Active not recruitingPHASE3INTERVENTIONAL

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

This important study is investigating a medication called fenofibrate to see if it can help protect the eyes of adults living with Type 1 diabetes. Eye damage is a serious and feared complication of diabetes, and finding ways to prevent it is crucial. Fenofibrate is a medicine that helps lower fats in the blood and has previously shown promise in reducing eye damage in people with Type 2 diabetes. This research aims to find out if taking 145 mg of fenofibrate every day can offer similar protection for those with Type 1 diabetes who already have some early signs of eye changes. Around 450 adults will take part for about three years to see if this treatment can make a difference.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Sydney

Enrolment target

412

Start

03 Nov 2016

Estimated completion

01 Dec 2026

Type 1 Diabetes Mellitus Diabetic Retinopathy Diabetic Nephropathies

What is this study about?

Diabetes is a condition that affects many parts of the body, and unfortunately, it's the most common reason why adults might lose their eyesight. Losing your sight can be very worrying, and doctors are always looking for ways to prevent this from happening.

This study is looking at a medicine called fenofibrate. This medicine is already used to help lower fats in the blood. Previous studies have shown that fenofibrate might help reduce eye damage in people with Type 2 diabetes. It has also shown positive results in protecting the eyes of animals with Type 1 diabetes.

The main goal of this research is to see if taking 145 mg of fenofibrate once a day can help prevent or slow down eye damage in adults who have Type 1 diabetes and some early signs of eye problems. Participants will be involved for about three years, and doctors will carefully monitor their eye health to see if the fenofibrate makes a difference. The study will compare those taking fenofibrate with those taking a dummy pill (placebo) to understand its real effects.

Key takeaways

This study investigates if fenofibrate can protect eyes in Type 1 diabetes.
Eye damage is a serious concern for people with diabetes.
Fenofibrate is a daily tablet already used to lower fats in the blood.
The study involves adults aged 18+ with Type 1 diabetes and early eye changes.
Participation lasts about three years and includes regular eye checks.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older with Type 1 diabetes. Your diabetes diagnosis must meet specific criteria, which your doctor can help you understand. You also need to have healthy kidney function and some early signs of eye changes (called non-proliferative diabetic retinopathy), which will be checked with eye photographs.

There are also some reasons why you might not be able to join. For example, if you already have a clear need for or reason not to take fenofibrate, or if you need certain eye treatments within the next three months. Other medications for cholesterol, like statins, are generally allowed. The study is open to both men and non-pregnant women who are using reliable contraception.

Quick self-check

Are you 18 years old or older?
Do you have Type 1 diabetes?
Do you have good kidney function?
Have you been told you have early signs of eye changes from diabetes (non-proliferative retinopathy)?
Are you able to attend regular clinic appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take either fenofibrate or a dummy pill (placebo) once a day for about three years. You will have regular appointments at the clinic for assessments, which will include eye checks and other health evaluations. It's important that you're able to come to these appointments and follow the study instructions carefully. Before you decide, you'll get detailed information about what's involved and will need to give your written consent.

Potential risks and benefits

Participating in this study might offer the potential benefit of protecting your eyes from further damage due to Type 1 diabetes. However, fenofibrate, like any medication, can have side effects, which the study team will explain in detail. There's also a chance you might receive the dummy pill, which won't directly treat your eyes but helps researchers understand the real effect of the active drug. You are free to withdraw from the study at any time without affecting your medical care.

Locations (24)

Canberra Hospital
Garran, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Concord Repatriation General Hospital
Concord, Australia
Garvan Institute of Medical Research
Darlinghurst, Australia
Retina Associates - South West Retina
Liverpool, Australia
Hunter Diabetes Centre
Merewether, Australia
Prince of Wales Hospital
Randwick, Australia
Royal North Shore Hospital
Saint Leonards, Australia
Cairns Hospital
Cairns, Australia
Mater Adult Hospital
South Brisbane, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Royal Adelaide Hospital
Adelaide, Australia

+12 more sites — see the official record for the full list.

Common questions

What is Type 1 diabetes?

Type 1 diabetes is a condition where your body stops making insulin, a hormone needed to turn sugar into energy. People with Type 1 diabetes need to take insulin every day.

What is diabetic retinopathy?

Diabetic retinopathy is an eye condition that can happen to people with diabetes. High blood sugar levels can damage the small blood vessels in the retina, the light-sensing part at the back of your eye.

What is fenofibrate?

Fenofibrate is a medicine often used to lower high levels of fats (like cholesterol and triglycerides) in the blood. It's hoped it might also help protect eyes in people with diabetes.

Will I know if I'm getting the real medicine or the dummy pill?

No, this is a 'blinded' study, meaning neither you nor your doctor will know if you're taking fenofibrate or the placebo until the study is over. This helps ensure fair results.

How long will the study last?

If you take part, you will be involved for approximately three years, with regular check-ups during that time.