Real-life study assessing the effectiveness of intravitreal aflibercept injection (IAI) treatment of diabetic macular edema (DME) in UK routine clinical practice (DRAKO): Baseline Characteristics.

Abstract

Purpose : DRAKO is an ongoing prospective, observational study aiming to evaluate the effectiveness of IAI in DME with 2 year follow-up and describe routine clinical practice. The objective of this analysis is to describe baseline demographic and ocular characteristics of patients enrolled in the study.

Methods : DRAKO enrolled adult patients into two groups, cohort 1: anti-VEGF treatment naïve and cohort 2: prior anti-VEGF treatment other than IAI (with a minimal 28 day anti-VEGF treatment free interval). Patients were enrolled from 35 NHS centres in the UK from July 2016 to April 2018. The eye with worse visual acuity was defined as the study eye. Outcomes include refracted best corrected visual acuity (BCVA) and central subfield thickness (CST) utilising spectral domain optical coherence tomography. Descriptive statistics were used to analyse the demographic (age, gender, ethnicity, disease occurrence in fellow eye) and ocular data collected following enrolment.

Results : 750 patients were enrolled, 61.5% of patients being male, and with ages that ranged from 22 through 93. The largest ethnicity represented was Caucasian/ White (72.8%), with the major variation between cohorts observed in the Asian population (10.3% versus 19.8% of patients in cohort 1 and 2 respectively). Two-thirds of the population of patients were treatment-naive (cohort 1 (503)). The median ages [25^th, 75^th] for cohort 1 and cohort 2 were 63 [55,70] and 66 [57.5,73] respectively. DME was present in both eyes for almost half of patients assessed, 237 (47.1%) cohort 1 and 135 (54.7%) cohort 2. Baseline refracted BCVA and OCT were available for 95.7% and 99.1% of patients respectively. Lower median BCVA score and CST was observed in cohort 2 (median [25^th, 75^th]: BCVA score 73 [64,79] and 70 [61,77]; CST 436µm [407,486] and 412.5 µm [349.3,472] cohort 1 vs 2 respectively).

Conclusions : This is the first study within the UK to investigate IAI for DME in real-life post EU approval and NICE recommendations. The number of patients and sites included in the evaluation, and the high percentage of data available for baseline analysis are the strengths of the study and infer the benefit the study results may have on the future care of DME patients.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.