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    Summary
    EudraCT Number:2018-003180-54
    Sponsor's Protocol Code Number:20275
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-04-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003180-54
    A.3Full title of the trial
    An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090
    Studio di estensione volto alla valutazione degli esiti a lungo termine dei soggetti sottoposti a trattamento per la retinopatia del prematuro nell’ambito dello Studio 20090
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study to evaluate the long-term outcomes of subjects in study 20090
    Studio di estensione per la valutazione degli esiti a lungo termine dei soggetti dello Studio 20090
    A.3.2Name or abbreviated title of the trial where available
    FIREFLeYe Next
    FIREFLeYe Next
    A.4.1Sponsor's protocol code number20275
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/115/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref: 'EU CTR' /Bayer AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    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 No therapeutic treatment is administered in the context of this investigation, however subjects have previously received Aflibercept 40mg/ml in the context of study 20090.
    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 nameAflibercept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAflibercept
    D.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeBAY 86-5321
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Retinopathy of prematurity
    retinopatia del prematuro (ROP)
    E.1.1.1Medical condition in easily understood language
    Retinopathy of prematurity
    Malattie dell’occhio
    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 10038933
    E.1.2Term Retinopathy of prematurity
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate long-term safety outcomes and visual function of subjects included in study 20090 for treatment for retinopathy of prematurity (ROP)
    Valutare gli esiti in termini di sicurezza e la funzione visiva a lungo termine dei partecipanti allo studio 20090 per il trattamento della retinopatia del prematuro (ROP)
    E.2.2Secondary objectives of the trial
    To describe the visual function and overall development of subjects included in study 20090 for treatment for ROP
    Descrivere la funzione visiva e lo sviluppo generale dei soggetti dello studio 20090 per il trattamento della ROP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible to be included in the study only if both of the following criteria apply:
    1.Subject was treated in Study 20090
    2.Age less than 13 months of chronological age
    3.Signed informed consent from parent(s)/legally authorized representative(s) as described in Section 10.1.3 of the clinical trial protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
    Subjects are eligible to be included in the study only if both of the
    following criteria apply:
    1.Subject was treated in Study 20090
    2.Age less than 13 months of chronological age
    3.Signed informed consent from parent(s)/legally authorized
    representative(s) as described in Section 10.1.3 of the clinical trial
    protocol, which includes compliance with the requirements and
    restrictions listed in the informed consent form (ICF) and in the protocol
    E.4Principal exclusion criteria
    Subjects are excluded from the study if the following criterion applies:
    Medical Conditions
    1. Subject has a condition preventing participation in the study, or performance of study procedures

    Subjects are excluded from the study if the following criterion applies:
    Medical Conditions
    1. Subject has a condition preventing participation in the study, or
    performance of study procedures
    E.5 End points
    E.5.1Primary end point(s)
    • Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age
    Acuità visiva con la migliore correzione binoculare con il punteggio equivalente sulla tabella di Snellen a 5 anni di età
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 5 years of age
    a 5 anni di età
    E.5.2Secondary end point(s)
    Secondary endpoints addressing primary objective:
    •Proportion of subjects with ocular adverse events (AEs) and serious AEs (SAEs) through 5 years of age
    •Proportion of subjects with systemic AEs and SAEs through 5 years of age

    Secondary endpoints addressing secondary objectives:
    •Proportion of subjects developing unfavorable ocular structural outcome (retinal detachment, macular dragging, macular fold, retrolental opacity) at 1, 3, and 5 years of age
    •Proportion of subjects with absence of active ROP and unfavorable structural outcomes at 1 year of age
    •Best-corrected visual acuity in each eye at 3 and 5 years of age
    •Refractive spherical equivalent in each eye at 3 and 5 years of age
    •Neurodevelopmental outcomes at 2 and 5 years of age using standardized development tests (eg, Bayley-III, DAS-II, WPPSI-IV)
    •Proportion of subjects with recurrence of ROP at 3 and 5 years of age
    •Proportion of subjects requiring treatment for ROP during this extension study
    •Proportion of subjects requiring ophthalmological treatment during this extension study
    Endpoint secondari associati all'obiettivo primario:

    Percentuale di soggetti con eventi avversi (EA) ed EA gravi (SAE) a carico degli occhi fino ai 5 anni di età
    Percentuale di soggetti con EA e SAE sistemici fino ai 5 anni di età

    Endpoint secondari associati agli obiettivi secondari:

    • Percentuale di soggetti che sviluppano esiti strutturali oculari sfavorevoli (distacco della retina, dragging maculare, piega maculare, opacità retrolentale) a 1, 3 e 5 anni di età
    • Percentuale di soggetti senza ROP attiva ed esiti strutturali sfavorevoli a 1 anno di età
    • Acuità visiva con la migliore correzione di ciascun occhio a 3 e 5 anni di età
    • Equivalente sferico refrattivo di ciascun occhio a 3 e 5 anni di età
    • Esiti nello sviluppo neurologico a 2 e 5 anni di età utilizzando test standardizzati dello sviluppo (ad esempio Bayley Scales of Infant and Toddler Development, Third Edition [Bayley-III], Differential Ability Scales® II [DAS-II®], Wechsler Preschool and Primary Scale of Intelligence™, Fourth Edition [WPSSI-IV]).
    • Percentuale di soggetti con recidiva della ROP a 3 e 5 anni di età
    • Percentuale di soggetti che necessitano di un trattamento per la ROP durante questo studio di estensione
    E.5.2.1Timepoint(s) of evaluation of this end point
    through 5 years of age
    nei primi 5 anni di età
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Visual function of subjects included in study 20090 for treatment for retinopathy of prematurity (ROP)
    Funzione visive di Pazienti inclusi nello studio 20090 per il trattamento della retinopatia da prematuro (ROP)
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Argentina
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Democratic People's Republic of
    Latvia
    Lithuania
    Malaysia
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Singapore
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    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
    The end of the study as a whole is defined as the date of the last visit of the last subject in the study in all centers in all participating countries (EU and non-EU).
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 102
    F.1.1.1In Utero No
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 102
    F.1.1.5Children (2-11years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Babies with approximately 6-7 months when entering the trial
    bambini che abbiano 6-7 mesi di età all’entrata in studio
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 102
    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
    na
    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 Decision2019-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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