First Author: T.Duncker GERMANY
Co Author(s): G. Duncker A. Rautenberg
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Iluvien® (fluocinolone acetonide; FAc) is indicated for use in patients with chronic diabetic macular edema (DME) that do not respond optimally to prior therapies. The implant contains the corticosteroid, FAc, which is continuously released at low levels in the eye, resulting in consistent control of inflammation and edema lasting for up to 36 months. In real-world practice patients will have received varying numbers and frequencies of prior treatments. Treatment with Iluvien® may be beneficial in reducing the overall treatment burden in DME.
A retrospective analysis of data collected at the Institut für Augenheilkunde Halle.
Data was collected as part of the prospective IDEAL study (registration number NIS 6752) which is currently ongoing in Germany. Records were reviewed and ten patients were identified that had been treated with Iluvien® and had information on the type and frequency of DME treatment in the 12 months prior to Iluvien®. Inspection of patient records revealed 3 patients that had received a dexamethasone implant within the 6 months prior to Iluvien® and this data was excluded from the analysis of prior therapies and effectiveness to avoid any concurrent effects. Following Iluvien® injection, all patients were monitored at baseline and 3 months (range, 84 to 98 days) after Iluvien® treatment was initiated. The effectiveness of Iluvien® was assessed in terms of changes in visual acuity (VA) and changes in central macular thickness (CMT). Safety outcomes were also assessed.
Patients (n=10) had a mean age of 66.5±9.7 (mean±SD) years, all had type 2 diabetes and 6 had a pseudophakic lens. The mean duration of DME was 47.3±24.0 months and all had been treated with laser photocoagulation and intravitreal injections since DME diagnosis. In the 12 months prior to Iluvien® (n=7), a total of 37 intravitreal injections were administered with a mean of 5.2 ranibizumab injections (range, 3 to 7; n=5) or 5.5 aflibercept injections (range, 4 to 7; n=2). Over the period of DME diagnosis there were a total of 114 intravitreal injections. Three months after the injection of Iluvien® there was an improvement in CMT from 356 µm to 308 µm (n=4) and stabilisation of VA which was 57 and 56 ETDRS letters at baseline and the last observation. In all patients (n=10), intra-ocular pressure (IOP) remained below 21 mmHg and one patient required dorzolamide IOP-lowering drops (this was one of the patients that had received prior dexamethasone and was does not form part of the prior therapies, VA and CMT results above). One patient required additional therapy during this timeframe and intravitreal aflibercept was combined with Iluvien®.
In the 12 months prior to Iluvien® patients received an average of 5.3 intravitreal injections (a total 37 injections in 7 patients) and after an insufficient response was confirmed, patients were switched to a single injection of Iluvien®. Patients demonstrated improved management of macular oedema and stable visual acuity. Iluvien® offers the potential to provide similar outcomes to those achieved with a first-line therapy but with fewer injections and sustained effects explained by the slow and low level of FAc released into the eye.