Results from the RETRO-IDEAL study assessing the real-world ILUVIEN (fluocinolone acetonide) outcomes in patients with chronic diabetic macular edema (DME) up to 3 years after therapy was initiated.

Session Details

Session Title: Free Paper Session 7: Vascular Diseases & Diabetic Retinopathy II

Session Date/Time: Thursday 07/09/2017 | 14:30-16:00

Paper Time: 14:30

Venue: Room 117

First Author: : A.Augustin GERMANY

Co Author(s): :                                 

Abstract Details

Purpose:

The FAME study was the pivotal trial supporting the registration of ILUVIEN (fluocinolone acetonide) in Europe (in 2013) and the USA (in 2014). After 3 years of therapy, patients suffering from chronic DME experienced an overall improvement in best-corrected visual acuity (BCVA) of +7.6 ETDRS letters and a reduction in central retinal thickness of 187 microns. The RETRO-IDEAL study is being conducted in Germany and is designed to assess ILUVIEN real-world outcomes at 3 years. The results from interim analyses are reported.

Setting:

RETRO-IDEAL is a retrospective analysis of ILUVIEN treated patients with the aim of collecting the results from 100 patients with 3 years follow-up. The current interim analysis, recorded up to the end of March 2017, reports the results from 16 eyes from 4 centres in Germany.

Methods:

Data were collected from diabetic patients that had been diagnosed with DME and treated with ILUVIEN due to suboptimal response to first-line intravitreal agents. 69% of treated eyes had undergone previous vitrectomy. After the injection of ILUVIEN, patients were monitored at baseline and at subsequent follow-up time points over a period of 36 months. Functional and structural responses were evaluated from changes in visual acuity (VA; measured using ETDRS letters) and central macular thickness (CMT), respectively. Safety outcomes were also assessed with a focus on elevated intraocular pressure (IOP). Values are reported as means ± standard deviation.

Results:

Patients’ mean age was 68.88±10.13 years, with duration of DME of 4.58±3.17 years. In the 12 months prior to ILUVIEN, the mean number of intravitreal injections (anti-VEGF and corticosteroid injections) was 5.25. At baseline 5 treated-eyes were phakic, with cataract removal performed in 3 patients between 8 and 531 days post-ILUVIEN. In the whole group the follow-up period was 974 days (range, 309 to 1117). Mean baseline VA was 47 letters (range, 20 to 70), increasing by 8 letters (-9 to +30). CMT decreased by 227 µm (-22 to -449) from a baseline value of 514 µm (365 to 694). Ten patients had > 1000 days follow-up (mean, 1077 days) and baseline and changes were similar (+9 letters and -248 µm). In eyes with recorded follow up, 60% had IOP ≤25 mmHg during the period of observation. 6/16 eyes (38%) required topical therapy due to IOP increase.

Conclusions:

In patients that have had suboptimal outcomes despite substantial amounts of prior treatments with anti-VEGF and other DME therapies, this interim analysis from real-world clinical practice shows sustained improvements lasting up to 36 months following treatment with a single ILUVIEN implant. This duration of action is in agreement with the results from the FAME studies. Additionally, the rate of emergent IOP was similar to that observed in the FAME study. In this small cohort, improvements in VA and CMT were numerically higher than reported in the FAME study. However, the inclusion of more patients is needed to confirm these findings.

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