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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.
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
History of Changes

March 18, 2011
January 15, 2012
September 2011
September 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01320345 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial in Adults With Type 1 Diabetes Mellitus Evaluating the Effects of Fenofibrate Versus Placebo on Macular Thickness and Volume
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 1 Diabetes Mellitus
  • Retinopathy
  • Diabetic Nephropathy
  • Drug: Fenofibrate
    Oral Fenofibrate 145mg given once daily for 12 months.
  • Drug: Inert lactose placebo
    Oral matching inert lactose placebo given once daily for 12 months.
  • Experimental: Fenofibrate
    Intervention: Drug: Fenofibrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Inert lactose placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Anthony Keech, Professor +61 2 95625003 tony@ctc.usyd.edu.au
Contact: Alicia Jenkins, Professor +1 4052504069 alicia-jenkins@ouhsc.edu
United States,   Australia
 
NCT01320345
FAME0001, ACTRN12611000249954
No
Professor Anthony Keech, University of Sydney, NHMRC Clinical Trials Centre
University of Sydney
  • Abbott
  • University of Melbourne
  • St Vincent's Hospital Melbourne
  • Melbourne Health
  • Royal Prince Alfred Hospital, Sydney, Australia
Principal Investigator: Anthony Keech, Professor University of Sydney, NHMRC Clinical Trials Centre
University of Sydney
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP