Effectiveness of intravitreal aflibercept injections for anti-VEGF treatment-naïve patients with diabetic macular edema in UK routine clinical practice (DRAKO): 12-month results

Abstract

Purpose : DRAKO is an ongoing prospective, observational study evaluating the effectiveness of intravitreal aflibercept (IVT-AFL) injections for diabetic macular edema (DME) in UK routine clinical practice over a 2-year follow-up period. This analysis describes the change from baseline (BL) to Month 12 (m12) in best-corrected visual acuity (BCVA) and central subfield thickness (CST) in the anti-VEGF treatment-naïve patient cohort of the study.

Methods : Data were analyzed following an interim database lock at m12 for patients for whom BCVA or CST data were reported at BL and m12 within a +/− 1-month window (N=388). Summary statistics were used to describe the change from BL at m12 for BCVA and CST, and subsequently stratified by BL characteristics. The number of injections administered in the first year and the proportion of patients with 5, 10, and 15-letter gains or loss were calculated. Adverse events were listed using the MedDRA coding system and summarized by category. All analyses were conducted using SAS 9.4.

Results : Mean (standard deviation [SD]) BL BCVA was 71.4 (12.0) letters, with 65.3% of patients presenting with BL BCVA ≥70 letters (mean 78.1). Mean (SD) BL CST was 448.7 (88.7) µm. A mean (SD) change from BL in BCVA of 2.5 (12.2) letters and CST of −119.1 (116.4) µm was observed at m12. The mean increase in BCVA letters at m12 by BL subgroup (<35, 35–49, 50–69 and ≥70 letters) was 23.6, 14.4, 5.3 and 0.1 letters respectively. The mean decrease in CST at m12 by BL subgroup (<400 and ≥400 µm) was 42.5 and 134.3 µm, respectively. Overall, 40.2%, 20.1%, and 8.8% of patients gained 5, 10, and 15 letters, respectively; 16.5%, 9.8%, and 5.9% of patients lost 5, 10, and 15 letters, respectively. The mean number (range) of injections in year one was 6.4 (1–12). Overall, 7.6% (N=14) of serious adverse events were ocular related; vitreous and retinal hemorrhages and retinal tears were most commonly observed.

Conclusions : Interim results demonstrate the efficacy of diabetic retinopathy screening in the UK, with almost two-thirds of treatment naïve patients presenting with good BL vision. Year one results indicate that IVT-AFL is an effective treatment for DME in real-world UK clinical practice, maintaining or improving visual acuity in these patients despite some being undertreated versus label.

This is a 2020 ARVO Annual Meeting abstract.