The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye. (FAME 1 EYE)

January 15, 2026 updated by: University of Sydney

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Garvan Institute of Medical Research
      • Liverpool, New South Wales, Australia, 2170
        • Retina Associates - South West Retina
      • Merewether, New South Wales, Australia, 2291
        • Hunter Diabetes Centre
      • Randwick, New South Wales, Australia, 2032
        • Prince of Wales Hospital
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Cairns Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes and Endocrine Services
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • University Hospital Geelong
      • Heidelberg, Victoria, Australia, 3081
        • Heidelberg Repatriation Hospital
      • Melbourne, Victoria, Australia, 3004
        • Baker Heart and Diabetes Institute
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • New Zealand
      • Auckland, New Zealand, 1051
        • Auckland Diabetes Centre
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Belfast Health and Social Care Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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-Glutamic acid decarboxylase, anti-A2, anti-ZnT8).
  2. Age 18 years or over;
  3. Estimated glomerular filtration rate (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.

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 3x upper limit of normal (ULN);
  11. Persistent elevated unexplained blood creatinine phosphokinase level above normal range;
  12. Documented fasting triglycerides (TG) levels >6.5 mmol/L;
  13. History of pancreatitis, deep vein thrombosis (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. Myocardial infarction (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fenofibrate
145 mg tablet of fenofibrate administered daily for 36 months.
Drug: Fenofibrate
145 mg tablet of fenofibrate administered once daily for 36 months.
Placebo Comparator: Placebo
Inert lactose tablet (otherwise matching active) administered daily for 36 months.
Drug: Inert lactose placebo
Insert lactose tablet matching active tablet administered once daily for 36 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
As reported throughout the study and/or annual eye assessment post-randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Clinically significant retinopathy progression, 2-step progression of ETDRS score
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
Occurrence of clinically significant macula oedema (CSME) per standard ophthalmological assessment or laser therapy.
As reported throughout the study
Need for laser surgery for DR
Time Frame: As reported throughout the study
Need for laser surgery for DR
As reported throughout the study
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy
Time Frame: As reported throughout the study
Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy for DR
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).
Visual acuity using ETDRS/LogMar or Snellen Chart
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).
Macular volume and thickness by Optical Coherence Tomography (OCT)
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.
Albuminuria measured as urinary albumin:creatinine ratio.
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
Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula.
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).
Peripheral neuropathy status assessed by temperature & vibration sensation and monofilament test.
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).
Autonomic neuropathy (QTc and R-R intervals) on annual ECGs.
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.
Total cardiovascular events including myocardial infarction, stroke, sudden cardiac death, hospitalisation for acute coronary syndrome or any revascularisation events.
As reported throughout the study.
Frequency of foot ulcer and non-traumatic amputation.
Time Frame: As reported throughout the study
Foot ulcer and/or non-traumatic amputation are reported by site during the study.
As reported throughout the study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lipid and lipoprotein levels
Time Frame: At baseline and end of study
Lipid and lipoprotein levels
At baseline and end of study
Biomarkers and molecular markers
Time Frame: At baseline and end of study
Markers of inflammation, glycation and oxidative stress, angiogenesis and adipocyte function, and molecular markers, as change from baseline with study treatment
At baseline and end of study
Quality of Life questionnaire
Time Frame: At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit
Quality of Life questionnaire completed by participants annually
At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sydney

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health and Medical Research Council, Australia
Mylan Pharmaceuticals Inc
Juvenile Diabetes Research Foundation Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Keech, Professor, NHMRC Clinical Trials Centre, The University of Sydney
  • Principal Investigator: Alicia Jenkins, Professor, NHMRC Clinical Trials Centre, The University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FAME0001
  • ACTRN12611000249954 (Registry Identifier: Australian New Zealand Clinical Trials Registry (ANZCTR))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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