Lowering Events in Non-proliferative Retinopathy in Scotland
LENS
A Randomised Placebo-controlled Trial of Fenofibrate to Prevent Progression of Non-proliferative Retinopathy in Diabetes
2 other identifiers
interventional
1,151
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2018
Longer than P75 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedStudy Start
First participant enrolled
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2024
CompletedResults Posted
Study results publicly available
May 14, 2025
CompletedMay 14, 2025
January 1, 2025
5.3 years
February 5, 2018
November 11, 2024
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment
Primary outcome was a composite of the development of referable diabetic retinopathy or referable maculopathy, or treatment for diabetic retinopathy or maculopathy (including retinal laser therapy, vitrectomy or intravitreal injection of medication). Referable diabetic retinopathy was defined by the NHS Scotland's grading criteria as any development of R3, R4 or M2 disease. R3 (referable background diabetic retinopathy): any of four or more blot hemorrhages in both inferior and superior hemi-fields, or venous beading, or intraretinal microvascular abnormalities (IRMA); R4 (proliferative diabetic retinopathy): any active new vessels, or vitreous hemorrhage; M2 (referable maculopathy): any blot hemorrhages, or hard exudates within a radius of ≤1 optic disc diameter of the centre of the fovea. Adverse event reports of eye procedures, vitreous haemorrhages and macular oedema were adjudicated by experienced doctors at the Central Co-ordinating Office (CCO), masked to treatment allocation.
4.0 years (interquartile range, 3.6 to 4.3) years
Secondary Outcomes (24)
Number of Participants With the Individual Component of the Composite Primary Outcome: Development of Referable Diabetic Retinopathy or Maculopathy
4.0 years (interquartile range, 3.6 to 4.3) years
Number of Participants With the Individual Component of Composite Primary Outcome: Treatment for Diabetic Retinopathy or Maculopathy
4.0 years (interquartile range, 3.6 to 4.3) years
Number of Participants With Any Progression of Diabetic Retinopathy or Maculopathy Across the NHS Scotland Retinopathy Grading Scale
4.0 years (interquartile range, 3.6 to 4.3) years
Number of Participants With Referable Maculopathy (Exudates or Blot Haemorrhages Within One Disc Diameter of the Fovea)
4.0 years (interquartile range, 3.6 to 4.3) years
Number of Participants With The Development of Macular Oedema
4.0 years (interquartile range, 3.6 to 4.3) years
- +19 more secondary outcomes
Other Outcomes (3)
Percentage Change in Urine Albumin:Creatinine Ratio
4.0 years (interquartile range, 3.6 to 4.3) years
Number of Participants With Occurrence of Major Cardiovascular Events (Myocardial Infarction, Stroke, Coronary or Peripheral Revascularisation)
4.0 years (interquartile range, 3.6 to 4.3) years
Number of Participants With Occurrence of Non-traumatic Lower Limb Amputations
4.0 years (interquartile range, 3.6 to 4.3) years
Study Arms (2)
Fenofibrate 145 mg
EXPERIMENTALName: Fenofibrate; Form: tablet; Dosage: 145 mg; Frequency: One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
Placebo Oral Tablet
PLACEBO COMPARATORName: Placebo; Form: tablet; Dosage: not applicable; Frequency: One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
Interventions
One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- National Institute for Health Research, United Kingdomcollaborator
- University of Glasgowcollaborator
- University of Aberdeencollaborator
- University of Dundeecollaborator
- University of Edinburghcollaborator
- NHS Scotland Diabetic Retinopathy Screening Collaborativecollaborator
Study Sites (16)
NHS Grampian
Aberdeen, United Kingdom
NHS Lanarkshire
Airdrie, United Kingdom
NHS Ayrshire and Arran
Ayr, United Kingdom
NHS Dumfries and Galloway
Dumfries, United Kingdom
NHS Tayside
Dundee, United Kingdom
NHS Fife
Dunfermline, United Kingdom
NHS Lanarkshire
East Kilbride, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
NHS Highland
Inverness, United Kingdom
NHS Ayrshire and Arran
Kilmarnock, United Kingdom
NHS Fife
Kirkcaldy, United Kingdom
NHS Forth Valley
Larbert, United Kingdom
NHS Borders
Melrose, United Kingdom
NHS Tayside
Perth, United Kingdom
NHS Lanarkshire
Wishaw, United Kingdom
Related Publications (2)
LENS Collaborative Group. Design, recruitment and baseline characteristics of the LENS trial. Diabet Med. 2024 Sep;41(9):e15310. doi: 10.1111/dme.15310. Epub 2024 Feb 22.
PMID: 38385587BACKGROUNDPreiss D, Logue J, Sammons E, Zayed M, Emberson J, Wade R, Wallendszus K, Stevens W, Cretney R, Harding S, Leese G, Currie G, Armitage J. Effect of Fenofibrate on Progression of Diabetic Retinopathy. NEJM Evid. 2024 Aug;3(8):EVIDoa2400179. doi: 10.1056/EVIDoa2400179. Epub 2024 Jun 21.
PMID: 38905569RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Professor David Preiss
- Organization
- Nuffield Department of Population Health, University of Oxford
Study Officials
- PRINCIPAL INVESTIGATOR
David Preiss, PhD FRCPath
University of Oxford
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 20, 2018
Study Start
July 23, 2018
Primary Completion
November 17, 2023
Study Completion
February 16, 2024
Last Updated
May 14, 2025
Results First Posted
May 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Access Criteria
- Applications will be considered in accordance with Data Access Policy for the Nuffield Department of Population Health, University of Oxford.
Data generated by LENS will be available on application to bona fide academic researchers in accordance with the Data Access Policy for the Nuffield Department of Population Health, University of Oxford. Such approvals will also need to be consistent with the informed consent provided by participants. Any sharing of data derived from NHS Scotland data will need to comply with the approvals of the trial.