The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
- Conditions
- Type 1 Diabetes MellitusDiabetic RetinopathyDiabetic Nephropathies
- Interventions
- Registration Number
- NCT01320345
- Lead Sponsor
- University of Sydney
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fenofibrate Fenofibrate 145 mg tablet of fenofibrate administered daily for 36 months. Placebo Inert lactose placebo Inert lactose tablet (otherwise matching active) administered daily for 36 months.
- Primary Outcome Measures
Name Time Method Occurrence of clinical significant retinopathy progression. As reported throughout the study and/or annual eye assessment post-randomisation Comprising 2-step progression of ETDRS score (to at least moderately severe grade), clinically significant macular oedema, need for laser surgery, need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy, adjudicated to be for diabetic retinopathy (DR)
- Secondary Outcome Measures
Name Time Method The individual components of the primary endpoint At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). Clinically significant retinopathy progression, 2-step progression of ETDRS score
Occurrence of clinically significant macula oedema (CSME). As reported throughout the study Occurrence of clinically significant macula oedema (CSME) per standard ophthalmological assessment or laser therapy.
Need for laser surgery for DR As reported throughout the study Need for laser surgery for DR
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy As reported throughout the study Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy for DR
Visual acuity. At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). Visual acuity using ETDRS/LogMar or Snellen Chart
Macular volume and thickness At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). Macular volume and thickness by Optical Coherence Tomography (OCT)
Albuminuria. At baseline, 12 m post-randomisation, 24 m post-randomisation, the end of study visit (which is on average 36 months post-randomisation) and wash-out visit. Albuminuria measured as urinary albumin:creatinine ratio.
Estimated glomerular filtration rate. At study completion and washout visit Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula.
Peripheral neuropathy status At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). Peripheral neuropathy status assessed by temperature \& vibration sensation and monofilament test.
Autonomic neuropathy. At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). Autonomic neuropathy (QTc and R-R intervals) on annual ECGs.
Total cardiovascular events. As reported throughout the study. Total cardiovascular events including myocardial infarction, stroke, sudden cardiac death, hospitalisation for acute coronary syndrome or any revascularisation events.
Frequency of foot ulcer and non-traumatic amputation. As reported throughout the study Foot ulcer and/or non-traumatic amputation are reported by site during the study.
Trial Locations
- Locations (23)
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Southern Adelaide Diabetes and Endocrine Services
🇦🇺Oaklands Park, South Australia, Australia
Auckland Diabetes Centre
🇳🇿Auckland, New Zealand
St Vincent's Hospital Melbourne
🇦🇺Melbourne, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Retina Associates - South West Retina
🇦🇺Liverpool, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Garvan Institute of Medical Research
🇦🇺Darlinghurst, New South Wales, Australia
Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
University Hospital Geelong
🇦🇺Geelong, Victoria, Australia
Heidelberg Repatriation Hospital
🇦🇺Heidelberg, Victoria, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
Baker Heart and Diabetes Institute
🇦🇺Melbourne, Victoria, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Belfast Health and Social Care Trust
🇬🇧Belfast, United Kingdom
Prince of Wales Hospital
ðŸ‡ðŸ‡°Shatin, New Territories, Hong Kong