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:
University of Sydney
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
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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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Fenofibrate
U.S. FDA Resources
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
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 May 22, 2013