Abstract
Introduction:The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany.Methods:This study was conducted across 16 sites in Germany and involved 81 eyes (63 patients) with persistent or recurrent DME and a prior suboptimal response to a first-line intravitreal therapy (primarily anti-VEGF intravitreal therapies).Results:Patients were followed-up for 30.8 ± 11.3 months (mean ± standard deviation) and had a mean age of 68.0 ± 10.4 years. Best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9 (P ⩽ 0.005, n=56; from a baseline of 49 letters) and this was maintained through to month 30 (P ⩽ 0.05, n = 42). There was a concurrent improvement in central macular thickness with a reduction from 502 µm at baseline to 338 µm at year 1 (P ⩽ 0.0001, n = 43). This effect was sustained to year 3 (i.e. 318 µm; P ⩽ 0.0001, n = 29). Mean intraocular pressure (IOP) remained constant between baseline and year 3 with a peak change of 1.9 mm Hg occurring at year 1. Elevated IOP was observed in a similar percentage of patients prior to (22.2% of cases) and following (27.2%) treatment with the FAc implant. In the majority of cases, these elevations were managed effectively with IOP medications.Conclusions:Despite substantial amounts of prior intravitreal treatments – primarily with anti–vascular endothelial growth factor (VEGF) drugs – this real-world study showed that sustained structural and functional improvements can last for up to 3 years with a single FAc implant.
Highlights
The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany
This means that anti–vascular endothelial growth factor (VEGF) therapy can be highly effective in the early phase but, as DME progresses towards the later phase, anti-inflammatory agents such as corticosteroids become more effective and anti-VEGF therapy becomes less effective
The eyes had been diagnosed with DME for 3.8 ± 2.9 years and they had been heavily pre-treated in the 12 months preceding FAc implantation – 92.5% had received laser therapy, 97.5% had received intravitreal therapy (predominantly antiVEGF – ranibizumab (91.1%) and bevacizumab (44.3%) – or intravitreal triamcinolone acetonide (41.7%)) and 48% had undergone a vitrectomy (Table 1)
Summary
The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany. Diabetic retinopathy (DR) is an important microvascular complication and is the leading cause of blindness in the working-age population of developed countries.[1,2,3] The biochemical pathways underpinning the pathogenesis of DR lead to the breakdown of the blood retinal barrier and the development of diabetic macular edema (DME), which is largely driven by the consequential effects of increased oxidative stress, inflammation and vascular dysfunction, all of which have been described in human and animal models of DR.[4] In terms of functional effects, there is increasing evidence to suggest that neuronal changes[5] may explain, in part, the early defects observed in DR, which include loss of colour vision, loss of contrast sensitivity, abnormalities in the electroretinogram and visual field defects. Neuronal dysfunction in DR is probably due to many biochemical changes, including impaired glutamate metabolism, loss of synapses and dendrites and apoptosis of ganglion cells Another early event is increased retinal leukostasis, which is significantly increased in an animal model of DR,[6] and, instead of an acute vasculitis, inflammation in this case has been described as a sustained, chronic inflammation. Clinicians need to tailor treatment towards corticosteroid therapy once patients are not responding sufficiently to anti-VEGF therapy (~40% had
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