Assessing the effectiveness of intravitreal aflibercept in UK routine clinical practice for treatment-naïve patients with diabetic macular edema: DRAKO 2-year results

Abstract

Purpose : DRAKO (NCT02850263) is an observational, multicenter study, and is the first study to prospectively evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) for the treatment of patients with diabetic macular edema (DME) within routine clinical practice in the UK. Results are reported for the anti-vascular endothelial growth factor treatment-naïve cohort upon completion of the 2-year follow-up period.

Methods : Adult patients diagnosed with center-involving DME were enrolled and treated according to local practice. Primary endpoints were mean change from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 12 months (12M). Secondary endpoints included mean change from baseline in BCVA and CST at 24 months (24M), proportion of patients with ≥5, 10 or 15 letter gain or loss and the number of injections administered.

Results : At 12M (n=388), mean (SD) changes from baseline in BCVA of 2.5 (12.2) letters and CST of -119.1 (116.4) µm were reported. At 24M (n=326), mean (SD) BCVA remained above baseline (0.7 (12.7) letters) and CST was further reduced to -123.3 (104.3) µm from baseline. (24M Baseline; BCVA=71.5 letters; CST=447.6µm). At 24M, 38.0%, 16.6%, and 8.3% of patients gained ≥5, 10, and 15 letters, respectively; 26.1%, 15.3%, and 7.4% of patients lost ≥5, 10, and 15 letters, respectively. Patients received mean (SD) of 6.4 (2.0) injections in year 1 and 3.7 (2.3) injections in year 2. No correlation between the letter gain or loss and number of injections administered was observed. A total of 6.7% patients discontinued IVT-AFL treatment. In the safety population (n=507), 297 serious treatment emergent adverse events (TEAE) were reported, of which 22 were eye disorders. Serious TEAEs with a reasonable causal relationship with the injection procedure (n=4) or IVT-AFL treatment (n=4) were reported in 6 (1.2%) patients. Endophthalmitis was reported in 2 (0.4%) patients.

Conclusions : The DRAKO results indicate that IVT-AFL is an effective and well tolerated treatment for patients with DME in routine clinical practice, preserving or improving functional and anatomical outcomes over the 2-year treatment period. Functional outcomes were not correlated with number of injections administered. The safety profile of IVT-AFL was consistent with previous studies.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.