First Author: W.Fusi-Rubiano UK
Co Author(s): C. Mukherjee R. Morjaria H. Palmer A. Manna
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Diabetic macula edema (DME) is the most common cause of blindness in patients with diabetes. Laser treatment and anti-vascular endothelial growth factor (VEGF) has been the mainstay treatment for DME. Despite this a high proportion remain unresponsive to these. Fluocinolone acetonide [FAc, Iluvien®] 0.19mg was approved by NICE in 2014 in pseudophakic patients unresponsive to conventional therapy. Fluocinolone acetonide in diabetic macular edema (FAME) studies showed clinical effectiveness for 36 months duration. This case series looks at clinical outcomes for pseudophakic patients treated with Iluvien®, insufficiently responsive to all other modes of therapy.
This is a single centre study investigating outcomes of pseudophakic patients treated with Iluvien® with DME unresponsive to conventional treatment. Patients were monitored and reviewed over a 3 year period.
Data was collected on all patients treated with Iluvien® following identification via an Iluvien® register during March 2017. Data on visual acuities (LogMAR), peak macula thickness and foveal thickness (micrometres), number clinically ‘dry’ at 3 years, need for top up treatments and duration until top up treatments (months) and complications was ascertained for all patients at 3 year time point from injection.
18 eyes were treated with Iluvien® in between January 2014 and December 2014. 3 year outcomes are available on 7 patients, 1 excluded as the indication for treatment was not DME. F:M 4: 2, Right eye: Left eye 4:2. Mean age was 69. Baseline stats: Mean VA: 0.68. Mean macula peak thickness: 474μm. Mean foveal thickness: 413μm. At 1 year: Mean change in VA: -0.12. >15 letter improvement in 16.6% (n=1). Mean reduction in macula peak thickness: 112μm. Mean reduction in central thickness: 102μm. At 2 years: Mean change in VA: -0.13. >15 letter improvement in 0%. Mean reduction in macula peak thickness: 80μm. Mean reduction in central thickness: 65μm. At 3 years: Mean change in VA: -0.17. >15 letter improvement in 50% patients (n=3). Mean reduction in macula peak thickness: 99μm. Mean reduction in central thickness: 64.5μm. 50% (n=3) were clinically ‘dry’ at 3 years. 83% (n=5) required top up treatment for recurrence with either laser or anti-VEGF. Mean duration until top up treatment needed: 13.5 months (range: 10-16 months). No patients had complications. None had further Iluvien® injections.
Real world outcomes of patients treated with Iluvien® showed an mean improvement in vision of 8.5 letters at 3 years and 50% getting >15 letter improvement from baseline. However, 5 eyes needed additional topup treatment with anti-VEGF or laser with mean time until top up just over 1 year. Sustained-release FAc 0.19mg implant appears to provide clinical benefit in patients with chronic DME unresponsive to other treatments and no adverse events were recorded in all 18 eyes.