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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01320345
Recruitment Status : Recruiting
First Posted : March 22, 2011
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Juvenile Diabetes Research Foundation Australia
Mylan Pharmaceuticals
Information provided by (Responsible Party):
University of Sydney

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Diabetic Retinopathy Diabetic Nephropathies Drug: Fenofibrate Drug: Inert lactose placebo Phase 3

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 12 months in 300 adults with Type 1 diabetes mellitus who are at high risk of eye damage. 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 3, 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Occurrence of clinical significant retinopathy progression. [ 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 clinical significant retinopathy progression, defined as a 2-step progression


Secondary Outcome Measures :
  1. Albuminuria. [ Time Frame: At baseline, date of randomisation, 3 m post-randomisation, 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.

  2. 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 Snellen Chart.

  3. Corneal nerve damage. [ 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). ]
    Corneal confocal microscopic measurement of neural damage (only assessed in a representative subset of the participants at sites with the specialised confocal microscope).

  4. Estimated glomerular filtration rate. [ 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). ]
    Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula.

  5. Peripheral neuropathy status.sensation. [ 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 sensation and monofilament sensation.

  6. Vascular function. [ 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). ]
    Vascular function using non-invasive pulse wave techniques and plethysmography.

  7. Blood lipids and biomarkers in plasma. [ 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) and wash-out visit. ]
    Blood lipids and biomarkers in plasma.

  8. 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. These events are reported post-hoc by site to the sponsor.

  9. Frequency of foot ulcer and non-traumatic amputation. [ Time Frame: On study completion. ]
    Frequency of foot ulcer and non-traumatic amputation. These events are reported post-hoc by site to the sponsor.

  10. Macular volume. [ Time Frame: On study completion. ]
    Macular volume measured by Optical Coherence Tomography (OCT).

  11. 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.

  12. Occurrence of clinically significant macula oedema (CSME). [ 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) measured by optical coherence tomography and retinal photography.

  13. Need for laser surgery. [ 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). ]
    Need for laser surgery measured by progression of retinopathy per standard ophthalmological assessment.

  14. Need for intraocular anti-VEGF (vascular endothelial growth factor) injection. [ 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). ]
    Need for intraocular anti-VEGF (vascular endothelial growth factor) injection as per standard ophthalmological assessment.

  15. Need for corticosteroid therapy. [ 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). ]
    Need for corticosteroid therapy to treat progressive retinopathy as per standard ophthalmological assessments.

  16. Need for vitrectomy procedure. [ 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). ]
    Need for vitrectomy procedure as per standard ophthalmological assessment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320345


Contacts
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Contact: Liping Li +61 2 9562 5000 fame1eye@ctc.usyd.edu.au

Locations
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Australia, New South Wales
Royal Prince Alfred Hospital Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Stephania Noonan       Stephanie.Noonan@health.nsw.gov.au   
Principal Investigator: Stephen Twigg         
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Contact: Syvlia Mallo         
Principal Investigator: Avinash Suryawanshi         
Garvan Institute of Medical Research Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Renee Richens       r.richens@garvan.org.au   
Principal Investigator: Jerry Greenfield         
Retina Associates - South West Retina Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Tania Tsang       tania@retina.com.au   
Principal Investigator: Gerald Liew         
Hunter Diabetes Centre Recruiting
Merewether, New South Wales, Australia, 2291
Contact: Maureen Rae       maureen@hunterdiabetes.com.au   
Principal Investigator: Claire Morbey         
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Contact: Jean Doyle       Jean.doyle@health.nsw.gov.au   
Principal Investigator: Greg Fulcher         
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Deborah Gilroy       Deborah.Gilroy@health.qld.gov.au   
Principal Investigator: Anthony Russell         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Denise Healy         
Principal Investigator: Liza Phillips         
Southern Adelaide Diabetes and Endocrine Services Recruiting
Oaklands Park, South Australia, Australia, 5046
Contact: Fahriya Zandari       fahriya.zandari@sa.gov.au   
Principal Investigator: Stephen Stranks         
Australia, Victoria
Barwon Health Recruiting
Geelong, Victoria, Australia, 3220
Contact: Louise O'Callaghan       locallaghan@barwonhealth.org.au   
Principal Investigator: Mark Kotowicz         
Heidelberg Repatriation Hospital Recruiting
Heidelberg, Victoria, Australia, 3081
Contact: Mariam Hachem       mariam.hachem@unimelb.edu.au   
Principal Investigator: Elif Ekinci         
Baker Heart and Diabetes Institute Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Erin Boyle       erin.boyle@baker.edu.au   
Principal Investigator: Neale Cohen         
St Vincent's Hospital Melbourne Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Sue Kent       sue.kent@unimelb.edu.au   
Principal Investigator: David O'Neal         
Australia, Western Australia
Fremantly Hospital Recruiting
Fremantle, Western Australia, Australia, 6160
Contact: Michelle England       Michelle.england@uwa.edu.au   
Principal Investigator: Tim Davis         
New Zealand
Auckland Diabetes Centre Recruiting
Auckland, New Zealand, 1051
Contact: Tricha Ball       TrichaB@adhb.govt.nz   
Principal Investigator: Manish Khanolkar         
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Contact: Prasanna Karunasekera       Prasanna.Karunasekera@cdhb.health.nz   
Principal Investigator: Russell Scott         
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Juvenile Diabetes Research Foundation Australia
Mylan Pharmaceuticals
Investigators
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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
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT01320345    
Other Study ID Numbers: FAME0001
ACTRN12611000249954 ( Registry Identifier: Australian New Zealand Clinical Trials Registry (ANZCTR) )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: August 2019

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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
Keywords provided by University of Sydney:
Diabetes Mellitus
Type 1 Diabetes Mellitus
Retinopathy
Diabetic Nephropathy
Fenofibrate
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents