A study testing whether the cholesterol-lowering medicine fenofibrate can slow down the progression of diabetic eye disease

Phase 1

• Conditions: Diabetic retinopathy and diabetic maculopathy; MedDRA version: 20.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: PTClassification code 10025425Term: MaculopathySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-002656-24-GB
• Lead Sponsor: niversity of Oxford (Clinical Trials and Research Governance))

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1060

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified