EUCTR2016-002656-24-GBActive, not recruitingPhase 1
A randomised placebo-controlled clinical trial of fenofibrate to prevent progression of non-proliferative retinopathy in diabetes - LENS version 1.0
niversity of Oxford (Clinical Trials and Research Governance))0 sites1,060 target enrollmentStarted: May 23, 2018Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,060
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •i) Subjects capable of giving informed consent
- •ii) Diabetes Mellitus (any type except gestational diabetes)
- •iii) Age 18 years or above
- •iv) Observable diabetic retinopathy (defined in the Scottish national retinopathy grading scheme as R2 and/or M1 in one/both eyes, or R1 in both eyes) at the patient's most recent retinal screening visit
- •v) Willing to either complete electronic questionnaires or conduct telephone interviews for collection of questionnaire data once every 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 460
Exclusion Criteria
- •i) Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
- •ii) History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
- •iii) History of acute or chronic pancreatitis
- •iv) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2X the upper limit of normal (ULN) according to local NHS laboratory reference range
- •v) Creatine kinase (CK) >3X ULN according to local NHS laboratory reference range
- •vi) Estimated glomerular filtration rate (eGFR) <40mL/min/m2 at screening
- •vii) Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)
- •viii) Female who is pregnant, breastfeeding, currently trying to become pregnant, or of child-bearing potential and not practicing birth control
- •ix) Ongoing warfarin, cyclosporine, vitamin K antagonist (warfarin, phenindione, acenocoumarol), colchicine, ketoprofen, daptomycin or fibrate therapy
- •x) Previous myositis or rhabdomyolysis of any cause, or diagnosed hereditary muscle disorder
- •xi) Ongoing renal replacement therapy
- •xii) Any previous organ transplant
- •xiii) Previous reported intolerance to any fibrate
- •xiv) 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)
- •xv) 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
Investigators
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