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    Summary
    EudraCT Number:2019-002591-14
    Sponsor's Protocol Code Number:CTC0128
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-09-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-002591-14
    A.3Full title of the trial
    The Fenofibrate And Microvascular Events in Type 1 diabetes Eye (FAME 1 Eye):
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FAME 1 Eye trial
    A.3.2Name or abbreviated title of the trial where available
    FAME 1 Eye
    A.4.1Sponsor's protocol code numberCTC0128
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01320345
    A.5.4Other Identifiers
    Name:Australian New Zealand Clinical Trial Registry Number:ACTRN12611000249954
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBelfast Health & Social Care Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNHMRC Clinical Trials Centre
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBelfast Health & Social Care Trust
    B.5.2Functional name of contact pointAlison Murphy, Research Manager
    B.5.3 Address:
    B.5.3.1Street AddressResearch Office, 2nd Floor King Edward Building, Royal Hospital, Grosvenor Road
    B.5.3.2Town/ cityBelfast
    B.5.3.3Post codeBT12 6BA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02890636366
    B.5.6E-mailalison.murphy@belfasttrust.hscni.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFenofibrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFenofibrate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To evaluate the effects of once daily oral fenofibrate compared with placebo on clinically meaningful retinopathy progression over at least 3 years in adults with Type 1 diabetes (T1D) and existing diabetic retinopathy
    E.1.1.1Medical condition in easily understood language
    Adult Type 1 diabetes with diabetic eye disease
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10012608
    E.1.2Term Diabetes mellitus insulin-dependent
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine that in 450 adults with T1D and diabetic eye disease, 3 years of treatment with once daily fenofibrate compared with placebo treatment will protect against clinically significant diabetic eye disease progression and deterioration of other measures of ocular health, macular oedema, need for laser surgery, need for intra-ocular VEGF or corticosteroid therapy, or vitrectomy for diabetic retinopathy.
    E.2.2Secondary objectives of the trial
    To determine that once daily fenofibrate compared with placebo treatment will also:
    - benefit other clinical small vessel complications, including renal function, small artery elasticity, vascular resistance and nerve function, and prevent cardiovascular events
    - favourably affect vascular risk biomarkers in relate to vascular complications in T1D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants meeting all of the following criteria will be considered for enrolment into the 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-GAD, anti-A2, anti-ZnT8).
    2) Age 18 years or over;
    3) 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 study.
    E.4Principal 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 onto 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 3xULN;
    11) Persistent elevated unexplained blood CPK level above normal range;
    12) Documented fasting TG levels >6.5 mmol/L;
    13) History of pancreatitis, 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) 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 cell) with subsequent continued immunosuppression therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The occurrence of clinically significant retinopathy progression – defined as comprising 2-step progression of ETDRS score (to at least moderately severe grade) as assessed by masked adjudication, occurrence of clinically significant macular oedema (CSME – assessment of [masked] ophthalmologist), need for laser surgery, need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy adjudicated to be for retinopathy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2-step progression of ETDRS score will be assessed based on annual retinal photography;
    Occurrence of clinically significant macular oedema will be assessed based on annual OCT and/or events reported on the outcome form during the 3-6 monthly follow up visits;
    Need for laser surgery, or intraocular anti-VEGF or corticosteroid therapy or vitrectomy will be reported on the outcome form during the 3-6 monthly follow up visits.
    E.5.2Secondary end point(s)
    1) The individual components of the primary endpoint;
    2) Visual Acuity (VA);
    3) Retinal vessel calibre and geometry;
    4) Macular volume and thickness by Optical Coherence Tomography (OCT);
    5) Urine albumin:creatinine ratio [ACR];
    6) eGFR (measured 8 weeks after treatment withdrawal);
    7) Measures of peripheral neuropathy (symptoms, monofilament testing, vibration and temperature sensation;
    8) Autonomic neuropathy: QTc and RR intervals on yearly ECGs;
    9) Total cardiovascular events, including myocardial infarction (including silent MI by ECGs), stroke, sudden cardiac death, hospitalisation for acute coronary syndrome or any revascularization requirement;
    10) Frequency of foot ulcer and non-traumatic amputation;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same as primary end points for the individual components of the primary endpoint. Others end points either to be assessed on annual follow up assessments or to be reported on the CRF during the 3-6 monthly follow up visits.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Hong Kong
    New Zealand
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 450
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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