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    Summary
    EudraCT Number:2016-002656-24
    Sponsor's Protocol Code Number:CTSULENS1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-23
    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 number2016-002656-24
    A.3Full title of the trial
    A randomised placebo-controlled clinical trial of fenofibrate to prevent progression of non-proliferative retinopathy in diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study testing whether the cholesterol-lowering medicine fenofibrate can slow down the progression of diabetic eye disease
    A.3.2Name or abbreviated title of the trial where available
    LENS version 1.0
    A.4.1Sponsor's protocol code numberCTSULENS1
    A.5.4Other Identifiers
    Name:NIHR project numberNumber:14/49/84
    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 SponsorUniversity of Oxford (Clinical Trials and Research Governance))
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Service Unit and Epidemiology Unit
    B.5.2Functional name of contact pointSarah Howard
    B.5.3 Address:
    B.5.3.1Street AddressRichard Doll Building, Oldr Road Campus, Roosevelt Drive,
    B.5.3.2Town/ cityHeadington, Oxford
    B.5.3.3Post codeOX3 7LF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865743825
    B.5.5Fax number01865743986
    B.5.6E-maillens@ndph.ox.ac.uk
    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 Yes
    D.2.1.1.1Trade name Lipantil Supra 145mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMylan IRE Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameLipantil Supra 145mg film-coated tablets
    D.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 49562-28-9
    D.3.9.2Current sponsor codefenofibrate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number145
    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 placeboFilm-coated tablet
    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
    Diabetic retinopathy and diabetic maculopathy
    E.1.1.1Medical condition in easily understood language
    Diabetic eye disease
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10012689
    E.1.2Term Diabetic retinopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025425
    E.1.2Term Maculopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the LENS trial is to investigate whether treatment with fenofibrate can slow down the progression of diabetic retinopathy to a clinically significant level compared to treatment with placebo.
    E.2.2Secondary objectives of the trial
    We will also investigate whether treatment with fenofibrate versus placebo has an effect upon:
    (i) progression to clinically significant retinopathy in specific groups of patients (e.g. men vs. women)
    (ii) the need for specialist treatment of retinopathy; this may include retinal laser treatment, surgery (a procedure called a vitrectomy to remove the jelly-like substance found in the eye), or a course of injections of medicine into the eye
    (iii) visual acuity (this is the quality of one's vision)
    (iv) questionnaires about one's quality of life
    (v) In addition, we will also assess whether using fenofibrate to treat patients with retinopathy is cost-effective for the NHS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i) Subjects capable of giving informed consent
    ii) Diabetes Mellitus (any type except gestational diabetes)
    iii) Age 18 years or above
    iv) Observable diabetic retinopathy (defined in the Scottish national retinopathy grading scheme as R2 and/or M1 in one/both eyes, or R1 in both eyes) at the patient's most recent retinal screening visit
    v) Willing to either complete electronic questionnaires or conduct telephone interviews for collection of questionnaire data once every 6 months
    E.4Principal exclusion criteria
    i) Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
    ii) History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
    iii) History of acute or chronic pancreatitis
    iv) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2X the upper limit of normal (ULN) according to local NHS laboratory reference range
    v) Creatine kinase (CK) >3X ULN according to local NHS laboratory reference range
    vi) Estimated glomerular filtration rate (eGFR) <40mL/min/m2 at screening
    vii) Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)
    viii) Female who is pregnant, breastfeeding, currently trying to become pregnant, or of child-bearing potential and not practicing birth control
    ix) Ongoing warfarin, cyclosporine, vitamin K antagonist (warfarin, phenindione, acenocoumarol), colchicine, ketoprofen, daptomycin or fibrate therapy
    x) Previous myositis or rhabdomyolysis of any cause, or diagnosed hereditary muscle disorder
    xi) Ongoing renal replacement therapy
    xii) Any previous organ transplant
    xiii) Previous reported intolerance to any fibrate
    xiv) Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer within last 5 years other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
    xv) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
    E.5 End points
    E.5.1Primary end point(s)
    The composite primary outcome is the development of clinically significant diabetic retinopathy (as defined in the retinal screening program) or any of the following treatments for retinopathy: retinal laser therapy, vitrectomy or intra-vitreal injection.

    LENS will investigate the effect of allocation to fenofibrate versus placebo on progression to this composite primary outcome.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LENS is a heavily streamlined trial which will collect outcome data from routinely collected health information (using linkage to registers) and from questionnaires, so there is no fixed timepoint for evaluation of this endpoint. However, it should be noted that retinal screening is offered every 6-12 months for patients with observale retinopathy in Scotland. And questionnaires will be conducted every 6-12 months.
    E.5.2Secondary end point(s)
    1. The individual components of the composite primary outcome, i.e.:
    (i) Progression of to clinically significant retinopathy
    (ii) Retinal laser therapy for retinopathy
    (iii) Vitrectomy for retinopathy
    (iv) Intra-vitreal injection for retinopathy
    2. Composite of retinal laser, vitrectomy or intra-vitreal injection for retinopathy
    3. Any progression of retinopathy across Scotland's national retinopathy grading scale
    4. Visual acuity (according to LogMAR or Snellen chart measurement conducted at retinal screening visits)
    5. The development of hard exudates within 1 disc diameter of the macula
    6. Visual function (according to the Visual Function Questionnaire [VFQ]-25 questionnaire, conducted once every 12 months)
    7. Quality of life (according to the EQ-5D questionnaire, conducted once every 12 months)
    8. Total cost to the health service (in terms of additional drug treatment and monitoring costs, and health care resource
    use over follow-up)
    E.5.2.1Timepoint(s) of evaluation of this end point
    LENS is a heavily streamlined trial which will collect outcome data from routinely collected health information (using linkage to registers) and from questionnaires, so there is no fixed timepoint for evaluation of most of these endpoints. However, it should be noted that retinal screening is offered every 6-12 months for patients with observale retinopathy in Scotland. And questionnaires will be conducted every 6-12 months.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    It is intended for the trial to continue until 222 primary events have occurred or until median follow up is at least 4 years, whichever is the later.

    The ‘end of study’ is defined as the date on which the trial database is locked.

    Given the streamlined nature of the trial where we are heavily reliant on receiving linkage data from various NHS sources, delays in receiving the data for the final linkage have been considered when deciding on this definition.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 460
    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 state1060
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1060
    F.4.2.2In the whole clinical trial 1060
    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)
    At the end of the trial, all study treatment will be discontinued; this is explained in the Detailed Patient Information Leaflet. Participants will continue with their routine medical care.

    A positive result in LENS will enable fenofibrate to be considered for addition to national and international diabetes guidelines for the treatment of diabetic retinopathy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AndersonBrecon
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-27
    P. End of Trial
    P.End of Trial StatusOngoing
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