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    Summary
    EudraCT Number:2014-005263-33
    Sponsor's Protocol Code Number:AUG-201202-EyNeP
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-26
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2014-005263-33
    A.3Full title of the trial
    Intravitreal Aflibercept (Eylea®) for therapy of choroidal
    neovascularization and fibrovascular proliferation in patients with Pseudoxanthoma elasticum
    Intravitreales Aflibercept (Eylea®) zur Therapie von choroidalen
    Neovaskularisationen und fibrovaskulären Proliferationen in Patienten mit Pseudoxanthoma elasticum
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravitreal Aflibercept (Eylea®) for therapy of choroidal
    neovascularization and fibrovascular proliferation in patients with Pseudoxanthoma elasticum
    Intravitreales Aflibercept (Eylea®) zur Therapie von choroidalen
    Neovaskularisationen und fibrovaskulären Proliferationen in Patienten mit Pseudoxanthoma elasticum
    A.3.2Name or abbreviated title of the trial where available
    EyNeP
    EyNeP
    A.4.1Sponsor's protocol code numberAUG-201202-EyNeP
    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 SponsorMedizinische Fakultät der Universität Bonn
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStudienzentrale SZB
    B.5.2Functional name of contact pointDr. med. Christoph Coch
    B.5.3 Address:
    B.5.3.1Street AddressSigmund-Freud-Straße 25
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53127
    B.5.3.4CountryGermany
    B.5.4Telephone number004922828716040
    B.5.5Fax number004922828716039
    B.5.6E-mailccoch@uni-bonn.de
    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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    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) Yes
    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
    Choroidal neovascularizations and fibrovascular proliferations in patients with Pseudoxanthoma elasticum
    Choroidale Neovaskularisationen und fibrovaskuläre Proliferationen bei Patienten mit Pseudoxanthoma elasticum
    E.1.1.1Medical condition in easily understood language
    Neubildung und Einwachsen von Blutgefäßen in die Netzhaut bei Patienten mit Pseudoxanthoma elasticum
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037150
    E.1.2Term Pseudoxanthoma elasticum
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Die Studie soll die Wirkung von Aflibercept bei choroidaler Neovaskularisation und fibrovaskulärer Proliferation in Bezug auf die Erhaltung oder Verbesserung der Sehschärfe evaluieren.
    E.2.2Secondary objectives of the trial
    - Untersuchung von Veränderung der retinalen Morphologie mittels bildgebender Verfahren (SD-OCT, cSLO, Fluoreszein-Angiographie)
    - Untersuchung der retinalen Funktion und der Fixation mittels funduskontrollierter Mikroperimetrie
    - Nachweis der Sicherheit des Prüfpräparates
    - Untersuchung der Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnose von PXE durch molekulargenetische Diagnostik und/oder Hautbiopsie
    • Diagnose einer CNV oder FVP bei Patienten mit PXE
    • Alter 18 - 65 Jahre
    • Schriftliche Einwilligung zur Teilnahme an der Studie.
    • Fähigkeit und Bereitschaft, die Studienanweisungen zu befolgen und alle erforderlichen Studienvisiten einzuhalten (Compliance)
    • Bester korrigierter Visus zwischen 20/400 bis 20/20 im Behandlungsauge
    • Korrekte Anwendung einer sicheren Verhütungsmethode bei gebärfähigen Patientinnen vor und während der Studienteilnahme (Pearl Index <1) oder Postmenopause seit 2 Jahren oder Zustand nach Gebärmutterentfernung
    • negativer Schwangerschaftstest (Blut)
    E.4Principal exclusion criteria
    Generelle Ausschlusskriterien:
    • Unfähigkeit, die Bedeutung und die Konsequenzen dieser klinischen Prüfung zu verstehen
    • Bekannte Allergie gegen das Prüfpräparat oder gegen Präparate mit ähnlicher chemischer Struktur
    • Gleichzeitige Teilnahme an einer anderen klinischen Prüfung oder Teilnahme an einer klinischen Prüfung mit Einnahme eines Prüfpräparats bis zu 30 Tage vor Teilnahme an dieser klinischen Prüfung
    • Bekannter Missbrauch von Medikamenten, Drogen oder Alkohol
    • Vorliegende oder geplante Schwangerschaft oder Stillzeit
    • Fehlende Eignung des Patienten zur Studienteilnahme nach Maßgabe des Untersuchers
    Indikationsspezifische Ausschlusskriterien:
    • Okuläre operative Eingriffe innerhalb eines Monats vor Studieneinschluss
    • Anamnese eines nicht kontrollierten Glaukoms
    • Aktive intraokuläre Entzündung oder Entzündung der okulären Adnexe
    • Sonstige Erkrankungen, die mit einer ausgeprägten visuellen Einschränkung einhergehen
    • Ausgeprägte Trübung der optischen Medien
    • Ausgeprägte subretinale Fibrose und/oder Atrophie, so dass nach Ansicht des Untersuchers kein relevanter Therapieeffekt der Aflibercept- Injektionen zu erwarten ist
    • Anamnese schwerwiegender Herz-Kreislaufprobleme oder eines Schlaganfalls innerhalb von 6 Monaten vor Studieneinschluss
    • Gleichzeitige Einnahme anderer VEGF-hemmender Arzneimittel innerhalb eines Monats vor Studieneinschluss (systemisch oder okulär)

    E.5 End points
    E.5.1Primary end point(s)
    Fern-Sehschärfe bei Abschlussuntersuchung (1 Monat nach der 12. Visite) im Vergleich zum Screening
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monat 12 (Ende der Studie)
    E.5.2Secondary end point(s)
    - Retinale Lichtunterschieds-Schwelle des zentralen Gesichtsfelds, gemessen mittels funduskontrollierter Mikroperimetrie
    - Angiographisch nachweisbare chorioretinale Neovaskularisation und Leckage untersucht mittels Angiographie
    - Sub- und intraretinale und subpigmentepitheliale Flüssigkeit, Ausmaß der fibrovaskulären Proliferation in der optischen Kohärenztomographie und Veränderungen im cSLO inkl. Fundus-Autofluoreszenz
    - Auftreten von AEs und SAEs
    - Änderung des Gesundheitszustandes der Gesamtpopulation, beurteilt anhand des Parameters visuelle Lebensqualität gemessen mit dem Lebensqualitätsfragebogen VFQ-25 unter Therapie mit Aflibercept
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monat 12 (Ende der Studie)
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospektiv, offen, monozentrisch, gegen historische Kontrolle
    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 trial1
    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.8.5The 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 No
    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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state15
    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)
    Nach Abschluss der klinischen Prüfung wird den Patienten eine weitere ambulante Betreuung zur Verlaufskontrolle angeboten.
    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 Decision2015-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-02
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