LENS: Lowering Events in Non-proliferative retinopathy in Scotland
Diabetic retinopathy (DR) and diabetic maculopathy are common microvascular complications of diabetes mellitus. At an advanced (clinically significant) stage, these complications can lead to visual loss and blindness. While the risk of cardiovascular events in DM has been substantially reduced by various preventive strategies, there are few effective options to slow the progression of microvascular complications. However, sub-studies from two large cardiovascular trials have suggested that a drug called fenofibrate may be effective in slowing the progression of DR (measured as a composite tertiary outcome). Whilst suggestive of some benefit, these sub-studies do not provide definitive evidence. The LENS study aims to provide better evidence by randomising 1,060 individuals, at moderate to high risk of progressing to clinically significant DR, to either fenofibrate or placebo for at least a median of four years. Participants will be followed up for progression to clinically significant DR, retinal laser therapy, vitrectomy or intra-vitreal injection of medication owing to DR, health-related quality of life, and health service resource use. The economic evaluation will take the form of cost–utility analysis conducted alongside the trial, and modelling will be used to extrapolate longer-term cost-effectiveness if necessary.
More information on the trial is available at the NIHR project portfolio.
The trial is registered in the ISRCTN Registry: ISRCTN15073006
HERU researchers involved in this research project: Graham Scotland
External collaborators: D Preiss, J Armitage (University of Oxford); J Olsen (NHS Grampian), J Logue, N Sattar, H Murray (University of Glasgow), G Leese and H Colhoun (University of Dundee)