Abstract
IntroductionFluocinolone acetonide slow release implant (Iluvien®) was approved in December 2013 in UK for treatment of eyes which are pseudophakic with DMO that is unresponsive to other available therapies. This approval was based on evidence from FAME trials which were conducted at a time when ranibizumab was not available. There is a paucity of data on implementation of guidance on selecting patients for this treatment modality and also on the real world outcome of fluocinolone therapy especially in those patients that have been unresponsive to ranibizumab therapy.MethodRetrospective study of consecutive patients treated with fluocinolone between January and August 2014 at three sites were included to evaluate selection criteria used, baseline characteristics and clinical outcomes at 3-month time point.ResultsTwenty two pseudophakic eyes of 22 consecutive patients were included. Majority of patients had prior therapy with multiple intravitreal anti-VEGF injections. Four eyes had controlled glaucoma. At baseline mean VA and CRT were 50.7 letters and 631 μm respectively. After 3 months, 18 patients had improved CRT of which 15 of them also had improved VA. No adverse effects were noted. One additional patient required IOP lowering medication. Despite being unresponsive to multiple prior therapies including laser and anti-VEGF injections, switching to fluocinolone achieved treatment benefit.ConclusionThe patient level selection criteria proposed by NICE guidance on fluocinolone appeared to be implemented. This data from this study provides new evidence on early outcomes following fluocinolone therapy in eyes with DMO which had not responded to laser and other intravitreal agents.
Highlights
Fluocinolone acetonide slow release implant (Iluvien®) was approved in December 2013 in UK for treatment of eyes which are pseudophakic with Diabetic Macular Oedema (DMO) that is unresponsive to other available therapies
The patient level selection criteria proposed by National Institute for Care and Health Excellence (NICE) guidance on fluocinolone appeared to be implemented
This data from this study provides new evidence on early outcomes following fluocinolone therapy in eyes with DMO which had not responded to laser and other intravitreal agents
Summary
Fluocinolone acetonide slow release implant (Iluvien®) was approved in December 2013 in UK for treatment of eyes which are pseudophakic with DMO that is unresponsive to other available therapies. The United Kingdom was one of the first countries to approve the use fluocinolone implant for treatment of DMO but current National Institute for Care and Health Excellence (NICE) guidance recommends its use only in pseudophakic eyes with DMO that has been unresponsive to other available therapy [10] Due to this unique selection criteria and early exposure to this technology, the setting in our National Health Service in the United Kingdom is ideal for reporting the implementation of this guidance, in particular, the early experiences in patient selection behaviour by clinicians and early clinical outcomes in the real world. This retrospective study reports the initial real world experience of implementation of TA301 in the clinical setting, in particular, the patient level criteria used for selection of patients for intravitreal fluocinolone implant, the initial treatment response and the short term safety profile
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