6-year outcomes of the United Kingdom Medisoft® audit study following treatment with the ILUVIEN® (fluocinolone acetonide) implant in patients with diabetic macular edema.

Abstract

Purpose : The Medisoft study was designed as a retrospective audit of eyes treated with the fluocinolone acetonide (FAc) implant and aimed to assess the long-term effectiveness and safety of FAc implant in patients with diabetic macular edema (DME) that persists or recurs despite treatment. Outcomes from this study have previously been reported in patients monitored for ≥3 years. We now report outcomes obtained in the last 3-years since the initial outcomes were reported.

Methods : The Medisoft audit tool was used to extract pseudo-anonymised electronic medical records (EMR), identifying only patients with DME that had been treated with the FAc implant across 14 UK clinical sites between 2014 and 2022. Clinical effectiveness and safety were measured.

Results : Data were available from 302 eyes (256 patients) with ≥3 years of follow-up. The mean follow-up period was 64.2±18.4 months [mean±SD]). Best-recorded visual acuity (BRVA) was 56.8±15.6 letters, 59.2±17.1 letters and 60.54±15.6 letters at baseline, 3 and 6 years respectively. At years 3 and 6, stable/improved BRVA was observed in 75.6% and 74.6% respectively. The proportion of eyes with 6/12 (20/40) or better BRVA rose from 22.5% at baseline to 35.2% and 39.7%, respectively. In terms of safety, mean IOP was 16.3±4.1 mmHg at baseline and remained below a mean value of 21 mmHg at years 3 and 6. Around one third (36.1%) of eyes required topical IOP-lowering drops to control elevations in pressure (versus 21.5% of eyes pre-FAc implant) and IOP was >30 mmHg at a single time point post-FAc implant in 25.5% of eyes (versus 10.6 pre-FAc implant).

Conclusions : Over a 6-year follow-up period, UK EMR data obtained in real-world practice revealed that three-out-of-four patients with DME and treated with a FAc implant benefited from stable/improved BRVA and that one-in-three had visual acuity 6/12 or better. This data was obtained since the first eye was treated in the UK and is an ongoing study that will continue to monitor the outcomes and the management of DME patients in clinical practice.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.