Latest data from an ongoing audit of real-life UK clinical practice published online in the journal Eye show the number of chronic diabetic macular edema (DME) patients with 6/12 vision, DVLA’s minimum requirement to drive in the UK, increased from a baseline of 18.1% to 39.6% 24 months after receiving a single Iluvien (190µg fluocinolone acetonide (FAc) intravitreal implant in applicator) injection.
Data have been collected on 345 eyes (305 patients) from the Medisoft electronic medical record (EMR) data systems used in 14 UK centers. At the 24 month point, the data show 86.7% of patients maintained or gained vision after receiving Iluvien in routine clinical practice. The mean best-recorded visual acuity (BRVA) increased from 51.9 to 57.2 letters at 24 months, an average 5.3 letter gain. 15% of patients achieved a ≥15 letter improvement at 12 months, increasing to 20.8% at 24 months.
Results show a significant reduction in retinal thickness, where the mean central subfield foveal thickness reduced from 451.2µm to 355.5µm (P<0.001) at the last observation point.
Patient vision outcomes were comparable to the Iluvien phase 3 clinical trial (FAME) results at 2 years, despite patients from this audit having more prior intravitreal treatments and hence more chronic DME. In the FAME trials, all patients had received prior laser therapy but few had received anti-vascular endothelial growth factor (anti-VEGF) therapies. However, in the Medisoft audit 84.6% of treated eyes had received at least one prior intravitreal treatment with a mean of 7.36 prior intravitreal treatments administered. In clinical practice, Iluvien was initiated at the clinician’s discretion in eyes with visual acuity (VA) ranging from 5-85 letters, a broader range compared with the FAME trials where VA was 19-68 letters at treatment initiation.
Raised IOP-related emergent events (defined as use of IOP-lowering medication, a change in IOP ≥10 mmHg from baseline and a rise in IOP >30mmHg or IOP-lowering surgery) were consistent with those seen in FAME at a similar timepoint, and within the known safety profile for intravitreal corticosteroids. Prior to receiving the FAc implant, 14.2% of eyes had already received IOP-lowering medication and 0.3% of eyes had already required IOP-lowering surgery. However, 86.1% of patients in the Medisoft audit did not require IOP-lowering treatment after receiving Iluvien.
“Often real-world vision outcomes of clinical treatment with intravitreal anti-VEGF injections are lower than reported in clinical trials as fewer injections are often given in real world practice. Because one injection of Iluvien delivers a continuous microdose to the retina for up to 3 years, compliance and clinical capacity issues are reduced and we have found that routine clinical practice achieves similar outcomes to the phase 3 trials," Clare Bailey, Consultant Ophthalmologist from Bristol Eye Hospital, who is leading the Medisoft audit, said in a company news release. "Patients who are suitable for switching to Iluvien are therefore likely to have improved quality of life due to vision gain and decreased requirement for additional therapies or clinic appointments. The burden on the health service is also likely to reduce for these patients, freeing up clinic capacity for other ophthalmology patients.”
About the Medisoft audit
The ongoing audit collects real-world data on routine clinical treatment of chronic diabetic macular edema (DME) patients with 0.2µg / day dose of the corticosteroid fluocinolone acetonide (FAc). The data were collected at 14 UK clinical sites using the Medisoft electronic medical record data system, which is used by more than 80 NHS trusts. Retrospective safety data, best-recorded visual acuity and a limited amount of data from optical coherence tomography have been gathered on 345 eyes (305 DME patients).