Trial design
The LENS trial was a randomised, double-masked, pragmatic trial of fenofibrate vs. placebo in participants with diabetes and observable retinopathy. The trial was a hybrid decentralised trial with only the initial screening and randomisation visits taking place face-to-face. Participants received a 10-week supply of open-label fenofibrate during an active run-in before being randomised to either fenofibrate or placebo.
The primary outcome of LENS was time to the first occurrence of the composite of developing referable diabetic retinopathy or maculopathy, or treatment for either condition in either eye.