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Trial registered on ANZCTR


Registration number
ACTRN12618000592246
Ethics application status
Approved
Date submitted
23/03/2018
Date registered
17/04/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Multi-centre Placebo Controlled Trial of Fenofibrate for Treatment of Diabetic Macular Oedema with Economic Evaluation (FORTE Study)
Scientific title
A Randomised Multi-centre Placebo Controlled Trial of Fenofibrate for Treatment of Diabetic Macular Oedema with Economic Evaluation
Secondary ID [1] 290541 0
None
Universal Trial Number (UTN)
Trial acronym
FORTE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 300976 0
Condition category
Condition code
Eye 301443 301443 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 301446 301446 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will be asked to take one tablet of 145mg fenofibrate, once daily for 2 years. Adherence to the study drug will be monitored by drug tablet return, where the study coordinator will count the number of tablets in the bottle at the mandated study visits. Participants will be reviewed at pre-specified intervals within the 2 years of the study, and anti-VEGF (ranibizumab 0.5mg or aflibercept 2mg) or laser treatment administered in participants with clinical diabetic macular oedema (DME), according to an established protocol. Anti-VEGF injections or laser treatment are the 'standard care' for patients with clinical DME. 'Standard care' for pre-clinical DME is observation. Pre-clinical DME will be observed and only be treated if it progresses to clinical DME.
Intervention code [1] 296943 0
Treatment: Drugs
Comparator / control treatment
Participants in the control arm will take one placebo tablet (containing microcrystalline cellulose, colloidal silicone dioxide, sodium starch glycolate, sodium stearyl fumarate), once daily for 2 years. Participants will be reviewed at prespecified intervals within these 2 years, and anti-VEGF (ranibizumab 0.5mg or aflibercept 2mg) or laser treatment administered in participants with clinical DME according to an established protocol. Pre-clinical DME will only be treated if it progresses to clinical DME.
Control group
Placebo

Outcomes
Primary outcome [1] 300836 0
Reduction in macular oedema, measured objectively as a decrease in central macular thickness (CMT) on Spectral Domain-Optical Coherence Tomography (SD-OCT). CMT in participants on fenofibrate will be compared to the CMT of participants on placebo.
Timepoint [1] 300836 0
24 months from baseline
Secondary outcome [1] 331022 0
Number of intravitreal anti-VEGF injections or number of laser sessions needed for DME in each randomisation arm. If patients have received an anti-VEGF injection or laser therapy at a particular visit, it is entered into the patient clinic file on that day. The number of injections or laser sessions will also be recorded at each of the mandated visits on clinical research forms (CRFs).
Timepoint [1] 331022 0
24 months from baseline
Secondary outcome [2] 331026 0
Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity letter score gains.
Timepoint [2] 331026 0
24 months from baseline
Secondary outcome [3] 331035 0
Cost effectiveness of treatment of oral fenofibrate plus standard treatment versus standard treatment alone, assessed through linked MBS and PBS data.
Timepoint [3] 331035 0
24 months from baseline

Eligibility
Key inclusion criteria
1. Male or Female patients >= 25 years at the time of consent.
2. Diagnosed with type 2 diabetes
3. Diagnosed with DME on SD-OCT.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current use of fenofibrate
2. Pregnancy, or intention to become pregnant within the trial period
3. Contraindication to fenofibrate use.
4. Other causes of macular oedema including epiretinal membrane, vitreomacular traction, retinal vein occlusion, AMD, cataract surgery in the last 6 months.
5. Previous treatment for DME in the prior 12 months including focal/grid laser, anti-VEGF injections, intravitreal triamcinolone injections.
6. Active retinal neovascularisation requiring pan retinal photocoagulation laser therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/04/2018
Actual
12/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
392
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295410 0
Government body
Name [1] 295410 0
National Health and Medical Research Council
Country [1] 295410 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 297958 0
None
Name [1] 297958 0
n/a
Address [1] 297958 0
n/a
Country [1] 297958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296743 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296743 0
Ethics committee country [1] 296743 0
Australia
Date submitted for ethics approval [1] 296743 0
Approval date [1] 296743 0
08/01/2018
Ethics approval number [1] 296743 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70474 0
A/Prof Gerald Liew
Address 70474 0
Centre for Vision Research,
The Westmead Institute for Medical Research,
176 Hawkesbury Road
Westmead NSW 2145
Country 70474 0
Australia
Phone 70474 0
+61 2 8627 3367
Fax 70474 0
+61 2 8627 3099
Email 70474 0
gerald.liew@sydney.edu.au
Contact person for public queries
Name 70475 0
Gerald Liew
Address 70475 0
Centre for Vision Research,
The Westmead Institute for Medical Research,
176 Hawkesbury Road
Westmead NSW 2145
Country 70475 0
Australia
Phone 70475 0
+61 2 8627 3367
Fax 70475 0
+61 2 8627 3099
Email 70475 0
gerald.liew@sydney.edu.au
Contact person for scientific queries
Name 70476 0
Gerald Liew
Address 70476 0
Centre for Vision Research,
The Westmead Institute for Medical Research,
176 Hawkesbury Road
Westmead NSW 2145
Country 70476 0
Australia
Phone 70476 0
+61 2 8627 3367
Fax 70476 0
+61 2 8627 3099
Email 70476 0
gerald.liew@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.