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.

Predictive factors for treatment outcomes with intravitreal anti-vascular endothelial growth factor injections in diabetic macular edema in clinical practice

“…However, in our study, only half of the participants (51.61%) had a ≥ 5 ETDRS letters improvement, with ~ 20% of participants losing vision at final follow-up. Our findings are consistent with other real-world observational studies, showing that patients with DME have lower visual gains than in clinical trials [55][56][57]. Poor treatment outcome has been attributed to undertreatment in many real-world studies [47,49].…”

Evaluation of standard-of-care intravitreal aflibercept treatment practices in patients with diabetic macular oedema in the UK: DRAKO study outcomes

“…The improved BCVA outcomes at M12 for treatment-naïve patients receiving five initial monthly injections (full loading dose) within window, in comparison to patients who did not receive these, was reported previously [17]. Further analysis for this cohort demonstrated that BCVA outcomes at the end of the follow-up period were marginally better in patients receiving the full loading dose compared to other patients (mean change from baseline of 1.4 letters compared to 0.4 letters, respectively); however, only one-third of patients received five loading injections (Table 2).…”

Evaluation of care with intravitreal aflibercept treatment for UK patients with diabetic macular oedema: DRAKO study 24-month real-world outcomes

“…It was previously reported that DRAKO patients in the anti-VEGF treatment-naive cohort demonstrated poor baseline glycaemic control, with a mean (SD) HbA 1c of 66.1 (20.5) mmol/mol [10]. During the 2-year follow-up period, little change was observed in mean HbA 1c levels for either cohort, with minor fluctuations resulting in 24-month changes from a baseline of 0.4 and −0.7 mmol/mol for the treatment-naive cohort and nontreatment-naive cohort, respectively.…”

“…The Month 24 analysis was conducted as described previously for the treatment-naive cohort at Month 12 [10]. Quantitative variables were summarised by descriptive statistics, and categorical variables using frequency distributions and percentages.…”