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Ramin Khoramnia, Frank H J Koch, Usha Chakravarthy, Simon R Taylor, Joao Paulo Castro de Sousa, Clare Bailey; Real-life long-term outcomes for patients treated with the 0.19 mg fluocinolone acetonide (FAc; ILUVIEN) intravitreal implant for DME: Three-year follow-up from the RegIstry Safety Study (IRISS) .. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4862.
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Multicentre trials have demonstrated the safety and efficacy of the FAc implant in the management of DME over a 3 year period. There are few real-world studies with sufficiently large populations of patients with DME reporting 3 year outcomes. The current study reports the safety and effectiveness findings from the IRISS study.
IRISS (clinicaltrials.gov identifier NCT01998412) is a post-authorisation observational open label, registry safety study of the FAc implant in DME, conducted in the United Kingdom, Germany and Portugal. The study was designed to collect the data from 550 patients treated with the FAc implantation according to the European label with the first patient enrolled on 10 April 2014. Ethics committee approval was obtained in all countries prior to study inception. The current data extraction was completed in September 2019 and focuses on patients (n=295 patients / n=343 eyes) completing 3 years of monitoring post-treatment with the FAc implant. Safety was assessed in terms of the occurrence of intra-ocular pressure (IOP) events and their management. Effectiveness was determined from changes in best-recorded visual acuity (VA), particularly the percentage of eyes with ≥6/12 (20/40 or 70 ETDRS letters) vision.
At baseline, the mean age of patients was 66.3±10.8 (±SD) years, mean DME duration was 4.95 years and the majority of eyes were pseudophakic (85.7%). Mean IOP was 15.6±3.6 mmHg at baseline and remained below 21 mmHg for the 3 years of follow-up (+1.2mmHg between baseline and year 3; p=0.033). 39.9% of eyes required topical IOP-lowering drops and 3.2% (n=11/343) of eyes underwent IOP-lowering. During follow-up, VA remained stable / improved in 71% of eyes; ≥6/12 vision was achieved in 32% of eyes (vs. 18.6% at baseline; Figure); and, no significant changes were observed in eyes with a starting VA of ≥6/12.
These real-life outcomes confirm the long-term safety and effectiveness of the FAc implant in the treatment of DME after three years of treatment and in a cohort of patients larger than the EU registration trial population. The results from clinical practice show changes in IOP and visual acuity similar to those reported in the pivotal FAME trials and that in patients with good starting VA (≥70 letters) vision was stabilised for three years.
This is a 2020 ARVO Annual Meeting abstract.
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