1. Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes
- Author
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Moneeb Saddiq, Jackie Napier, Ajay Kotagiri, Hellen McGoey, Simon P Kelly, Andrew Nolan, James S Talks, Sobha Sivaprasad, Faruque Ghanchi, and Peter H Scanlon
- Subjects
medicine.medical_specialty ,Standard of care ,Visual acuity ,genetic structures ,business.industry ,RA645.D54 ,Therapy naive ,03 medical and health sciences ,Ophthalmology ,0302 clinical medicine ,Diabetic macular oedema ,Cohort ,030221 ophthalmology & optometry ,Medicine ,RE ,030212 general & internal medicine ,medicine.symptom ,business ,Adverse effect ,Cohort study ,Aflibercept ,medicine.drug - 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 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.
- Published
- 2021
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