First Author: C.Bailey UK
Co Author(s): U. Chakravarthy A. Lotery G. Menon J. Talks
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The goal in the treatment of diabetic macular edema (DME) is to preserve/improve vision by preventing/reducing macular swelling. Current first-line treatment mainly involves intravitreal injections of anti-VEGF. Around 40% of patients will fail to respond sufficiently to first-line therapies. This group of patients can be considered for Iluvien® therapy. The current study assessed the clinical outcomes following an audit of UK electronic medical records (EMR) to determine efficacy and safety outcomes in real-world practice.
The present EMR based study examined safety and efficacy outcomes following Iluvien® therapy using data acquired from 14 clinical sites in the UK using the Medisoft audit tool.
The Medisoft audit tool was used to identify patients with chronic DME across the 14 participating centres and who had received the 0.2 μg/day FAc implant for the treatment of chronic DME, the licenced indication for Iluvien®. Non-diabetic patients and diabetic patients with no DME diagnosis were excluded from the analysis. Iluvien® patient records (n=311 / 345 eyes) were captured over a 24 month period. Extracted data included baseline demographics and disease characteristics (e.g., prior treatment for DME); the incidence of IOP elevation and management; additional ocular treatments administered post-0.2 μg/day FAc implant; vision outcomes; and change in central subfield foveal thickness (CSFT).
345 DME eyes from 305 patients were identified with a mean follow-up period of 428 days (up to 919 days). 84.6% of treated eyes had received at least one prior intravitreal treatment, with a mean of 7.36 prior intravitreal treatments. 15.4% of patients experienced a change in IOP of ≥10 mmHg and 7.2% experienced a rise above 30 mmHg. 13.9% of eyes treatment-emergent IOP was managed with IOP-lowering drops. No eyes required trabeculoplasty and one eye required a trabeculectomy to manage elevated IOP. Over the same time frame there were improvements in CSFT (-95.7 microns from a baseline of 451.2 microns) and 86.7% of patients conserve/increase their visual acuity (VA) at 24 months. Prior steroid therapy showed that in patients previously treated with steroids, IOP-related events post-0.2 μg/day FAc implant were more frequently reported in cases with prior IOP events than no prior IOP events. Moreover, patients, with or without a prior steroid, revealed that a history of any prior IOP-related events before administration of the 0.2 μg/day FAc implant was associated with a higher prevalence of IOP elevation (to >30 mmHg) and an increase in the number of eyes requiring IOP-lowering medication after 0.2 μg/day FAc administration.
The current extraction of data is from a larger number of patients with a longer mean follow-up compared to previous extractions and shows mean improvements in VA and CSFT were sustained at the last observation point, which was 24 months for VA. The impact of prior steroid therapy on safety outcomes following treatment with Iluvien® reveals that the history and severity of IOP-related events prior to its administration may be an important clinical tool in predicting and mitigating the likelihood of any subsequent IOP-related events.