ActivePhase 3ACTRN12611000249954

The Fenofibrate And Microvascular Events in Type 1 diabetes Eye: A randomised trial to evaluate the efficacy on retinopathy and safety of fenofibrate in adults with type 1 diabete. A multicentre double-blind placebo-controlled study in Australia and internationally

Sponsor

NHMRC Clinical Trials Centre, University of Sydney

Enrollment

450 participants

Start Date

Nov 3, 2016

Study Type

Interventional

Conditions

Eye disease (retinopathy) in type 1 diabetes mellitus Diabetic nephropathy in type 1 diabetes mellitus

Summary

Diabetes is the commonest cause of adult onset blindness. Vision loss, which is irreversible, is a most feared complication of diabetes. A blood fat lowering drug called fenofibrate, available in Australia, has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of fenofibrate in 450 adults with Type 1 diabetes who are at high risk of eye damage.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether fenofibrate (a cholesterol-lowering medication) can slow or prevent eye damage (retinopathy) in adults with type 1 diabetes. Participants must be 18 or older, have type 1 diabetes with early-stage retinopathy in at least one eye, and have adequate kidney function. The study is double-blind and placebo-controlled, meaning neither participants nor doctors know who receives the real drug.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All eligible participants will complete a 6 week run-in phase comprising either a once daily tablet of 145 mg fenofibrate or matching (inert lactose) placebo. After completion of the run-in period participants will be immediately randomised to either a once daily tablet of 145 mg fenofibrate or placebo, taken for 36 months. Participants ineligible for the run-in phase will be followed up by an annual phone call and a clinic visit at the end of the follow up period for blood and urine sampling. Concurrent to the main study a small number of age and gender matched nondiabetic reference group participants will provide blood and urine samples for comparison research at a screening visit and at the conclusion of the trial (approximately 36 months after their screening visit). Compliance and safety will be monitored by clinic visits.