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    Summary
    EudraCT Number:2016-001460-11
    Sponsor's Protocol Code Number:15/0599
    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:2016-05-19
    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 number2016-001460-11
    A.3Full title of the trial
    Corneal cross-linking versus standard care in children with keratoconus, a randomised, multicentre, observer-masked trial of efficacy and safety
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of cross-linking in children with Keratoconus
    A.3.2Name or abbreviated title of the trial where available
    KERALINK
    A.4.1Sponsor's protocol code number15/0599
    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 SponsorUCL CCTU
    B.1.3.4Country
    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, EME Program
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCL CCTU
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressGower Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1E 6BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)20 3108 3942
    B.5.6E-mailv.mccudden@ucl.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 No
    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 nameRiboflavin
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRiboflavin Phosphat
    D.3.9.3Other descriptive nameVitamin B2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with progressive keratoconus disease
    E.1.1.1Medical condition in easily understood language
    Keratoconus affects the young, presenting in adolescence with impaired vision. This distortion of vision is due to the forward bowing of the weakened cornea.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10023353
    E.1.2Term Keratoconus
    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 primary objective of the clinical trial is to establish whether cross-linking is efficacious in stabilising the progression of keratoconus, and whether it is safe in patients under 17 years. The main outcome measure will be the change in Kmax overall in the 2 groups in the time from randomisation and completion of 18 months follow-up. Kmax is an indicator derived from corneal topography and changes in this measure indicate whether keratoconus is progressing or not. Safety of CXL will also be monitored carefully at all follow up time points.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to measure the effect of CXL on keratoconus progression from baseline to 18 months in both arms of the trial, including the requirement for change from spectacle to rigid contact lens correction of vision. We will measure keratoconus progression (defined as more than 1.5 dioptres Kmax increase from randomisation) in individual patients, visual acuity with and without glasses or contact lenses, refraction (the measurement for glasses or contact lenses), central corneal thickness, patient-reported visual function and quality of life. Secondary safety outcomes in CXL-treated corneas include corneal opacification, infection and endothelial cell density.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children and young patients aged 10-16 years with keratoconus progression confirmed in one or both eyes by Pentacam corneal topography. Progression will be defined as an increase of at least 1.5D in Kmax on corneal topography between two Pentacam examinations at least three months apart.
    - Patients must be sufficiently fluent in English to provide informed consent and completion of the patient reported outcome measures.
    - Patients must be willing to attend for follow-up visits.
    E.4Principal exclusion criteria
    - Advanced keratoconus as determined by apex corneal scarring.
    - Apex corneal thickness <400μ.
    - Maximum corneal curvature (Kmax) >60 diopres.
    - Rigid contact lens wear in both eyes and unable to abstain for 7days pre-examinations.
    - Corneal co-morbidity.
    - Down's syndrome.
    - Any clinical condition which the investigator considers would make the patient unsuitable for the trial, including pregnancy.
    - Participation in other clinical trials which would materially impact on the Keralink study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measure is Kmax in the study eye at 18 months post randomisation
    NB. The study eye is defined as the eye with the more advanced keratoconus at randomisation. The same intervention will be offered for the second eye for patients with progression in both eyes, unless the patient does not wish to receive the same intervention. Information from the second treated eye will be included in secondary analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint for evaluation will be the 18 month follow-up visit post randomisation, however, for participants with progression at the 18 month visit a second timepoint at 21 month will be used to confirm this progression.
    E.5.2Secondary end point(s)
    a) Keratoconus progression (yes/no) defined as >1.5 dioptre increase in Kmax* from baseline (at randomisation) to 18 months or requirement for change from spectacle to rigid contact lenses correction of vision, as the latter precludes reliable topography measures
    b) Time to Keratoconus progression
    c) Uncorrected and best corrected visual acuity (measured as logMAR)
    d) Refraction (measured dioptres spherical equivalent, myopia and astigmatism)
    e) Central corneal thickness (ultrasound)
    f) Quality of life as assessed by CHU9D and VF-14 questionnaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoint for evaluation will be the 18 month follow-up visit post randomisation, however, for participants with progression at the 18 month visit a second timepoint at 21 month will be used to confirm this progression.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard treatment with glasses and / or contact lenses
    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 concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    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 state60
    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)
    All participating hospitals are providing CXL treatment to NHS patients on a routine basis, in both adults and children. Both CXL treatment and the standard care are already available in all sites and will continue to be available when the study has finished.
    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 North Thames Clinical Research Network
    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 Decision2016-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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