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    Summary
    EudraCT Number:2019-000946-37
    Sponsor's Protocol Code Number:2019-06
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-000946-37
    A.3Full title of the trial

    Molecular imaging exploration of ocular angiogenic activity and evaluation of its relevance in the therapeutic follow-up of AMD patients.
    Exploration par imagerie moléculaire de l’activité angiogénique oculaire et évaluation de son intérêt dans le suivi thérapeutique de patients atteints de DMLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language

    Molecular imaging exploration of ocular angiogenic activity and evaluation of its relevance in the therapeutic follow-up of AMD patients.
    Exploration par imagerie moléculaire de l’activité angiogénique oculaire et évaluation de son intérêt dans le suivi thérapeutique de patients atteints de DMLA
    A.3.2Name or abbreviated title of the trial where available
    DMLA-RGD
    DMLA-RGD
    A.4.1Sponsor's protocol code number2019-06
    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 SponsorAssistance Publique-Hôpitaux de Marseille
    B.1.3.4CountryFrance
    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 supportAssistance Publique-Hôpitaux de Marseille
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique-Hôpitaux de Marseille
    B.5.2Functional name of contact pointDirection de la Recherche Santé
    B.5.3 Address:
    B.5.3.1Street Address80, rue Brochier
    B.5.3.2Town/ cityMarseille cedex 05
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number+33491382747
    B.5.5Fax number+33491381479
    B.5.6E-mailcamille.delannoy@ap-hm.fr
    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 name68Ga-NODAGA-RGD
    D.3.2Product code 68Ga-RGD
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    Age-related macular degeneration
    Dégénérescence maculaire liée à l'âge
    E.1.1.1Medical condition in easily understood language
    Age-related macular degeneration (AMD)
    Dégénérescence maculaire liée à l'âge (DMLA)
    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 10025409
    E.1.2Term Macular degeneration
    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 main objective of this project is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in 20 patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the induction phase (after 3 months of treatment).
    L’objectif principal de cette étude pilote consiste à évaluer la capacité de l’imagerie TEP 68Ga-NODAGA-RGD à mettre en évidence, chez des patients atteints de DMLA unilatérale, une réponse thérapeutique moléculaire aux injections antiangiogéniques intraoculaires au terme de la phase d’induction (après 3 mois de traitement).
    E.2.2Secondary objectives of the trial
    - Measure the links between the intensity of the PET signal at 68Ga-NODAGA-RGD (SUVmax) and the retinal thickness measured by OCT, for each eye, before treatment and after the 6th intraocular injection of antiangiogenic agent

    - Measure the links between the intensity of the PET signal at 68Ga-NODAGA-RGD (SUVmax) and each of the psychometric scales for measuring visual acuity (ETDRS scale and Parinaud scale), for each eye, before treatment and after treatment. 6th intraocular injection of antiangiogenic agent
    - Mesurer les liens entre l’intensité du signal en TEP au 68Ga-NODAGA-RGD (SUVmax) et l’épaisseur rétinienne mesurée par OCT, pour chaque œil, avant traitement et après la 6e injection intraoculaire d’antiangiogénique

    - Mesurer les liens entre l’intensité du signal en TEP au 68Ga-NODAGA-RGD (SUVmax) et chacune des échelles psychométriques de mesure de l’acuité visuelle (échelle ETDRS et échelle Parinaud), pour chaque œil, avant traitement et après la 6e injection intraoculaire d’antiangiogénique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years old, membership of a social security scheme.
    - Signature of informed consent,
    - Subject with unilaterally affected AMD with at least 1 focus of choroidal neovascularization objectified in OCT, naïve to any antiangiogenic treatment.
    - Initial workup including at least OCT and visual acuity measurement, no more than 1 month old at the time of the 68Ga-NODAGA-RGD PET scan.
    • Age ≥ 18 ans, affiliation à un régime de sécurité sociale.
    • Signature du consentement éclairé,
    • Sujet présentant une DMLA avec atteinte unilatérale, portant au moins 1 foyer de néovascularisation choroïdienne objectivé en OCT, naïf de tout traitement antiangiogénique.
    • Bilan initial comprenant au minimum OCT et mesure de l’acuité visuelle, datant de maximum 1 mois au moment de la TEP au 68Ga-NODAGA-RGD.
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding women, as a radiation protection measure.
    - Subjects under 18 years of age and/or not affiliated to a social security scheme.
    - Subjects with bilateral AMD.
    - Subjects presenting an AMD without neovascularization focus as determined by the classical diagnostic scheme.
    - Subjects who have already been treated with antiangiogenic therapy.
    - Subjects with any other ophthalmologic pathology.
    - Monophthalmic subjects.
    • Les femmes enceintes ou en cours d'allaitement, par mesure de radioprotection.
    • Les sujets de moins de 18 ans et/ou non affiliés à un régime de sécurité sociale.
    • Les sujets présentant une DMLA avec atteinte bilatérale.
    • Les sujets présentant une DMLA sans foyer de néovascularisation objectivé par la batterie diagnostique classique.
    • Les sujets ayant déjà été traités par thérapie antiangiogénique.
    • Les sujets atteints de toute autre pathologie ophtalmologique.
    • Les sujets monophtalmiques.
    E.5 End points
    E.5.1Primary end point(s)
    The ratios of the PET signal intensities (SUVmax) eye AMD / eye contralateral to M0 and to M4 will be compared by a comparison test of paired means.
    Les ratios des intensités du signal TEP (SUVmax) œil DMLA/œil controlatéral à M0 et à M4 seront comparés par un test de comparaison des moyennes appariées.
    E.5.1.1Timepoint(s) of evaluation of this end point
    M0 and M4
    M0 et M4
    E.5.2Secondary end point(s)
    The links between PET signal strength (SUVmax) and retinal thickness measured by OCT, for each eye, will be documented at M0 and M4, respectively, by a correlation study.

    The links between the intensity of the PET signal (SUVmax) and the visual acuity score measured with each of the psychometric scales (ETDRS and Parinaud), for each eye, will be documented respectively at M0 and M4 by a correlation study.
    Les liens entre l’intensité du signal TEP (SUVmax) et l’épaisseur rétinienne mesurée par OCT, pour chaque œil, seront documentés respectivement à M0 et à M4 par une étude de corrélation.

    Les liens entre l’intensité du signal TEP (SUVmax) et le score d’acuité visuelle mesuré avec chacune des échelles psychométriques (ETDRS et Parinaud), pour chaque œil, seront documentés respectivement à M0 et à M4 par une étude de corrélation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    M0 and M4
    M0 et M4
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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 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 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 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
    Dernière visite du dernier patient
    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 months27
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-08-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    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 Decision2020-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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