First Author: D.Gosling UK
Co Author(s): D. Gosling F. Quhill C. Brand
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In the UK National Health Service, guidelines by the National Institute for Health and Care Excellence positions fluocinolone acetonide intravitreal implant (Iluvien®, Alimera Sciences) as a second line agent for pseudophakic eyes with chronic diabetic macular oedema (DMO). The FAME trial demonstrated a role for fluocinolone implant as a treatment for refractory DMO, with effects through to 36 months. However, the day-to-day workload of retina specialists includes a greater heterogeneity of patients than is represented in control trials. We report our experience of safety and efficacy in our first cohort with 24 months follow up.
We report the ‘real-world’ performance of fluocinolone implant from our first cohort of treated patients in a large teaching hospital in Sheffield, UK.
A retrospective review of the electronic patient record (Medisoft) at a single UK ophthalmology department. Data from consecutive eyes with a 24 month clinic follow up were included.
Between March and September 2014, 18 patients (21 eyes) received fluocinolone implant. All were pseudophakic and had been unresponsive to previous treatment or did not meet criteria for such treatment on the NHS. 12 month improvements in both visual acuity and central macular thickness were maintained over 24 months. Mean gain of 14.9 letters at 12 months reducing to 11.5 letters gain (p=0.004) at 24 months. Mean reduction in central macular thickness by 215 microns at 12 months and 216 microns (p<0.001) at 24 months. 48% of eyes required no further laser or intravitreal treatment. There was a mean increase in the number of IOP drops used of 0.1 drops per eye (p=0.19). None required incisional glaucoma surgery.
The ‘real-world’ data reported here demonstrates greater acuity and anatomical gains than seen in the FAME study over a 24 month period along with excellent safety profile. Further follow up to include 36 month outcomes is needed to determine if complete FAME study gains can be translated to a real world scenario.