NCT03439345

Lowering Events in Non-proliferative Retinopathy in Scotland

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,151 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 randomisation, eligible participants will enter an active run-in phase of 6 to 10 weeks.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Fenofibrate 145 mg	One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
DRUG	Placebo Oral Tablet	One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)

Timeline

• Start date: 2018-07-23
• Primary completion: 2023-11-17
• Completion: 2024-02-16
• First posted: 2018-02-20
• Last updated: 2025-05-14
• Results posted: 2025-05-14

Locations

16 sites across 1 country: United Kingdom