TY  - JOUR
A1  - Augustin, Albert J.
A1  - Bopp, Silvia
A1  - Fechner, Martin
A1  - Holz, Frank
A1  - Sandner, Dirk
A1  - Winkgen, Andrea
A1  - Khoramnia, Ramin
A1  - Neuhann, Thomas
A1  - Warscher, Marcus
A1  - Spitzer, Martin
A1  - Sekundo, Walter
A1  - Seitz, Berthold
A1  - Duncker, Tobias
A1  - Ksinsik, Christian
A1  - Höh, Helmuth
A1  - Gentsch, Daniela
T1  - 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)
T2  - European journal of ophthalmology
N2  - 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.
KW  - Steroid
KW  - ILUVIEN
KW  - DME
KW  - microdosing
KW  - Retro-IDEAL
KW  - 3years
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/50031
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-500310
SN  - 1724-6016
SN  - 1120-6721
N1  - This article is distributed under the terms of the Creative Commons Attribution 4.0 License (http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
VL  - 29
SP  - 1
EP  - 10
PB  - Sage
CY  - Thousand Oaks, Calif.
ER  -