Three year results from the Retro IDEAL study: Real world data from diabetic macular edema (DME) patients treated with ILUVIEN(r) (0.19 mg fluocinolone acetonide implant)
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(r) (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 um at baseline to 338 um at year 1 (P 0.0001, n 43) This effect was sustained to year 3 (i.e. 318 um; 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.
European journal of ophthalmology