First Author: A.Brent UK
Co Author(s): S. Ch'ng T. Empeslidis V. Konidaris S. Banerjee
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In 2013 the National Institute for Health and Care excellence (NICE) in the UK approved Iluvien® as a treatment option for chronic DMO. NICE restricted its guidance to include only pseudophakic/aphakic patients where the oedema has been considered insufficiently responsive to current available therapies. At UHL we are offering Iluvien® treatment to this subset of refractory DMO patients. Our study demonstrates the real world data efficacy and safety outcomes of Iluvien® use. The authors compare the outcomes to current published real world and the FAME study results, as well as our own UHL outcomes prior to Iluvien® treatment.
Iluvien® has been available at UHL, a tertiary NHS hospital in the UK, since February 2014. All DMO patients at UHL who met the NICE criteria were offered treatment with Iluvien®.
All patients treated with Iluvien® at UHL have been incorporated into an on-going prospective audit of results. The primary outcome measure was that of subjective and objective visual changes over the 36 month treatment cycle. As a secondary outcome measure we have included an OCT analysis of central retinal thickness (CRT) and macular morphology changes. An adverse event analysis has been incorporated, with particular reference to intra-ocular pressure (IOP) changes and the subsequent need for glaucoma medications or invasive glaucoma surgery. Our study includes details of any rescue treatment offered to patients during their treatment with Iluvien® and analyses any subsequent impact this may have had on the results. The planned follow up regimen for patients was at week 1 post injection, then at months 1, 3, 6 and 12 during the first year, followed by 6 monthly intervals for a duration of 3 years. We have included data on any additional visits that were required either due to IOP treatment or due to an inadequate treatment response, necessitating the need for rescue treatment. This data has been compared to the visit frequency before Iluvien® treatment to determine if the workload burden has altered.
To date 24 eyes of 22 patients have been treated with Iluvien®. Subjectively 75% of patients have noticed visual improvement. Objective visual improvement has ranged from 0 to 1 Snellen lines. OCT analysis has shown a mean improvement in central retinal thickness of 89.8 microns. There was a reduction in CRT from the baseline in 75% of patients, no significant change in 8% and an increase in 17%. To date an IOP rise considered sufficient to warrant glaucoma medication has been detected in 29.2% (7) of eyes, which is slightly lower than the rate reported in the FAME study (37%). Two patients (8.3%) were not adequately controlled on medical treatment and required glaucoma surgery. This is higher than the reported FAME study rate of 4.8%. In both cases, after the surgeries, the IOP was adequately controlled without the need for long-term glaucoma medications. At UHL our use of rescue anti-VEGF therapy is similar to that of the FAME study, however we used significantly less rescue laser treatment. Even in the presence of rescue therapy and treatment for IOP rises, the number of hospital visits was significantly lower in patients treated with Iluvien® compared to the previous standard.
To date the majority of patients treated with Iluvien® at UHL have noticed a subjective visual improvement, although the objective VA improvement has been less marked than that demonstrated in the FAME study. This difference can likely be accounted for by the fact that in UHL we are using Iluvien® for chronic DMO patients who have already been shown to be refractory to standard treatment. Over three quarters of patients have demonstrated an OCT structural improvement of the macular, which predominantly plateaus at 3 months post injection. 29.2% have required glaucoma medications for IOP rises and 8.3% have required glaucoma surgery. Except for IOP changes there have been no other adverse operative or postoperative events. To date our data shows that compared to the current standard for refractory DMO treatment at UHL, Iluvien® is a safe and credible alternative. Iluvien® demonstrates potential to reduce the number of follow up hospital visits required and thus the workload burden on NHS units.