Evaluation of real-world early response of DMO to aflibercept therapy to inform future clinical trial design of novel investigational agents

• Published in: Scientific reports 2020-10, Vol.10 (1), p.16499, Article 16499
• Main Authors: Halim, Sandra, Gurudas, Sarega, Chandra, Shruti, Greenwood, John, Sivaprasad, Sobha
• Format: Article
• Language: English
• Subjects: 692/1807; 692/308; 692/499; 692/53; 692/698; 692/699; 692/700; Acuity; Clinical trials; Clinical Trials as Topic; Cysts; Diabetes; Diabetes mellitus; Diabetic retinopathy; Drug therapy; Edema; Female; Humanities and Social Sciences; Humans; Macular Edema - drug therapy; Male; Middle Aged; multidisciplinary; Patients; Receptors, Vascular Endothelial Growth Factor - therapeutic use; Recombinant Fusion Proteins - therapeutic use; Retrospective Studies; Science; Science (multidisciplinary); Tomography; Tomography, Optical Coherence - methods; Vascular endothelial growth factor; Visual Acuity - drug effects; Visual impairment
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-020-73571-6

New clinical trials for diabetic macular oedema (DMO) are being designed to prove superiority over aflibercept when this agent is already very effective in improving visual acuity (VA) and DMO. The aim of this study was to determine the optimal inclusion–exclusion criteria for trials to aim for superiority in visual outcomes with newer agents. As Phase 1 studies are short duration, we aimed to evaluate the early response of aflibercept in a real-world cohort initiated on monthly aflibercept for 3 consecutive injections and observed the effects at 4 months. The sub-optimal responders were pre-defined based on different cut-offs for VA and central sub-field thickness (CST). 200 patients with treatment naïve DMO treated with 3 loading doses of aflibercept were included in the study. We found that those presenting with baseline VA of 35–54 ETDRS letters (n = 43) had higher proportion of sub-optimal responders compared to other categories (p