Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes

Abstract

Objectives: DRAKO (NCT02850263) is a 24-month, prospective, non-interventional, multi-centre cohort study which enroled patients diagnosed with centre-involving diabetic macular oedema (DMO). The study aims to evaluate standard of care with intravitreal aflibercept (IVT-AFL) treatment in the UK. This analysis describes the anti-vascular endothelial growth factor (anti-VEGF) treatment-naive patient cohort after 12-month follow-up.

Methods: Study eyes were treated with IVT-AFL as per local standard of care. The mean change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline at 12 months were measured and stratified by baseline factors. The number of injections and safety data were also evaluated.

Results: A total of 507 patients were enroled from 35 centres. Mean (SD) baseline BCVA was 71.4 (12.0) letters and CST was 448.7 (88.7) µm, with 63.1% of patients presenting with baseline BCVA ≥ 70 letters (mean 78.1). Mean (SD) change in BCVA of 2.5 (12.2) letters and CST of -119.1 (116.4) µm was observed at month 12. A 7.3 letter gain was observed in patients with baseline BCVA < 70 letters. Mean number (SD) of injections in year one was 6.4 (2.1). No significant adverse events were recorded.

Conclusion: Year one results indicated that IVT-AFL was an effective treatment for DMO in standard of care UK clinical practice, maintaining or improving visual acuity in treatment-naive patients with good baseline visual acuity, despite some patients being undertreated versus the summary of product characteristics. These results also demonstrated the clinical importance and meaningful impact of diabetic retinopathy screening in the UK.

Conflict of interest statement

SS received consultancy fees from Bayer, Allergan, Novartis Pharma AG, Roche, Boehringer Ingelheim, Optos, Apellis, Oxurion, Biogen, Oculis and Heidelberg Engineering. SS is Editor-in-Chief for the Journal Eye. Faruque Ghanchi has been a consultant and speaker for Novartis, Bayer, Allergan, Alimera and Roche; and has received travel grants from Bayer and Novartis. SPK received travel grants from Bayer, research support from Bayer and Novartis Pharma AG, and participated in advisory boards for Novartis Pharma AG and Polyphotopics. AK received travel support from Novartis, Bayer, and Allergan, and speaker fees from Allergan and Bayer. JT participated in advisory boards for Bayer and Novartis; received travel support from Bayer; and received research grants from Bayer, Novartis and Roche. PS attended advisory boards for Pfizer, Allergan, Boehringer, Roche and Bayer, and his department has received educational, research, and audit grants from Allergan, Boehringer Ingelheim, Novartis, and Bayer. HM is an employee of Bayer Plc. AN is an employee of Bayer Plc. MS is an employee of O4 Research. JN is an employee of Bayer Plc.

© 2021. The Author(s).

Figures

Fig. 1. Patient disposition during the study and analysis summary.

DMO diabetic macular oedema, anti-VEGF anti-vascular endothelial growth factor, IVT-AFL intravitreal aflibercept, PPW per protocol window population, FAS full analysis set, BCVA best-corrected visual acuity, CST central subfield thickness, n number of patients per group.

Fig. 2. Primary outcome results stratified by baseline measure and BCVA letter gain or loss proportion.

A BCVA stratification, B BCVA letter gain and loss proportion and C CST stratification, by sub-population. BCVA best-corrected visual acuity, CST central subfield thickness, PPW per protocol window population, FAS full analysis set.