Hunter Diabetes Centre | Merewether, Australia
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About
The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy.
Full description
Diabetes is the most common cause of adult onset blindness. Irreversible vision loss is a most feared complication of diabetes. Fenofibrate is a blood fat lowering drug available in Australia and 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 oral Fenofibrate 145mg once daily for average 36 months in 450 adults with Type 1 diabetes mellitus who are at high risk of eye damage.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion criteria (for the main study):
Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria:
Age 18 years or over;
Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.;
All types of insulin therapy, with no restriction by level of HbA1c;
Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study.
Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D.
Exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
450 participants in 2 patient groups, including a placebo group
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Central trial contact
Liping Li
Data sourced from clinicaltrials.gov
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