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

Sobha Sivaprasad,Simon P Kelly,Hellen Mcgoey,Jackie Napier,Ajay Kotagiri,Faruque Ghanchi,James Talks,Andrew Nolan,Peter Scanlon,Moneeb Saddiq

doi:10.1038/s41433-021-01624-9

Abstract

ObjectivesDRAKO (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.MethodsStudy 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.ResultsA 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.ConclusionYear 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.

Highlights

Diabetes, including its associated complications, is an escalating healthcare problem, with treatment estimated to cost around 10% of the UK’s entire National Health Service (NHS) budget [1]
The mean baseline best-corrected visual acuity (BCVA) for DRAKO (71.4 letters) was substantially higher than measures reported in pivotal clinical trials (VIVIDDMO and VISTADMO aflibercept cohorts reported mean baseline BCVA of 59.8 letters and 59.1 letters, respectively) and in other prospective observational Diabetic macular oedema (DMO) studies (APOLLON and POLARIS) [10, 15, 16]
When comparing baseline visual acuity (VA) in these UK cohorts, a clinically relevant difference of 11 letters in baseline VA was observed between DRAKO and POLARIS

Summary

Introduction

Diabetes, including its associated complications, is an escalating healthcare problem, with treatment estimated to cost around 10% of the UK’s entire National Health Service (NHS) budget [1]. The global prevalence of diabetes is projected to increase from the current 9.3% to 10.2% in 2030, affecting 578.4 million adults between the ages of 20–79 years, further increasing the burden on health systems [2]. Diabetic macular oedema (DMO), a microvascular complication of diabetes that can occur at any stage of retinopathy, is the most common cause of visual acuity (VA) loss in patients with diabetes and the most frequent cause of blindness in young and mid-aged adults in the developed world. The use of anti-vascular endothelial growth factor (anti-VEGF) treatments for DMO has seen outcomes for many patients improve.

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