Three-year results from the Retro-IDEAL study: Real-world data from diabetic macular edema (DME) patients treated with ILUVIEN® (0.19 mg fluocinolone acetonide implant).

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.

• Authors: Albert J Augustin, Silvia Bopp, Martin Fechner, Frank Holz, Dirk Sandner, Andrea-M Winkgen, Ramin Khoramnia, Thomas Neuhann, Marcus Warscher, Martin Spitzer, Walter Sekundo, Berthold Seitz, Tobias Duncker, Christian Ksinsik, Helmuth Höh, Daniela Gentsch
• Journal: European journal of ophthalmology (Eur J Ophthalmol) Vol. 30 Issue 2 Pg. 382-391 (Mar 2020) ISSN: 1724-6016 [Electronic] United States
• PMID: 30884972 (Publication Type: Journal Article)

Chemical References

• Drug Implants
• Glucocorticoids
• Fluocinolone Acetonide

Topics

• Aged
• Diabetic Retinopathy (drug therapy, physiopathology)
• Drug Implants (therapeutic use)
• Female
• Fluocinolone Acetonide (administration & dosage)
• Germany
• Glucocorticoids (administration & dosage)
• Humans
• Intraocular Pressure (physiology)
• Intravitreal Injections
• Macular Edema (drug therapy)
• Male
• Middle Aged
• Retrospective Studies
• Tonometry, Ocular
• Visual Acuity (physiology)