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Trial registered on ANZCTR
Registration number
ACTRN12611000249954
Ethics application status
Approved
Date submitted
7/03/2011
Date registered
7/03/2011
Date last updated
16/01/2024
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
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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Scientific title
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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Secondary ID [1]
259745
0
N/A
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Universal Trial Number (UTN)
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Trial acronym
FAME1 Eye
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eye disease (retinopathy) in type 1 diabetes mellitus
261330
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Diabetic nephropathy in type 1 diabetes mellitus
261331
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Condition category
Condition code
Eye
259475
259475
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0
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Diseases / disorders of the eye
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Metabolic and Endocrine
259476
259476
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0
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Diabetes
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Renal and Urogenital
259477
259477
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
Concurrent to the main study a small number of age and gender matched nondiabetic reference group participants will provide blood and urine samples for comparison research at a screening visit and at the conclusion of the trial (approximately 36 months after their screening visit).
Compliance and safety will be monitored by clinic visits.
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Intervention code [1]
264177
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Treatment: Drugs
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Comparator / control treatment
Participants randomised to the placebo arm will take a matched, once daily inert lactose tablet for 36 months.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
262287
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Timepoint [1]
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As reported throughout the study and/or annual eye assessment with retinal photography completed 12 monthly for average of 3 years post-randomisation
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Secondary outcome [1]
273462
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Albuminuria measured as urinary albumin:creatinine ratio.
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Assessment method [1]
273462
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Timepoint [1]
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At baseline, date of randomisation, 3 m post-randomisation, 12 m post-randomisation, 24 m post randomisation, end of study visit and wash-out visit.
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Secondary outcome [2]
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Visual acuity using Snellen Chart
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Assessment method [2]
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Timepoint [2]
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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Secondary outcome [3]
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Corneal confocal microscopic measurement of neural damage (only assessed in a representative subset of the participants at sites with the specialised confocal microscope).
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Assessment method [3]
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Timepoint [3]
273464
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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Secondary outcome [4]
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Estimated glomerular filtration rate using MDRD formula
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Assessment method [4]
273465
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Timepoint [4]
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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Secondary outcome [5]
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Peripheral neuropathy status assessed by temperature sensation and monofilament sensation.
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Assessment method [5]
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Timepoint [5]
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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Secondary outcome [6]
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Blood lipids and biomarkers in plasma
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Assessment method [6]
273468
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Timepoint [6]
273468
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At baseline, 12 m post-randomisation, 24 m post randomisation, end of study visit and wash-out visit.
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Secondary outcome [7]
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Total cardiovascular events including myocardial infarction, stroke, sudden cardiac death, hospitalisation for acute coronary syndrome or any revascularisation events. These events are reported during the study by site to the sponsor.
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Assessment method [7]
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Timepoint [7]
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As reported throughout the study.
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Secondary outcome [8]
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Frequency of foot ulcer and non-traumatic amputation. These events are reported during the study by site to the sponsor.
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Assessment method [8]
372450
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Timepoint [8]
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As reported throughout the study
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Secondary outcome [9]
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Macular volume measured by Optical Coherence Tomography (OCT).
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Assessment method [9]
372451
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Timepoint [9]
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On study completion.
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Secondary outcome [10]
372452
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Autonomic neuropathy (QTc and RR intervals) on annual ECGs.
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Assessment method [10]
372452
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Timepoint [10]
372452
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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Secondary outcome [11]
372453
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Occurrence of clinically significant macula oedema (CSME) measured by optical coherence tomography and retinal photography.
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Assessment method [11]
372453
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Timepoint [11]
372453
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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Secondary outcome [12]
372454
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Need for laser surgery for retinopathy reported during the study by site to the sponsor
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Assessment method [12]
372454
0
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Timepoint [12]
372454
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As reported throughout the study
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Secondary outcome [13]
372455
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Need for intraocular anti-VEGF injection for retinopathy reported during the study by site to the sponsor
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Assessment method [13]
372455
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Timepoint [13]
372455
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As reported throughout the study
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Secondary outcome [14]
372456
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Need for intraocular corticosteroid therapy for retinopathy reported during the study by site to the sponsor
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Assessment method [14]
372456
0
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Timepoint [14]
372456
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As reported throughout the study
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Secondary outcome [15]
372457
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Need for vitrectomy for retinopathy reported during the study by site to the sponsor
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Assessment method [15]
372457
0
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Timepoint [15]
372457
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As reported throughout the study
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Secondary outcome [16]
372458
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Macular thickness measured by Optical Coherence Tomography (OCT).
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Assessment method [16]
372458
0
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Timepoint [16]
372458
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At baseline, 12 m post-randomisation, 24 m post randomisation and the end of study visit.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by Flexetrials computer software.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic balanced randomisation.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/09/2011
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Actual
3/11/2016
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
450
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Accrual to date
357
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
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Recruitment hospital [1]
14181
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Hunter Diabetes Centre - Merewether
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Recruitment hospital [2]
14182
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
14183
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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Concord Repatriation Hospital - Concord
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Recruitment hospital [5]
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [6]
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [7]
14187
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Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment hospital [8]
14188
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment hospital [9]
14189
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [10]
14190
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [11]
14192
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Fremantle Hospital and Health Service - Fremantle
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Recruitment hospital [12]
14193
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Prince of Wales Hospital - Randwick
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Recruitment hospital [13]
21147
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [14]
21148
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The Canberra Hospital - Garran
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Recruitment hospital [15]
21149
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Cairns Base Hospital - Cairns
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Recruitment hospital [16]
21150
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Garvan Institute of Medical Research - Darlinghurst
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Recruitment hospital [17]
21151
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Southern Adelaide Diabetes and Endocrine Services - Oaklands Park
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Recruitment hospital [18]
21152
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [19]
21153
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Sunshine Hospital - St Albans
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Recruitment hospital [20]
21154
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South West Retina Liverpool - Liverpool
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Recruitment postcode(s) [1]
27160
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2170 - Liverpool
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Recruitment postcode(s) [2]
27161
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2291 - Merewether
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Recruitment postcode(s) [3]
27162
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2050 - Camperdown
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Recruitment postcode(s) [4]
27163
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2065 - St Leonards
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Recruitment postcode(s) [5]
27164
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2139 - Concord
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Recruitment postcode(s) [6]
27165
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3065 - Fitzroy
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Recruitment postcode(s) [7]
27166
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3220 - Geelong
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Recruitment postcode(s) [8]
27167
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3081 - Heidelberg West
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Recruitment postcode(s) [9]
27168
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3004 - Melbourne
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Recruitment postcode(s) [10]
27169
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4102 - Woolloongabba
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Recruitment postcode(s) [11]
27170
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5000 - Adelaide
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Recruitment postcode(s) [12]
27171
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6160 - Fremantle
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Recruitment postcode(s) [13]
27172
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2031 - Randwick
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Recruitment postcode(s) [14]
27173
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5046 - Oaklands Park
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Recruitment postcode(s) [15]
36007
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3050 - Parkville
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Recruitment postcode(s) [16]
36008
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2605 - Garran
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Recruitment postcode(s) [17]
36009
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4870 - Cairns
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Recruitment postcode(s) [18]
36010
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2170 - Liverpool South
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Recruitment postcode(s) [19]
36011
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2010 - Darlinghurst
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Recruitment postcode(s) [20]
36012
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4101 - South Brisbane
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Recruitment postcode(s) [21]
36013
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3021 - St Albans
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Recruitment outside Australia
Country [1]
21678
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New Zealand
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State/province [1]
21678
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Christchurch, Auckland
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Country [2]
24345
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Hong Kong
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State/province [2]
24345
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Shatin, New Territories
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Country [3]
26082
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United Kingdom
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State/province [3]
26082
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Belfast
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Funding & Sponsors
Funding source category [1]
264624
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Commercial sector/Industry
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Name [1]
264624
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Mylan EPD Europe
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Address [1]
264624
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Turmstrasse 24
6312 Steinhausen
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Country [1]
264624
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Switzerland
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Funding source category [2]
264625
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Government body
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Name [2]
264625
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National Health and Medical Research Council
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Address [2]
264625
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16 Marcus Clarke St,
Canberra ACT 2601
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Country [2]
264625
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Australia
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Funding source category [3]
303254
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Other Collaborative groups
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Name [3]
303254
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JDRF (Australia)
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Address [3]
303254
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Level 4, 80-84 Chandos St
St Leonards NSW 2065
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Country [3]
303254
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Australia
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Primary sponsor type
University
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Name
NHMRC Clinical Trials Centre, University of Sydney
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Address
Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
263762
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Address [1]
263762
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Country [1]
263762
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
266629
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Northern Sydney Local Health District HREC
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Ethics committee address [1]
266629
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Research Office
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards NSW 2065
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Ethics committee country [1]
266629
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Australia
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Date submitted for ethics approval [1]
266629
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24/11/2014
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Approval date [1]
266629
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29/01/2015
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Ethics approval number [1]
266629
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Summary
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.
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Trial website
https://ctc.usyd.edu.au/our-work/research-divisions/diabetes/current-research/fame-1-eye-trial/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Anthony Keech and Alicia Jenkins
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Address
32319
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Medical Foundation Building
92-94 Parramatta Road
Camperdown NSW 2050
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Country
32319
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Australia
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Phone
32319
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+61 2 9562 5000
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Fax
32319
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Email
32319
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[email protected]
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Contact person for public queries
Name
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Mrs Liping Li
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Address
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Medical Foundation Building
92-94 Parramatta Road
Camperdown NSW 2050
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Country
15566
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Australia
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Phone
15566
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+61 2 9562 5000
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Fax
15566
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Email
15566
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[email protected]
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Contact person for scientific queries
Name
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Prof Alicia Jenkins
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Address
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Medical Foundation Building
92-94 Parramatta Road
Camperdown NSW 2050
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Country
6494
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Australia
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Phone
6494
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+61 2 9562 5000
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Fax
6494
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Email
6494
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Trial data is confidential and will be kept private.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF