflibercept (1.5±0.7 injections; n=2) and triamcinolone (1.9±0.7 injections; n=7) with no sustained or stable improvement in VA and/or CFT. At baseline, mean VA was 31.4±18.3 ETDRS letters and mean CFT was 492±226 µm. The last observation following Iluvien® administration, up to a maximum of 6 months, was used to account for varying durations of treatment. During this period, mean VA increased by +15.7±11.4 ETDRS letters at last observation. Mean CFT decreased by 113.7±144 µm. For all eyes, mean IOP remained below 21 mmHg, except for one who required IOP-lowering drops.
Our real-life clinical practice outcomes showed that a single 0.2µg/day FAc implant led to visual and the anatomical improvements, which were maintained during the follow-up period. Nevertheless, the long-acting action of 0.2µg/day FAc implant needs to be confirmed with longer follow-up. In our results, IOP elevation post-0.2µg/day FAc implant injection, was an expected side effect, manageable by IOP-lowering medication. Our preliminary results demonstrate that 0.2µg/day FAc implant is an effective long-term option in treating chronic DME.