Abstract
Purpose :
To present an area-under-the-curve (AUC) analysis of the VA results of the Retro-IDEAL study.
Methods :
The Retro-IDEAL study is a retrospective study which was designed to assess real-world outcomes in patients suffering from diabetic macular edema (DME) who had been treated with the 0.19 mg fluocinolone acetonide (FAc; ILUVIEN®) implant in Germany. This study was conducted in accordance with the Declaration of Helsinki and Germany’s Data Protection Act (AMG §4, (23), Satz 3). The results of 94 eyes (81 patients with a mean age of 66.9±12.2 years) from 16 centers in Germany are presented. Visual acuity (VA) outcomes, converted from Snellen fraction to an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, were recorded. The trapezoidal rule was used to calculate AUC based on the VA letter scores. AUC was calculated from time zero (i.e. baseline) to year 3 and presented as mean VA change per day.
Results :
Baseline VA prior to injection of the FAc implant was 49.8±17.4 letters. During the 3 year follow-up VA increased by 4.6 letters at year 1. This increase was maintained at year 2 (4.8 letters) and year 2.5 (5.0 letters). Between 2.5 and 3 years VA started to decrease with a slight remaining improvement of 1.4 letters at year 3. The AUC analysis revealed an overall gain of 3.27 letters per day that was sustained throughout the 3-year treatment period with the FAc implant. Further analysis using the AUC approach revealed that 62.8% of patients had stable or improved VA (i.e. ≥0 letters per day for 3 years).
Conclusions :
The AUC method is particularly relevant for evaluating outcomes for sustained release implants, which provide continued drug-release over long-periods of time. The AUC approach provides a more holistic clinical approach as opposed to a single time point measurement. In this analysis of published data from the Retro-IDEAL study, the AUC method revealed VA gains that were evident for up to 3 years.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.