A Trial in Adults With Type 1 Diabetes Mellitus Evaluating the Effects of Fenofibrate Versus Placebo on Macular Thickness and Volume (FAME 1 EYE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2011 by University of Sydney
Sponsor:
Collaborators:
Abbott
University of Melbourne
St Vincent's Hospital Melbourne
Melbourne Health
Royal Prince Alfred Hospital, Sydney, Australia
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT01320345
First received: March 18, 2011
Last updated: January 15, 2012
Last verified: March 2011
  Purpose

The purpose of this study is to evaluate the potential benefits of Fenofibrate in 300 adults with Type 1 diabetes mellitus who are at high risk of eye damage.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Retinopathy
Diabetic Nephropathy
Drug: Fenofibrate
Drug: Inert lactose placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Fenofibrate And Microvascular Event Eye (FAME 1 EYE) Trial: A Randomised Trial in Adults With Type 1 Diabetes Mellitus Evaluating the Effects of Daily Oral Fenofibrate Compared With Placebo on Macular Thickness and Volume

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Central zone macular thickness measured using optical coherence tomography [ Time Frame: At 12 months after randomisation ] [ Designated as safety issue: No ]
  • Total macular volume measured using optical coherence tomography. [ Time Frame: At 12 months after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Albuminuria measured as urinary albumin:creatinine ratio. [ Time Frame: Assessed at 12 months after randomisation ] [ Designated as safety issue: No ]
  • Visual acuity using Snellen Chart [ Time Frame: At 12 months after randomisation ] [ Designated as safety issue: No ]
  • Corneal confocal microscopic measurement of neural damage (only assessed in a representative subset of the participants at sites with the specialised confocal microscope). [ Time Frame: At 12 months after randomisation ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate using MDRD formula [ Time Frame: At 12 months after randomisation. ] [ Designated as safety issue: No ]
  • Peripheral neuropathy status assessed by temperature sensation and monofilament sensation. [ Time Frame: At 12 months after randomisation. ] [ Designated as safety issue: No ]
  • Vascular function using non-invasive pulse wave techniques and plethysmography. [ Time Frame: At 12 months after randomisation. ] [ Designated as safety issue: No ]
  • Blood lipids and biomarkers in plasma [ Time Frame: At 6 weeks, 6 months and 12 months after randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenofibrate Drug: Fenofibrate
Oral Fenofibrate 145mg given once daily for 12 months.
Placebo Comparator: Placebo Drug: Inert lactose placebo
Oral matching inert lactose placebo given once daily for 12 months.

Detailed Description:

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 oral Fenofibrate 145mg once daily for 12 months in 300 adults with Type 1 diabetes mellitus who are at high risk of eye damage.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 1 diabetes mellitus
  • Over 18 years of age
  • Established macular thickening on optical coherence tomography (OCT) greater than or equal to 300 micrometres in at least one macular zone
  • No definite indication for receiving, and no contraindication to receiving fenofibrate in addition to their existing therapy

Exclusion Criteria:

  • Subjects with type 1 diabetes mellitus and the contraindications of definite need for intra-ocular treatment or photocoagulation therapy within next 3 months
  • Allergy to any fibrate drugs
  • History of pancreatitis or pulmonary embolism or DVT
  • Use of any other investigational agents in last 8 weeks
  • Unstable condition including recent MI, heart failure, prior organ transplant, severe renal or liver dysfunction, history of myositis or untreated hypothyroidism
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320345

Contacts
Contact: Anthony Keech, Professor +61 2 95625003 tony@ctc.usyd.edu.au
Contact: Alicia Jenkins, Professor +1 4052504069 alicia-jenkins@ouhsc.edu

Locations
United States, Oklahoma
Oklahoma University Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Alicia Jenkins, Professor       alicia-jenkins@ouhsc.edu   
Principal Investigator: Alicia Jenkins, Professor         
Principal Investigator: Timothy Lyons, Dr         
Australia, New South Wales
NHMRC Clinical Trials Centre Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Anthony Keech, Professor       tony@ctc.usyd.edu.au   
Principal Investigator: Anthony Keech, Professor         
Royal Prince Alfred Hospital Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Stephen Twigg, Professor       stephen.twigg@sydney.edu.au   
Principal Investigator: Stephen Twigg, Professor         
Westmead Children's Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Kim Donaghue, Professor       kimd@chw.edu.au   
Principal Investigator: Kim Donaghue, Professor         
Australia, Victoria
St Vincents Hospital
Melbourne, Victoria, Australia, 3065
Royal Melbourne Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3050
Contact: Peter Colman, Professor       peter.colman@mh.org.au   
Principal Investigator: Peter Colman, Professor         
Sponsors and Collaborators
University of Sydney
Abbott
University of Melbourne
St Vincent's Hospital Melbourne
Melbourne Health
Royal Prince Alfred Hospital, Sydney, Australia
Investigators
Principal Investigator: Anthony Keech, Professor University of Sydney, NHMRC Clinical Trials Centre
  More Information

No publications provided

Responsible Party: Professor Anthony Keech, University of Sydney, NHMRC Clinical Trials Centre
ClinicalTrials.gov Identifier: NCT01320345     History of Changes
Other Study ID Numbers: FAME0001, ACTRN12611000249954
Study First Received: March 18, 2011
Last Updated: January 15, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
Diabetes Mellitus
Type 1 Diabetes Mellitus
Retinopathy
Diabetic Nephropathy
Fenofibrate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Kidney Diseases
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications
Eye Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014