Status:
COMPLETED
Lowering Events in Non-proliferative Retinopathy in Scotland
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
University of Glasgow
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 par...
Eligibility Criteria
Inclusion
- Capable of giving informed consent
- Diabetes Mellitus (any type except gestational diabetes)
- Observable diabetic retinopathy/maculopathy (defined based on NHS Scotland grading criteria as: R1 in both eyes or R2 in one/both eyes at the most recent retinal screening assessment; or M1 in one/both eyes at any retinal screening assessment in the 3 years)
- Willing to either complete electronic questionnaires or conduct telephone interviews for collection of data once every 6 months
Exclusion
- Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
- History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
- History of acute or chronic pancreatitis
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2X the upper limit of normal (ULN) according to local NHS laboratory reference range at screening visit
- ALT or AST \>2.5X ULN according to local NHS laboratory reference range at randomisation visit
- Creatine kinase (CK) \>3X ULN according to local NHS laboratory reference range at screening visit
- CK \>3X ULN according to local NHS laboratory reference range at randomisation visit
- Estimated glomerular filtration rate (eGFR) \<40mL/min/1.73m2 at screening visit
- eGFR \<30mL/min/1.73m2 at randomisation visit
- Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)
- Female who is pregnant, breastfeeding, currently trying to become pregnant, or of child-bearing potential and not practising birth control
- Ongoing vitamin K antagonist (warfarin, phenindione, acenocoumarol), cyclosporine, colchicine, ketoprofen, daptomycin, fibrate therapy, or treatment with rosuvastatin 40mg daily
- Previous myositis, myopathy or rhabdomyolysis of any cause, or diagnosed hereditary muscle disorder
- Ongoing renal replacement therapy
- Any previous organ transplant
- Previous reported intolerance to any fibrate
- Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer within last 5 years other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- LENS participants can participate in other research studies, including clinical trials. The only exclusions related to co-enrolment will be: if any other study or trial excludes co-enrolment or if the intervention being investigated in another trial has the potential to interact with fenofibrate therapy.
- Not adherent to active run-in treatment
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
1151 Patients enrolled
Trial Details
Trial ID
NCT03439345
Start Date
July 23 2018
End Date
February 16 2024
Last Update
May 14 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
NHS Grampian
Aberdeen, United Kingdom
2
NHS Lanarkshire
Airdrie, United Kingdom
3
NHS Ayrshire and Arran
Ayr, United Kingdom
4
NHS Dumfries and Galloway
Dumfries, United Kingdom