Type 1 Diabetes MellitusPhase 3FAME 1 EYENCT01320345
The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.
A Phase 3 study testing Fenofibrate in people with Type 1 Diabetes Mellitus and Diabetic Retinopathy, run by University of Sydney at 24 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetic Retinopathy, Diabetic Nephropathies
- What is being tested?
- Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 3 Nov 2016to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-Glutamic acid decarboxylase, anti-A2, anti-ZnT8).
- Age 18 years or over;
- Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
- 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.;
- All types of insulin therapy, with no restriction by level of HbA1c;
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- Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
- 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.
Who cannot join
- Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.);
- 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);
- Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
- Prior bilateral intra-ocular injection(s) within the last 6 months;
- Bilateral cataract surgery within the last 6 months;
- Planned bilateral cataract surgery within the next 12 months;
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- History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
- History of photosensitive skin rash or myositis;
- Abnormal thyroid function (untreated);
- Liver function tests exceeding 3x upper limit of normal (ULN);
- Persistent elevated unexplained blood creatinine phosphokinase level above normal range;
- Documented fasting triglycerides (TG) levels >6.5 mmol/L;
- History of pancreatitis, deep vein thrombosis (DVT) or pulmonary embolism;
- Use of investigational drugs in the prior 8 weeks;
- Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis;
- Myocardial infarction (MI), unstable angina, stroke or heart failure within last 6 months;
- Diagnosed cancer with ongoing treatment or prognosis anticipated at <5 years;
- Any obstacle to regular follow-up including scheduled clinic attendances;
- Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Australia20 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Cairns Hospital
Cairns, Queensland, 4870
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Garvan Institute of Medical Research
Darlinghurst, New South Wales, 2010
Fremantle Hospital
Fremantle, Western Australia, 6160
Canberra Hospital
Garran, Australian Capital Territory, 2605
University Hospital Geelong
Geelong, Victoria, 3220
Heidelberg Repatriation Hospital
Heidelberg, Victoria, 3081
Retina Associates - South West Retina
Liverpool, New South Wales, 2170
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Hunter Diabetes Centre
Merewether, New South Wales, 2291
Southern Adelaide Diabetes and Endocrine Services
Oaklands Park, South Australia, 5046
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Prince of Wales Hospital
Randwick, New South Wales, 2032
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Mater Adult Hospital
South Brisbane, Queensland, 4101
Sunshine Hospital
St Albans, Victoria, 3021
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand2 sites
Auckland Diabetes Centre
Auckland, 1051
Christchurch Hospital
Christchurch, 8011
United Kingdom1 site
Belfast Health and Social Care Trust
Belfast, BT12 6BA
About this study
Official title: 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.
The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy.
Read the detailed description
Diabetes is the most common cause of adult onset blindness. Irreversible vision loss is a most feared complication of diabetes. Fenofibrate is a blood fat lowering drug available in Australia and 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 oral Fenofibrate 145mg once daily for average 36 months in 450 adults with Type 1 diabetes mellitus who are at high risk of eye damage.
- Being tested
- Fenofibrate, Inert lactose placebo
- Keywords
- Diabetes Mellitus, Type 1 Diabetes Mellitus, Retinopathy, Diabetic Nephropathy, Fenofibrate
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy, Diabetic Nephropathies, Diabetes Mellitus, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
145 mg tablet of fenofibrate administered once daily for 36 months.
Inert lactose placeboDrug
Insert lactose tablet matching active tablet administered once daily for 36 months.
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Experimental | 145 mg tablet of fenofibrate administered daily for 36 months. Receives: Drug: Fenofibrate |
| Placebo | Placebo comparator | Inert lactose tablet (otherwise matching active) administered daily for 36 months. Receives: Drug: Inert lactose placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of clinical significant retinopathy progression.
Comprising 2-step progression of ETDRS score (to at least moderately severe grade), clinically significant macular oedema, need for laser surgery, need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy, adjudicated to be for diabetic retinopathy (DR)
Measured: As reported throughout the study and/or annual eye assessment post-randomisation
Secondary outcomes (12)
The individual components of the primary endpoint
Clinically significant retinopathy progression, 2-step progression of ETDRS score
Measured: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Occurrence of clinically significant macula oedema (CSME).
Occurrence of clinically significant macula oedema (CSME) per standard ophthalmological assessment or laser therapy.
Measured: As reported throughout the study
Need for laser surgery for DR
Need for laser surgery for DR
Measured: As reported throughout the study
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy for DR
Measured: As reported throughout the study
Visual acuity.
Visual acuity using ETDRS/LogMar or Snellen Chart
Measured: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Macular volume and thickness
Macular volume and thickness by Optical Coherence Tomography (OCT)
Measured: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Albuminuria.
Albuminuria measured as urinary albumin:creatinine ratio.
Measured: At baseline, 12 m post-randomisation, 24 m post-randomisation, the end of study visit (which is on average 36 months post-randomisation) and wash-out visit.
Estimated glomerular filtration rate.
Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula.
Measured: At study completion and washout visit
Peripheral neuropathy status
Peripheral neuropathy status assessed by temperature \& vibration sensation and monofilament test.
Measured: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Autonomic neuropathy.
Autonomic neuropathy (QTc and R-R intervals) on annual ECGs.
Measured: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Total cardiovascular events.
Total cardiovascular events including myocardial infarction, stroke, sudden cardiac death, hospitalisation for acute coronary syndrome or any revascularisation events.
Measured: As reported throughout the study.
Frequency of foot ulcer and non-traumatic amputation.
Foot ulcer and/or non-traumatic amputation are reported by site during the study.
Measured: As reported throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study start3 Nov 2016
- Primary completion28 Aug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Juvenile Diabetes Research Foundation Australia, Mylan Pharmaceuticals Inc
- Responsible party
- Sponsor
- Investigators
- Anthony Keech, Professor, Principal investigator, NHMRC Clinical Trials Centre, The University of SydneyAlicia Jenkins, Professor, Principal investigator, NHMRC Clinical Trials Centre, The University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320345
- Sponsor's protocol ID
- FAME0001
- Other IDs
- ACTRN12611000249954
- Acronym
- FAME 1 EYE
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2011
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01320345
- Acronym / sponsor ID
- FAME 1 EYE / FAME0001
- Keywords
- Diabetes Mellitus, Type 1 Diabetes Mellitus, Retinopathy, Diabetic Nephropathy, Fenofibrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 412 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Juvenile Diabetes Research Foundation Australia, Mylan Pharmaceuticals Inc
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy.
Detailed description
Diabetes is the most common cause of adult onset blindness. Irreversible vision loss is a most feared complication of diabetes. Fenofibrate is a blood fat lowering drug available in Australia and 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 oral Fenofibrate 145mg once daily for average 36 months in 450 adults with Type 1 diabetes mellitus who are at high risk of eye damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Experimental | Drug: Fenofibrate145 mg tablet of fenofibrate administered daily for 36 months. |
| Placebo | Placebo comparator | Drug: Inert lactose placeboInert lactose tablet (otherwise matching active) administered daily for 36 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria:
- Age 18 years or over;
- Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
- 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.;
- All types of insulin therapy, with no restriction by level of HbA1c;
Key exclusion criteria (19 listed)
- Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.);
- 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);
- Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
- Prior bilateral intra-ocular injection(s) within the last 6 months;
- Bilateral cataract surgery within the last 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate145 mg tablet of fenofibrate administered once daily for 36 months. | Drug | Fenofibrate |
| Inert lactose placeboInsert lactose tablet matching active tablet administered once daily for 36 months. | Drug | Placebo |
Primary outcome
Occurrence of clinical significant retinopathy progression.
Time frame: As reported throughout the study and/or annual eye assessment post-randomisation
Comprising 2-step progression of ETDRS score (to at least moderately severe grade), clinically significant macular oedema, need for laser surgery, need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy, adjudicated to be for diabetic retinopathy (DR)
12 secondary outcomes
The individual components of the primary endpoint
Time frame: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Occurrence of clinically significant macula oedema (CSME).
Time frame: As reported throughout the study
Need for laser surgery for DR
Time frame: As reported throughout the study
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy
Time frame: As reported throughout the study
Visual acuity.
Time frame: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Macular volume and thickness
Time frame: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Albuminuria.
Time frame: At baseline, 12 m post-randomisation, 24 m post-randomisation, the end of study visit (which is on average 36 months post-randomisation) and wash-out visit.
Estimated glomerular filtration rate.
Time frame: At study completion and washout visit
Peripheral neuropathy status
Time frame: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Autonomic neuropathy.
Time frame: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).
Total cardiovascular events.
Time frame: As reported throughout the study.
Frequency of foot ulcer and non-traumatic amputation.
Time frame: As reported throughout the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Keech, Professor principal investigator
NHMRC Clinical Trials Centre, The University of Sydney
Alicia Jenkins, Professor principal investigator
NHMRC Clinical Trials Centre, The University of Sydney
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fenofibrate in people with Type 1 Diabetes Mellitus and Diabetic Retinopathy, run by University of Sydney at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Australia, New Zealand, Hong Kong, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of clinical significant retinopathy progression. (time frame: As reported throughout the study and/or annual eye assessment post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.