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    Summary
    EudraCT Number:2020-005449-18
    Sponsor's Protocol Code Number:MMT_2020_33
    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:2020-12-10
    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 number2020-005449-18
    A.3Full title of the trial
    Spontaneous retinal artery pulses as a prognostic determinant of central retinal vein occlusions in patients with and without intravitreal aflibercept injections.
    Pulsations artérielles rétiniennes spontanées (PARS) en tant que déterminant pronostique des occlusions de la veine centrale de la rétine (OVCR) chez les patients traités ou non par injections intravitréennes d’aflibercept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Spontaneous retinal artery pulses as a prognostic determinant of central retinal vein occlusions in patients with and without intravitreal aflibercept injections
    Pulsations artérielles rétiniennes spontanées (PARS) en tant que déterminant pronostique des occlusions de la veine centrale de la rétine (OVCR) chez les patients traités ou non par injections intravitréennes d’aflibercept
    A.3.2Name or abbreviated title of the trial where available
    PULSOV
    PULSOV
    A.4.1Sponsor's protocol code numberMMT_2020_33
    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 SponsorHôpital Fondation A. de Rothschild / Service de recherche clinique
    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 supportBayer Healthcare
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Fondation A. de Rothschild / Service de recherche clinique
    B.5.2Functional name of contact pointAdministrative Coordinator
    B.5.3 Address:
    B.5.3.1Street Address29 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.4Telephone number+33148036433
    B.5.6E-mailpvachey@for.paris
    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 40 mg/mL, solution injectable en seringue préremplie
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER AG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPIntraocular 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) 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
    Central retinal vein occlusions
    Occlusions de la veine centrale de la rétine (OVCR)
    E.1.1.1Medical condition in easily understood language
    Central retinal vein occlusions
    Occlusions de la veine centrale de la rétine (OVCR)
    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 compare the evolution of visual acuity between inclusion and visit at one year in patients with retinal central vein occlusion with retinal central artery pulsating versus without retinal central artery pulsating
    Comparer l’évolution de l’acuité visuelle entre l’inclusion et la visite à un an chez les patients présentant une occlusion de la veine centrale de la rétine avec pulsation de l'artère centrale de rétine versus sans pulsation de l'artère centrale de rétine
    E.2.2Secondary objectives of the trial
    Comparison between PARS+ and PARS- patients at inclusion :
    1. Percentages of patients with macular edema during the first year of follow-up;
    2. changes in macular thickness between diagnosis and visit at 1 year;
    3. Percentages of occurrence of OVCR-related complications during the first year of follow-up (neovascular glaucoma or intravitreal hemorrhage);
    4. Number of aflibercept injections during the first year of follow-up (only for patients treated with aflibercept);
    5. Mean time between the last 2 aflibercept injections (only for patients treated with aflibercept).

    Exploratory analysis of various parameters measured by Colour Doppler Ultrasound of the orbit and optic nerve at the acute phase of OVCR and at 1 year, including subgroup analyses based on the presence or absence of PARS at baseline, for patients managed at the A. de Rothschild Foundation Hospital.
    Comparaison entre les patients PARS+ et PARS- à l’inclusion :
    1. des pourcentages de patients ayant présenté un œdème maculaire durant la première année de suivi ;
    2. des évolutions de l’épaisseur maculaire entre le diagnostic et la visite à 1 an ;
    3. des pourcentages de survenue de complications en rapport avec l’OVCR durant la première année de suivi (glaucome néovasculaire ou hémorragie intravitréenne) ;
    4. des nombres d’injections d’aflibercept durant la première année de suivi (uniquement pour les patients traités par aflibercept);
    5. des délais moyens entre les 2 dernières injections d’aflibercept (uniquement pour les patients traités par aflibercept).

    Analyse exploratoire des différents paramètres mesurés à l’Échographie Doppler Couleur de l’orbite et du nerf optique à la phase aigüe de l’OVCR et à 1 an, incluant des analyses en sous-groupe en fonction de la présence ou non de PARS à l’inclusion, pour les patients pris en charge à l’Hôpital Fondation A. de Rothschild.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years of age
    - Diagnosis of OVCR, with or without macular edema.
    - Onset of symptoms in the previous month (maximum 30 days prior to inclusion)
    - Naive intravitreal injection and intravitreal corticosteroid implant
    - Affiliate or beneficiary of a Health Insurance plan
    - Having received informed information about the study and having signed a consent to participate in the study
    - If woman of childbearing age: commitment to effective contraception during treatment with aflibercept and for at least 3 months after the last intravitreal injection of aflibercept
    - Patient âgé de plus de 18 ans
    - Diagnostic d’OVCR, avec ou sans œdème maculaire.
    - Apparition des symptômes le mois précédent (maximum 30 jours avant l’inclusion)
    - Naïf d’injection intra vitréenne et d’implant intravitréen de corticoïdes
    - Affilié ou bénéficiaire d’un régime d’Assurance Maladie
    - Ayant reçu une information éclairée sur l’étude et ayant signé un consentement de participation à l’étude
    - Si femme en âge de procréer : engagement pour une contraception efficace pendant le traitement par aflibercept et pendant au moins 3 mois après la dernière injection intravitréenne d’aflibercept
    E.4Principal exclusion criteria
    - Patient benefiting from a legal protection measure
    - Pregnant or breastfeeding woman
    - History of stroke or myocardial infarction in the last 3 months
    - Retinal detachment or untreated retinal dehiscence
    - Opacity of ocular media
    - Amblyopia
    - Diabetic retinopathy
    - Macular edema of a different etiology than OVCR
    - Active or suspected ocular or periocular infection
    - Severe intraocular inflammation
    - Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients
    - Patient bénéficiant d’une mesure de protection juridique
    - Femme enceinte ou allaitant
    - Antécédent d’accident vasculaire cérébral ou d’infarctus du myocarde dans les 3 derniers mois
    - Décollement de rétine ou déhiscence rétinienne non traitée
    - Opacités des milieux oculaires
    - Amblyopie
    - Rétinopathie diabétique
    - Œdème maculaire d’une autre étiologie que l’OVCR
    - Infection oculaire ou périoculaire active ou suspectée
    - Inflammation intraoculaire sévère
    - Hypersensibilité à l’EYLEA® : à la substance active (aflibercept) ou à l’un des excipients
    E.5 End points
    E.5.1Primary end point(s)
    The evolution of visual acuity (BCVA on ETDRS scale) in letters read and validated between the beginning of the treatment and 1 year.
    Infrared films will be made at inclusion from the Heidelberg Spectralis device (Heidelberg Engineering Germany). Two ophthalmologists blinded to each other will view the films. The arterial pulses are visualized at the optic papilla in the form of pulse-dependent beats of the arterial walls. For each film each ophthalmologist will give his assessment: PARS+ or PARS-. In case of discrepancy, a third ophthalmological opinion will be requested.
    L’évolution de l’acuité visuelle (BCVA sur échelle ETDRS) en lettres lues et validées entre le début de la prise en charge et 1 an.
    Des films infrarouges seront réalisés à l’inclusion à partir de l’appareil Spectralis Heidelberg (Heidelberg Engineering Germany). Deux ophtalmologistes en aveugle l’un de l’autre visualiseront les films. Les pulsations artérielles sont visualisées au niveau de la papille optique sous forme de battements des parois artérielles en fonction du pouls. Pour chacun des films chaque ophtalmologiste donnera son appréciation : PARS+ ou PARS-. En cas de discordance, un troisième avis ophtalmologique sera demandé.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 an
    E.5.2Secondary end point(s)
    1. Macular edema will be determined by the ophthalmologist based on the OCT examination ;
    2. The measurement of macular thickness in µm will be carried out using a measurement software integrated in the OCT
    3. Complications of OVCR will be collected at one year from the patient's chart;
    4. The number of injections of aflibercept during the first year of follow-up will be collected at one year from the patient's chart ;
    5. The time between the last 2 injections of aflibercept will be collected at one year from the patient's chart.
    1. L’œdème maculaire sera déterminé par l’ophtalmologiste à partir de l’examen OCT ;
    2. La mesure de l’épaisseur maculaire en µm sera réalisée grâce à un logiciel de mesure intégré à l’OCT
    3. Les complications de l’OVCR seront recueillies à un an à partir du dossier du patient;
    4. Le nombre d’injections d’aflibercept durant la première année de suivi sera recueillie à un an à partir du dossier du patient ;
    5. Le délai entre les 2 dernières injections d’aflibercept sera recueilli à un an à partir du dossier du patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 an
    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 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
    Pathophysiology: The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (PARS) in patients with type A or B OVCR can be considered as a prognostic factor in the evolution of OVCR. The study drug is only used to standardize treatment and to have comparable groups with and without PARS.
    Physiopathologie : L’objectif de cette étude est de rechercher en prospectif, si les pulsations artérielles rétiniennes spontanées (PARS) des patients atteints d’OVCR de type A ou B, peuvent être considérées comme un facteur pronostique de l’évolution des OVCR. Le médicament de l'étude sert uniquement à standardiser le traitement et à avoir des groupes comparables avec et sans PARS
    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 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
    Last visit of last patient
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 50
    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 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 state60
    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
    Aucun
    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 Decision2021-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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