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LENS: Lowering Events in Non-proliferative Retinopathy in Scotland

Sponsor
University of Oxford (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03439345
Collaborator
National Institute for Health Research, United Kingdom (Other), University of Glasgow (Other), University of Aberdeen (Other), University of Dundee (Other), University of Edinburgh (Other), NHS Scotland Diabetic Retinopathy Screening Collaborative (Other)
1,151
Enrollment
16
Locations
2
Arms
67.3
Anticipated Duration (Months)
71.9
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Fenofibrate 145 mg
  • Drug: Placebo Oral Tablet
 Phase 4

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 clinically significant 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 randomization, eligible participants will enter an active run-in phase of 6 to 10 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
1151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised Placebo-controlled Trial of Fenofibrate to Prevent Progression of Non-proliferative Retinopathy in Diabetes
Actual Study Start Date :
Jul 23, 2018
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fenofibrate 145 mg

Name: fenofibrate; Form: tablet; Dosage: 145 mg; Frequency: one tablet daily with normal renal function, one tablet every 2nd day with chronic kidney disease

Drug: Fenofibrate 145 mg
One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
Placebo Comparator: Placebo Oral Tablet

Name: placebo; Form: tablet; Dosage: not applicable; Frequency: one tablet daily with normal renal function, one tablet every 2nd 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)

Outcome Measures

Primary Outcome Measures

  1. Progression to clinically significant diabetic retinopathy/maculopathy [Approximately 4 years]

    The composite of progression to clinically significant diabetic retinopathy/maculopathy or any of retinal laser therapy, vitrectomy or intra-vitreal injection of medication for the treatment of diabetic retinopathy/maculopathy Clinically significant diabetic retinopathy is defined according to NHS Scotland's grading criteria.

Secondary Outcome Measures

  1. Components of the primary outcome (progression to clinically significant diabetic retinopathy/maculopathy; retinal laser therapy; vitrectomy; intra-vitreal injection of medication for treatment of diabetic retinopathy/maculopathy) reported separately [Approximately 4 years]

    Number of participants, respectively, in whom the following outcomes occur, reported separately: Number of participants with progression of diabetic retinopathy/maculopathy to clinically significant diabetic retinopathy/maculopathy (based on the NHS Scotland grading scheme) Number of participants requiring retinal laser therapy for diabetic retinopathy/maculopathy (based on patient report and health records) Number of participants requiring vitrectomy for diabetic retinopathy/maculopathy (based on the NHS patient report and health records) Number of participants requiring intra-vitreal injection for diabetic retinopathy/maculopathy (based on the NHS patient report and health records)

  2. Any progression of diabetic retinopathy/maculopathy [Approximately 4 years]

    Based on the NHS Scotland grading scheme

  3. Visual acuity [Approximately 4 years]

    Based on measurement of visual acuity at retinal screening visits

  4. The development of hard exudates within 1 disc diameter of the macula [Approximately 4 years]

    Based on the NHS Scotland grading scheme

  5. The development of macular oedema [Approximately 4 years]

    The accumulation of macular fluid as determined by optical coherence tomography (OCT) imaging

  6. Visual function (according to the VFQ-25 questionnaire) [Approximately 4 years]

    According to the VFQ-25 questionnaire

  7. Quality of life (according to the EQ-5D questionnaire) [Approximately 4 years]

    According to the EQ-5D questionnaire

  8. Total cost to the health service [Approximately 4 years]

    Health economic analysis

  9. Cost-effectiveness (incremental cost per QALY gained) [Approximately 4 years]

    Health economic analysis

Other Outcome Measures

  1. Change in urine albumin:creatinine ratio [Approximately 4 years]

    Based on collection of biochemical data

  2. The occurrence of major cardiovascular events (myocardial infarction, stroke, coronary and peripheral revascularisation) [Approximately 4 years]

    Based on patient history and medical records

  3. Minor and major non-traumatic lower limb amputation (minor [defined as distal to the ankle] or major [defined as through or proximal to the ankle]) [Approximately 4 years]

    Based on patient history and medical records

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Capable of giving informed consent

  2. Diabetes Mellitus (any type except gestational diabetes)

  3. 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)

  4. Willing to either complete electronic questionnaires or conduct telephone interviews for collection of data once every 6 months

Exclusion Criteria:

  1. Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)

  2. History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)

  3. History of acute or chronic pancreatitis

  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2X the upper limit of normal (ULN) according to local NHS laboratory reference range at screening visit

  5. ALT or AST >2.5X ULN according to local NHS laboratory reference range at randomisation visit

  6. Creatine kinase (CK) >3X ULN according to local NHS laboratory reference range at screening visit

  7. CK >3X ULN according to local NHS laboratory reference range at randomisation visit

  8. Estimated glomerular filtration rate (eGFR) <40mL/min/1.73m2 at screening visit

  9. eGFR <30mL/min/1.73m2 at randomisation visit

  10. Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)

  11. Female who is pregnant, breastfeeding, currently trying to become pregnant, or of child-bearing potential and not practising birth control

  12. Ongoing vitamin K antagonist (warfarin, phenindione, acenocoumarol), cyclosporine, colchicine, ketoprofen, daptomycin, fibrate therapy, or treatment with rosuvastatin 40mg daily

  13. Previous myositis, myopathy or rhabdomyolysis of any cause, or diagnosed hereditary muscle disorder

  14. Ongoing renal replacement therapy

  15. Any previous organ transplant

  16. Previous reported intolerance to any fibrate

  17. 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)

  18. 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

  19. 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.

  20. Not adherent to active run-in treatment

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 NHS Tayside Dundee United Kingdom
6 NHS Fife Dunfermline United Kingdom
7 NHS Lanarkshire East Kilbride United Kingdom
8 NHS Lothian Edinburgh United Kingdom
9 NHS Greater Glasgow and Clyde Glasgow United Kingdom
10 NHS Highland Inverness United Kingdom
11 NHS Ayrshire and Arran Kilmarnock United Kingdom
12 NHS Fife Kirkcaldy United Kingdom
13 NHS Forth Valley Larbert United Kingdom
14 NHS Borders Melrose United Kingdom
15 NHS Tayside Perth United Kingdom
16 NHS Lanarkshire Wishaw United Kingdom

Sponsors and Collaborators

  • University of Oxford
  • National Institute for Health Research, United Kingdom
  • University of Glasgow
  • University of Aberdeen
  • University of Dundee
  • University of Edinburgh
  • NHS Scotland Diabetic Retinopathy Screening Collaborative

Investigators

  • Principal Investigator: David Preiss, PhD FRCPath, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT03439345
Other Study ID Numbers:
  • CTSULENS1
First Posted:
Feb 20, 2018
Last Update Posted:
Jun 9, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Fenofibrate

Study Results

No Results Posted as of Jun 9, 2022