LENS version 1.0
Research type
Research Study
Full title
A randomised placebo-controlled clinical trial of fenofibrate to prevent progression of non-proliferative retinopathy in diabetes
IRAS ID
209579
Contact name
David Preiss
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Eudract number
2016-002656-24
ISRCTN Number
15073006
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
14/49/84, NIHR
Duration of Study in the UK
5 years, 4 months, 31 days
Research summary
WHY: Each year, 5,500 patients living with diabetes in Scotland need to see an NHS eye specialist because of worsening diabetic retinopathy which is when diabetes affects the inner layer of the eye. Retinopathy leads to the certification of blindness in ~1,400 patients in the UK annually, making it one of the most important causes of blindness in adults.
WHAT: Fenofibrate is a commonly used cholesterol-lowering drug which can be safely taken with a statin. Two large fenofibrate studies, called FIELD and ACCORD-Lipid, suggested that fenofibrate may well slow down and in some cases stop the progression of retinopathy. However, fenofibrate is not currently used for this reason and there is a need for better information. LENS is designed to provide this information. During the trial, participants will take either fenofibrate or placebo (an identical dummy) tablet and will have an equal chance of being allocated either tablet. Neither participants nor anyone they may speak to during the trial will know which tablet they are taking (fenofibrate or placebo).
WHO: LENS will recruit just over 1,000 adults with diabetes and mild to moderate retinopathy in Scotland, using existing NHS-based retinal screening and also research registers.
WHERE: The trial will be conducted at NHS hospitals throughout all eleven mainland Scottish health boards.
HOW: LENS will last approximately six years. Participants are expected to be treated for at least three years and will only be required to attend two face-to-face clinic visits, after which all follow-up will be conducted using questionnaires by telephone or by computer. All study medicine will be sent to participants by registered post.
FUNDING: The LENS Trial is financed by a grant from the NIHR, CTSU (University of Oxford) is underwriting the cost of drug packaging, storage and shipment and Mylan (the manufacturer of fenofibrate) is providing fenofibrate and placebo tablets.
REC name
West of Scotland REC 1
REC reference
16/WS/0149
Date of REC Opinion
27 Sep 2016
REC opinion
Further Information Favourable Opinion