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Clinical Trial Details

The Fenofibrate And Microvascular Events in Type 1 diabetes Eye: A randomised trial to evaluate the efficacy on retinopathy and safety of fenofibrate in adults with type 1 diabete. A multicentre double-blind placebo-controlled study in Australia and internationally

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Trial Information

Broad Health Condition Eye
Metabolic and Endocrine
Renal and Urogenital

Specific Health ConditionDiseases / disorders of the eye
Diabetes
Kidney disease

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC

Hospital
Hunter Diabetes Centre - Merewether
Royal Prince Alfred Hospital - Camperdown
Royal North Shore Hospital - St Leonards
Concord Repatriation Hospital - Concord
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Barwon Health - Geelong Hospital campus - Geelong
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Baker Heart and Diabetes Institute - Melbourne
Princess Alexandra Hospital - Woolloongabba
The Royal Adelaide Hospital - Adelaide
Fremantle Hospital and Health Service - Fremantle
Prince of Wales Hospital - Randwick
Royal Melbourne Hospital - City campus - Parkville
The Canberra Hospital - Garran
Cairns Base Hospital - Cairns
Garvan Institute of Medical Research - Darlinghurst
Southern Adelaide Diabetes and Endocrine Services - Oaklands Park
Mater Adult Hospital - South Brisbane
Sunshine Hospital - St Albans
South West Retina Liverpool - Liverpool


Postcode
2170 - Liverpool
2291 - Merewether
2050 - Camperdown
2065 - St Leonards
2139 - Concord
3065 - Fitzroy
3220 - Geelong
3081 - Heidelberg West
3004 - Melbourne
4102 - Woolloongabba
5000 - Adelaide
6160 - Fremantle
2031 - Randwick
5046 - Oaklands Park
3050 - Parkville
2605 - Garran
4870 - Cairns
2170 - Liverpool South
2010 - Darlinghurst
4101 - South Brisbane
3021 - St Albans


Trial location outside Australia
New ZealandChristchurch, Auckland
Hong KongShatin, New Territories

Anticipated date of first participant enrolment1/09/2011

Anticipated date of last participant enrolment1/09/2011

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Trial 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.
Eligibility

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) Documented history of T1D related autoantibody/ies (anti-GAD, anti-A2, anti-ZnT8).

2) Age 18 years or over;
3) eGFR must exceed 30 ml/min/1.73m2;
4) Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.;
5) All types of insulin therapy, with no restriction by level of HbA1c;
6) Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
7) Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study.

Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

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 diabetic retinopathy;
4) Prior bilateral intra-ocular injection(s) within the last 6 months;
5) Bilateral cataract surgery within the last 6 months;
6) Planned bilateral cataract surgery within the next 12 months;
7) History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
8) History of photosensitive skin rash or myositis; 
9) Abnormal thyroid function (untreated);
10) Liver function tests exceeding 3xULN;
11) Persistent elevated unexplained blood CPK level above normal range;
12) Documented fasting TG levels >6.5 mmol/L;
13) History of pancreatitis, DVT or pulmonary embolism;
14) Use of investigational drugs in the prior 8 weeks;
15) Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis; 
16) MI, unstable angina, stroke or heart failure within last 6 months;
17) Diagnosed cancer with ongoing treatment or prognosis anticipated at <5 years;
18) Any obstacle to regular follow-up including scheduled clinic attendances;
19) Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: NHMRC Clinical Trials Centre, University of Sydney
Primary Sponsor Address: Medical Foundation Building 92-94 Parramatta Road, Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial websitehttps://ctc.usyd.edu.au/our-work/research-divisions/diabetes/current-research/fame-1-eye-trial/

Trial IDACTRN12611000249954

Contact person for information and recruitmentMrs
Liping Li
Medical Foundation Building 92-94 Parramatta Road Camperdown NSW 2050
+61 2 9562 5000

Further information iconfame1eye.study@sydney.edu.au
Australia