A clinical trial to assess whether fenofibrate can protect against eye damage in early retinopathy in adults with type 1 diabetes
About this study
The purpose of this study is to investigate whether treatment with fenofibrate can reduce the risk of people with Type 1 Diabetes (T1D) suffering from progression of diabetic eye disease. This trial involves a 6-week run-in period before being randomised with the study drug (fenofibrate) or placebo once daily. Participants will be followed up every 3 to 6 months for at least 3 years on average.
Who can take part
You may be eligible to participate in this study because you have Type 1 Diabetes. To be eligible, you must:
- be aged 18 years or over;
- have type 1 diabetes (T1D) confirmed by your diabetes doctor;
- have mild diabetic eye disease (retinopathy);
- not be currently participating in any other investigational drug study;
- undergo a screening visit where tests such as vitals, weight, height, bloods and an eye test will be undertaken
If you are a woman, you must not participate in the study if you are pregnant or breast feeding or if there is a chance that you may become pregnant during the period of the study.
What's involved
This study involves at least 11 visits over a 3-4 year period. If you are eligible to participate, you will be randomised to receive treatment with either fenofibrate or placebo and then asked to make regular 3-6 monthly visits to the research clinic where similar tests to that of the screening visit will be repeated.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.