The FAME 1 Trial: Protecting against eye damage in adults living with type 1 diabetes

Eye damage in people living with type 1 diabetes (T1D) 

People living with T1D are 25 times more likely to develop vision loss than those living without the condition. The strict control of blood glucose levels necessary for the prevention of diabetic eye disease (retinopathy) is often difficult to achieve. Further, even if blood glucose levels are tightly controlled, retinopathy may still develop.  

What is the FAME 1 trial? 

The FAME 1 (retinopathy and fenofibrate in Adults with Type 1 diabetes) Eye Trial is a multicentre clinical trial, led by Professors. Alicia Jenkins and Anthony Keech. It is designed to test the effectiveness of a drug called fenofibrate on the development of retinopathy in adults living with T1D. 

Fenofibrate has been shown to protect against the progression of eye disease in previous studies on people living with type 2 diabetes, as well as protecting against both diabetic kidney disease and nerve damage.   

FAME-1 Eye is the first trial which will now test the effectiveness of fenofibrate in people living with T1D. The trial aims to determine whether at least three years of fenofibrate can protect against eye damage in adults living with T1D with existent early retinopathy. The results, if positive, can be immediately used to improve lives by changing current clinical practice.  

How is the study being conducted? 

According to the study design, participants receive either a placebo or fenofibrate (used to lower bloods fats) once daily. Participants will be followed up every three to six months after the conclusion of the trial, for a period of at least three years. 

What impact does study hope to have for T1D? 

If this study shows positive results, fenofibrate can be immediately used to improve lives for Australians living with T1D by changing current clinical practice and helping to protect against a complication that many in the community currently face or may in future.  

How can I get involved or learn more about the study?

The trial has been recruiting participants since the end of 2016 and is taking place in 22 centres across Australia and New Zealand, with another two internationally (Hong Kong & Northern Ireland). Participants are currently being recruited at 20 sites in New South Wales, Queensland, South Australia, Western Australia, and Victoria. 

For more information on the trial, please refer here.

For full eligibility criteria for the FAME1 Eye Study please click here.