People with diabetes are 25-times more likely to lose vision than those without. The tight glucose control that can prevent the development of diabetic eye disease (retinopathy) is often difficult to achieve, and even if it is, retinopathy can still develop.  In people with Type 2 diabetes a once daily specific blood fat lowering tablet fenofibrate can substantially predict against the progression of eye damage, independent of blood fat levels. Fenofibrate also protects against diabetic kidney and nerve damage.  FAME-1 Eye is the first trial in Type 1 diabetes and aims to determine at least 3-years of fenofibrate can also protect against eye damage in adults with existent early retinopathy. Results, if positive can be immediately used in clinical practice.  

 

Trial Summary:

FAME 1 Eye is a multicentre double-blind, placebo-controlled, randomised trial, with a 6 week run-in period prior to randomisation. Study treatment is Fenofibrate 145mg or placebo once daily. Participants will be followed up 3-6 monthly after randomisation for clinical, outcome and safety review for at least 3 years on average, followed by an 8 weeks wash-out period. The trial is run through 20-25 centres in ANZ and international (Hong Kong and Northern Ireland) and has started recruiting since end of 2016.

Supported By:

NHMRC & JDRF Australia; Mylan Pharmaceuticals Europe (Former Abbott)

Eligibility:

Men and women aged >=18 with type 1 diabetes (T1D) and non-proliferative diabetic retinopathy (NPDR) with ETDRS score 35-53.

Registration ID:

ACTRN12611000249954 & NCT01320345

Participation:

At least 450 participants in ANZ and international

Australian Lead Group:

NHMRC CTC

Status:

Recruiting

Activation Date:

 

Chairs:

 

Contact:

fame1eye@ctc.usyd.edu.au