A Trial in Adults With Type 1 Diabetes Mellitus Evaluating the Effects of Fenofibrate Versus Placebo on Macular Thickness and Volume
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2011 |
| End Date: | September 2014 |
| Contact: | Anthony Keech, Professor |
| Email: | tony@ctc.usyd.edu.au |
| Phone: | +61 2 95625003 |
The Fenofibrate And Microvascular Event Eye (FAME 1 EYE) Trial: A Randomised Trial in Adults With Type 1 Diabetes Mellitus Evaluating the Effects of Daily Oral Fenofibrate Compared With Placebo on Macular Thickness and Volume
The purpose of this study is to evaluate the potential benefits of Fenofibrate in 300 adults
with Type 1 diabetes mellitus who are at high risk of eye damage.
with Type 1 diabetes mellitus who are at high risk of eye damage.
Diabetes is the commonest cause of adult onset blindness. Vision loss, which is
irreversible, is a most feared complication of diabetes. A blood fat lowering drug called
fenofibrate, available in Australia, 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 12 months in
300 adults with Type 1 diabetes mellitus who are at high risk of eye damage.
irreversible, is a most feared complication of diabetes. A blood fat lowering drug called
fenofibrate, available in Australia, 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 12 months in
300 adults with Type 1 diabetes mellitus who are at high risk of eye damage.
Inclusion Criteria:
- Subjects with type 1 diabetes mellitus
- Over 18 years of age
- Established macular thickening on optical coherence tomography (OCT) greater than or
equal to 300 micrometres in at least one macular zone
- No definite indication for receiving, and no contraindication to receiving
fenofibrate in addition to their existing therapy
Exclusion Criteria:
- Subjects with type 1 diabetes mellitus and the contraindications of definite need for
intra-ocular treatment or photocoagulation therapy within next 3 months
- Allergy to any fibrate drugs
- History of pancreatitis or pulmonary embolism or DVT
- Use of any other investigational agents in last 8 weeks
- Unstable condition including recent MI, heart failure, prior organ transplant, severe
renal or liver dysfunction, history of myositis or untreated hypothyroidism
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