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Lowering Events in Non-proliferative Retinopathy in Scotland — LENS  

Diabetic Retinopathy Clinical Trial

Official title:
A Randomised Placebo-controlled Trial of Fenofibrate to Prevent Progression of Non-proliferative Retinopathy in Diabetes

Clinical Trial Summary

LENS is a streamlined multicentre randomized placebo-controlled parallel-group trial investigating the effect of fenofibrate treatment on the progression of diabetic retinopathy/maculopathy

Clinical Trial Description

LENS is a phase 4 randomised placebo-controlled clinical trial of fenofibrate in participants with diabetes and observable retinopathy or maculopathy. The trial aims to recruit approximately 1,060 participants and to treat them for a median duration of at least 4 years. The main aim of LENS is to investigate the effect of fenofibrate therapy on progression to referable diabetic retinopathy/maculopathy. The trial will be conducted using a pragmatic streamlined trial design with the only planned face-to-face visits being an initial screening visit, followed by a randomisation visit eight weeks later. Contact with participants thereafter will be by means of regular telephone or computer questionnaire, and outcome and safety data will also be sought by means of linkage to NHS Scotland registries. Prior to randomization, eligible participants will enter an active run-in phase of 6 to 10 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03439345
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase Phase 4
Start date July 23, 2018
Completion date February 16, 2024
View Details
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