The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 300
Summary
- Conditions
- Diabetic Nephropathies
- Diabetic Retinopathy
- Type 1 Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT01320345
- Collaborators
- National Health and Medical Research Council, Australia
- Juvenile Diabetes Research Foundation Australia
- Mylan Pharmaceuticals
- Investigators
- Principal Investigator: Anthony Keech, Professor NHMRC Clinical Trials Centre, The University of Sydney Principal Investigator: Alicia Jenkins, Professor NHMRC Clinical Trials Centre, The University of Sydney
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