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    Summary
    EudraCT Number:2012-004758-27
    Sponsor's Protocol Code Number:V1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-004758-27
    A.3Full title of the trial
    fMRI analysis of the visual cortex in neovascular age-related macular degeneration
    fMRT Analyse des visuellen Kortex bei neovaskulärer altersbedingter Makuladegeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Activity patterns of the cortical optic area in wet age-related macular degeneration patients
    Aktivitätsmuster der Sehrinde bei Patienten mit feuchter AMD
    A.4.1Sponsor's protocol code numberV1
    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 Universität Wien, Universitätsklinik für Augenheilkunde
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Augenheilkunde, Medizinische Universität Wien
    B.5.2Functional name of contact pointWiener Studien Zentrum
    B.5.3 Address:
    B.5.3.1Street AddressWähringergürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404004847
    B.5.5Fax number00431404007932
    B.5.6E-mailmarion.munk@meduniwien.ac.at
    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 Lucentis 10 mg/ml Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLucentis
    D.3.2Product code RFB002
    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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    20 patients with neovascular age-related macular degeneration will be examined before and after 3 monthly administered intravitreal ranibizumab injections according to the label with 7 tesla magnetic resonance tomography and microperimetry. 20 healthy participants serve as control group and will be examined once
    20 Patienten mit neovaskulärer AMD werden jeweils vor- und nach dreimaliger intravitrealer Ranibizumab Injektion im monatlichen Abstand entsprechend der EMA-Zulassung mit 7 Tesla MRT untersucht. 20 gesunde Teilnehmer fungieren als Kontrollen und erhalten eine einmalige 7 Tesla MRT-Untersuchung
    E.1.1.1Medical condition in easily understood language
    Activity patterns of the cortical optic area will be examined before and after Lucentis treatment with MRI in patients with wet AMD
    Die Aktivitätsmuster der Sehrinde werden vor und nach Lucentistherapie bei Patienten mit feuchter AMD mittels MRT getestet.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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 evaluate the activation pattern of the primary visual cortex in nAMD patients before and after ranibizumab therapy and to compare it with healthy controls.
    Evaluation der Aktivierungsmuster des primären visuellen Kortex bei nAMD Patienten vor- und nach Ranibizumab Therapie und Vergleich mit gesunden Kontrollen
    E.2.2Secondary objectives of the trial
    1.Comparison of central retinal sensitivity patterns with retinotopic maps
    2.Comparison of retinotopic maps of the primary visual cortex in untreated nAMD with retinotopic maps after initial ranibizumab therapy
    3.Comparison of retinotopic maps of healthy controls with retinotopic maps of neovascular AMD patients
    4.Evaluation of visual signal processing in nAMD compared to healthy controls
    5.Correlation of absolute retinal scotoma location to associated cortical activity
    1. Vergleich der zentralen retinalen Sensitivität und des zentralen Gesichtsfeldes mit den retinotopischen Mappen
    2. Vergleich der retinotiopischen Mappen des primär visuellen Kortex vor und nach iuntravitrealer Ranibizumab Therapie
    3. Vergleich der retinotopischen Mappen gesunder Kontrollen mit den retinotopischen Mappen von Patienten mit neovaskulkärer AMD
    4. Evaluation der Signaltransfuktion bei neovaskulärer AMD im Vergleich zu gesunden Kontrollen
    5. Korrelation der absoluten Skotome mit den Aktivitätsmustern des primär visuellen Kortex bei neovaskulärer AMD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients 50 years of age or older
    • ability to read
    • mastering the German language
    • signing the informed consent
    • (for patients): new onset, treatment naive sub-or juxtafoveal choroidal neovascularization caused by AMD
    • (for patients) Visual Acuity of 20/400-20/40
    • (for healthy controls): Visual Acuity of 20/16- 20/30
    -Lesefähigkeit
    -der deutschen Sprache mächtig
    -unterzeichnete Einwilligungserklärung
    - > 50 Jahre,
    - (im Fall von Patienten): Patienten mit neu aufgetretener, durch neovaskulärere AMD bedingte sub- oder juxtafovealer choroidaler Neovaskularisation, keine bisherige Therapie durch Laser oder intravitrealer Injektionen, Visual acuity von 20/400-20/40,

    -(im Fall von Probanden): Visual acuity 20/16- 20/30
    E.4Principal exclusion criteria
    • (for patients): Any prior initial intravitreal treatment or previous laser treatment
    • (for healthy controls): presence of any retinal and/or optic nerve disease
    • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation).
    • Aphakia or absence of the posterior capsule in the study eye.
    • Cataract > grade 2 (according to lens opacities system)
    • Amblyopia
    • Active intraocular inflammation (grade trace or above) in the study eye
    • All exclusion criteria that apply to MRI scans: Pacemaker, metal debris, metalliferous coil, claustrophobia
    • Pregnancy
    • Dyslexia
    alle Exklusionskriterien, die für jeweilige MRT-Untersuchungen gelten: Herzschrittmacher, Metallfremdkörper, metallhaltige Spirale, Klaustrophobie, Schwangerschaft,
    -Amblyopie
    -Dyslexie
    - unkontrollierbares Glaukom (intraokularer Druck >= 25 mmHg trotz Glaukommedikation)
    - Katarakt > Grad 2 (lens opacities system)
    -Aphakie oder Fehlen der hinteren Kapsel im Studienauge
    - aktive intraokuläre Entzündung
    -(im Fall von Patienten): bereits erhaltene Therapie (intravitreal/Laser) gegen neovaskuläre AMD
    -(im Fall von Probanden): Erkrankungen der Netzhaut oder des Sehnervens
    E.5 End points
    E.5.1Primary end point(s)
    1.Retinotopic maps of nAMD patients and healthy controls.
    2.Change of the activity patterns of the primary visual cortex in nAMD patients after ranibizumab treatment
    1.Retinotopische Mappen gesunder Kontrollen und Patienten mit neovaskulärer AMD vor und nach Therapie
    2.Unterschiede der Aktivitätsmuster des primär visuellen Kortex vor und nach Therapie bei Patienten mit neovaskulärer AMD
    E.5.1.1Timepoint(s) of evaluation of this end point
    progressive
    Fortlaufend
    E.5.2Secondary end point(s)
    1.Difference of the activation patterns of the primary visual cortex in healthy controls and in nAMD patients before and after intravitreal anti-VEGF
    2.Evaluation of potential plasticity of the primary visual cortex in nAMD patients
    3.Comparison of retinotopic maps of healthy controls with retinotopic maps of neovascular AMD patients
    4.Correlation of absolute retinal scotoma location to associated cortical activity
    1. Unterschiede der Aktivitätsmuster des primären visuellen Kortex vor und nach intravitrealem ranibizumab
    2. Evaluation potenzieller Plastizität des primär visuellen Kortex bei Patienten mit neovaskulärer AMD
    3. Vergleich retinotopischer Mappen gesunder Kontrollen mit retinotopischen Mappen von Patienten mit neovaskulärer AMD
    4. Korrelation absoluter Skotome mit kortikalen Aktivitätsmustern
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuous
    fortlaufend
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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.8.3 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 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
    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 months18
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state40
    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)
    After the end of the study patients will befurther observed at the Department of Ophthalmology and Optometry, Medical University Vienna according to current standards
    Nach Beendigung der Studie werden alle Patienten an der Universitätsklinik für Augenheilkunde nach state-of the art weiterbetreut
    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 MRT Exzellenzzentrum
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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