owering Events in Non-proliferative retinopathy in Scotland

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1151

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 retinal screening 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 last 3 years)
4. Willing to either complete electronic questionnaires or conduct telephone interviews for collection of data once every 6 months

Exclusion Criteria

Current exclusion criteria as of 16/03/2021:

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 childbearing 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

_____

Previous participant exclusion criteria as of 18/10/2019:

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 13/02/2023:<br>Number of participants in whom any of the following outcomes occur during the trial: progression from having observable diabetic retinopathy/maculopathy to referable diabetic retinopathy/maculopathy, or requiring any of retinal laser therapy, vitrectomy or intra-vitreal injection of medication due to diabetic retinopathy/maculopathy.<br><br>Previous primary outcome measure:<br>Number of participants in whom any of the following outcomes occur during the trial: progression from having observable diabetic retinopathy/maculopathy to clinically significant diabetic retinopathy/maculopathy, or requiring any of retinal laser therapy, vitrectomy or intra-vitreal injection of medication due to diabetic retinopathy/maculopathy.

Secondary Outcome Measures