Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (CLARITY): A Multicentre Phase IIb Randomised Active-Controlled Clinical trial
Dr. Sobha Sivaprasad, NIHR Moorfields Biomedical Research Centre
The CLARITY trial is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of proliferative diabetic retinopathy. The aim of this randomised controlled trial is to determine the efficacy, safety, and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and Placental Growth factor (PLGF), in proliferative diabetic retinopathy, and to investigate the impact on local oxygenation. 220 subjects with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or panretinal photocoagulation for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness.