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    Summary
    EudraCT Number:2021-004015-11
    Sponsor's Protocol Code Number:MAD2021-07
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-07
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004015-11
    A.3Full title of the trial
    Investigator led, double-masked, multicenter, randomized clinical trial for the comparison of Atropine 0.5% versus Atropine 0.05% eye drops for the prevention of myopia progression in Dutch children.
    Een dubbelblinde, multicenter, gerandomiseerde klinische studie voor de vergelijking van Atropine 0.5% oogdruppels versus Atropine 0.05% ter preventie van myopie progressie bij Nederlandse kinderen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare Atropine eye drops of 0.05% versus Atropine 0.5% to avoid myopia progression in Dutch Childeren.
    Een klinische studie die Atropine oogdruppels van 0.05% vergelijkt met Atropine 0.5% om myopie progressie te voorkomen bij Nederlandse kinderen.
    A.3.2Name or abbreviated title of the trial where available
    Myopia Atropine Dose study (MAD)
    Myopie Atropine Dosis studie (MAD)
    A.4.1Sponsor's protocol code numberMAD2021-07
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointJan Roelof Polling
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Molewaterplein
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.polling@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 MINIMS ATROPINESULFAAT oogdruppels
    D.2.1.1.2Name of the Marketing Authorisation holderApotheek A15
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Eye drops
    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 INNATROPINE SULFATE
    D.3.9.1CAS number 55-48-1
    D.3.9.4EV Substance CodeSUB00625MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAtropine sulfate eye drops (opthalmic use).
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myopia
    Myopie
    E.1.1.1Medical condition in easily understood language
    Nearsightedness the ability to see close objects more clearly than distant objects. This is caused by an eyeball that is longer than normal and needs minus glasses to correct the image on the retina.
    Myopie (bijziendheid) is een afwijking van het oog waarbij een min-bril nodig is om scherp te zien in de verte. Dit komt doordat de oogbol te lang is.
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse.
    To create an online BIG DATA registry for myopia treatment in the Netherlands which can be used for evaluation of myopia progression in the long term.
    In de Myopia Atropine Dose Trial vergelijken wij 0,05% met 0,5% atropine in 550 kinderen met progressieve bijziendheid in een multi-center, dubbelblind gerandomiseerd onderzoek. De trial fase van het onderzoek duurt 3 jaar, en zal gevolgd worden door een observatie fase van 2 jaar. Toename van de oogaslengte, brilsterkte, de bijwerkingen en therapietrouw worden onderzocht. In de observatie fase wordt de aslengte groei na het stoppen van de trialmedicatie gevolgd. Onderzoeksgegevens worden in een nationaal online platform verzameld en vormen de basis voor verder onderzoek naar bijziendheid in Nederland. De uitkomsten van dit onderzoek zullen uitwijzen welke concentratie de preferente behandeling voor myopie beheersing in Nederland moet zijn, en aantonen of er subgroepen zijn die beter gedijen bij een bepaalde concentratie.
    E.2.2Secondary objectives of the trial
    Not applicable
    N.v.t.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children aged 6 to <11 years
    Onset of myopia >=4 years of age
    Spherical Equivalent Refraction (SER) of at least -1.50 D and no greater than -6.00 D in each eye
    Intraocular pressure <21 mm Hg in each eye
    Kinderen met de leeftijd van 6 tot 11 jaar
    Start myopie >=4 jarige leeftijd
    Sferische Equivalent Refractie (SER) van tenminste -1.50 dioptrie en niet meer dan -6.00 in ieder oog
    Intra-oculaire druk van lager dan 21 mm Hg in ieder oog
    E.4Principal exclusion criteria
    Allergy to Atropine or other excipients of the eye drops
    History of amblyopia or strabismus
    History of retinal dystrophy or systemic disorder that predisposes to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity).
    Abnormal ocular biometry aside from axial length (e.g., keratoconus, lenticonus, spherophakia) or previous intraocular or ocular laser/non-laser surgery
    History of glaucoma; anatomic narrow anterior chamber angles
    Prior myopia control treatment (Atropine, ortho-keratology, multifocal contact lenses).
    Allergie voor atropine
    Geschiedenis van amblyopie of scheelzien
    Geschiedenis van retinale dystrofie of systemische aandoening die vatbaar maakt voor ernstige bijziendheid (bijv. Marfan-syndroom, retinitis pigmentosa, Stickler-syndroom, prematuriteitsretinopathie).
    Abnormale oculaire biometrie afgezien van axiale lengte (bijv. keratoconus, lenticonus, sferofakie) of eerdere intraoculaire of oculaire laser-/niet-laserchirurgie
    Geschiedenis van glaucoom; anatomische smalle voorkamerhoeken
    Voorafgaande behandeling van myopiecontrole (atropine, orthokeratologie, multifocale contactlenzen)
    E.5 End points
    E.5.1Primary end point(s)
    Progression of AL in mm at Month 36 and Month 60.
    Progressie van axiale lengte in mm bij maand 36 en maand 60.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 36 and Month 60.
    Maand 36 en maand 60.
    E.5.2Secondary end point(s)
    Not applicable
    N.v.t.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    N.v.t.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned29
    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
    Last two years of the trial are observational.
    De laatste twee jaar van de studie zijn observationeel.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 550
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 550
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state550
    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)
    none
    geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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