FAME 1 Eye
Research type
Research Study
Full title
The Fenofibrate And Microvascular Events in Type 1 diabetes Eye (FAME 1 Eye): A randomised trial to evaluate the efficacy on retinopathy and safety of fenofibrate in adults with type 1 diabetes. A multicentre double-blind placebo-controlled study in Australia and internationally
IRAS ID
236169
Contact name
Philip Johnston
Contact email
Sponsor organisation
Belfast Health & Social Care Trust
Eudract number
2019-002591-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 31 days
Research summary
Diabetes is the most common cause of adult-onset vision loss, due to damage to the back of the eye which worsens over time (progressive diabetic retinopathy). Diabetes can also lead to other blood vessel damage, including heart and kidney disease, foot ulcers and amputations. Current treatments are not fully effective at preventing worsening of these conditions. Fenofibrate is a usually well-tolerated drug, taken as a tablet that has proven to be of benefit in retinopathy progression in adults with type 2 diabetes (T2D).
The main purpose of this study is to investigate whether treatment with fenofibrate reduces the risk of progression of diabetic eye disease (retinopathy) in people with T1D. Other important purposes of the study are to determine whether treatment with fenofibrate reduces the risk of people with T1D developing vascular complications such as renal disease, nerve disease, heart attack and other cardiovascular disease (CVD), and to identify whether retinal photographic changes and specific blood markers can predict important clinical outcomes.
It is planned that up to 450 or more participants will take part in this study in Australia and internationally. Many clinical centres with affiliated ophthalmologists treating adult patients with T1D will be involved. Over 20 eligible participants may be recruited in each centre.
Both men and non-pregnant women aged 18 years or over with T1D and mild diabetic eye disease, will be invited to join the study. After eligibility checking and 6 weeks of run-in period, they will be centrally randomised to take fenofibrate 145mg daily or placebo and followed up 3-6 monthly for average 3 years to its main outcomes.REC name
HSC REC A
REC reference
19/NI/0185
Date of REC Opinion
29 May 2020
REC opinion
Further Information Favourable Opinion