The Fenofibrate And Microvascular Events in Type 1 diabetes Eye (FAME 1 EYE) dataset

The University of Sydney

Dataset description

The estimated sample size is 450. Demographics, clinical characteristics and outcomes measures will be available from patients with type 1 diabetes. The purpose is to All timepoints points (baseline, 6-week, 3-month, 6-month, 1-year, 2-year, 3-year assessments) will be included in the dataset.
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Source Study


Commercial sector/Industry,Mylan EPD Europe

Scientific enquiries

Prof Alicia Jenkins

Brief Summary

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 fenofibrate in 450 adults with Type 1 diabetes who are at high risk of eye damage.

Key Inclusion Criteria

Eligibility criteria for the main study: 1) Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria: *T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with: i) Documented history of ketoacidosis, and/or ii) Documented history of very low or undetectable C-peptide (fasting <200 nmol/L or 0.2 pmol/L), and/or iii) Docum ....
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Key Exclusion Criteria

1) Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.); 2) Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months (this exclusion only applies to retinal laser photocoagulation treatment to the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion); 3) Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabet ....
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Can healthy volunteers participate?




Sample Size    450

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Diabetic nephropathy in type 1 diabetes mellitus , Eye disease (retinopathy) in type 1 diabetes mellitus

Condition code    Eye , Metabolic and Endocrine , Renal and Urogenital


Intervention code Treatment: Drugs

All eligible participants will complete a 6 week run-in phase comprising either a once daily tablet of 145 mg fenofibrate or matching (inert lactose) placebo. After completion of the run-in period participants will be immediately randomised to either a once daily tablet of 145 mg fenofibrate or placebo, taken for 36 months. Participants ineligible for the run-in phase will be followed up by an annual phone call and a clinic visit at the end of the follow up period for blood and urine sampling. C ....
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Control group Placebo

Participants randomised to the placebo arm will take a matched, once daily inert lactose tablet for 36 months.


Outcome: Occurrence of clinical significant retinopathy progression: this is a composite outcome of 2-step progression of ETDRS score (using retinal photography to at least moderately severe grade), or clinically significant macular oedema, or need for laser surgery, or need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy, (reported by site investigator) adjudicated to be for diabetic retinopathy (DR)
Timepoint: As reported throughout the study and/or annua ....

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The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see