Use of flucinolone acetonide for patients with diabetic macular oedema: patient selection criteria and early outcomes in real world setting

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.

Clinical utility of intravitreal fluocinolone acetonide (Iluvien^®) implant in the management of patients with chronic diabetic macular edema: a review of the current literature

“…At 3 months after treatment with an FA implant, the mean reduction in CRT was 148 μm and the mean gain in visual gain was 6.4 letters. The majority (68.2%) of patients had improved CRT and improved vision at 3 months, but 4 out of the 22 eyes did not have any reduction in CRT at this time point 34. In another paper, Elaraoud et al also reported 6- and 12-month outcomes of a series of patients receiving bilateral FA implants for bilateral chronic DME.…”

“…The types of patients that clinicians are selecting for treatment with the FA implant in the real world can also be seen from the consecutive case series published by Elaraoud et al of 22 patients who received an FA implant over an 8-month period in three hospital sites 34. In this series, due to the restriction of its use in the UK to pseudophakic patients only, none of the treated eyes were phakic but all eyes had received prior intravitreal anti-VEGF therapies including six eyes with prior intravitreal triamcinolone.…”

Intravitreal Steroids in Diabetic Macular Edema

“…Real-life experience has demonstrated FA effectiveness and safety in the management of recalcitrant DME, in both unilateral and bilateral settings, also in vitrectomized eyes [39][40][41][42] .…”

Evaluation of the clinical effectiveness of fluocinolone acetonide 190 µg intravitreal implant in diabetic macular edema: a comparison between study and fellow eyes

“…In a retrospective study carried out by Elaraoud and colleagues, an improvement in visual acuity and CFT was observed in 15 out of 22 eyes treated with FAc intravitreal implant 25 . The subjects included were similar to those included in the ICE-UK study in that all included eyes had a pseudophakic lens and the majority had been previously treated with multiple anti-VEGF and laser therapies 25 . Unlike an RCT where people are randomized to FAc or sham injection, this study had a retrospective observational design whereby the untreated eye acted as a natural control that had been exposed to the same patient and disease factors.…”