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The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2016-11-03
Primary completion: 2024-12-01
Study completion finish: 2025-12-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT01320345
Intervention or treatment
DRUG: Fenofibrate
DRUG: Inert lactose placebo
Conditions
- • Type 1 Diabetes Mellitus
- • Diabetic Retinopathy
- • Diabetic Nephropathies
Find a site
Closest Location:
Canberra Hospital
Research sites nearby
Select from list below to view details:
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Fenofibrate
| DRUG: Fenofibrate
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Inert lactose placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Occurrence of clinical significant retinopathy progression. | 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) | As reported throughout the study and/or annual eye assessment post-randomisation |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
The individual components of the primary endpoint | Clinically significant retinopathy progression, 2-step progression of ETDRS score | At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). |
Occurrence of clinically significant macula oedema (CSME). | Occurrence of clinically significant macula oedema (CSME) per standard ophthalmological assessment or laser therapy. | As reported throughout the study |
Need for laser surgery for DR | Need for laser surgery for DR | As reported throughout the study |
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy | Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy for DR | As reported throughout the study |
Visual acuity. | Visual acuity using ETDRS/LogMar or Snellen Chart | 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 | Macular volume and thickness by Optical Coherence Tomography (OCT) | At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). |
Albuminuria. | Albuminuria measured as urinary albumin:creatinine ratio. | 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. |
Estimated glomerular filtration rate. | Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula. | At study completion and washout visit |
Peripheral neuropathy status | Peripheral neuropathy status assessed by temperature \& vibration sensation and monofilament test. | 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. | Autonomic neuropathy (QTc and R-R intervals) on annual ECGs. | At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation). |
Total cardiovascular events. | Total cardiovascular events including myocardial infarction, stroke, sudden cardiac death, hospitalisation for acute coronary syndrome or any revascularisation events. | As reported throughout the study. |
Frequency of foot ulcer and non-traumatic amputation. | Foot ulcer and/or non-traumatic amputation are reported by site during the study. | As reported throughout the study |
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