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    Summary
    EudraCT Number:2018-003863-67
    Sponsor's Protocol Code Number:FME_2018_9
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-11-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003863-67
    A.3Full title of the trial
    Multicenter randomized controlled trial on the interest of intravitreal injections of anti-VEGF as initial and adjuvant treatment in Coats disease
    Étude contrôlée randomisée multicentrique sur l’intérêt des injections intra-vitréennes d’anti-VEGF comme traitement initial puis adjuvant dans la maladie de Coats
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter randomized controlled trial on the interest of intravitreal injections of anti-VEGF as initial and adjuvant treatment in Coats disease
    Étude contrôlée randomisée multicentrique sur l’intérêt des injections intra-vitréennes d’anti-VEGF comme traitement initial puis adjuvant dans la maladie de Coats
    A.3.2Name or abbreviated title of the trial where available
    COATS-VEGF
    COATS-VEGF
    A.4.1Sponsor's protocol code numberFME_2018_9
    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 SponsorFondation Ophtalmologique Adolphe de Rothschild
    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 supportFrench Ministry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondation Adolphe de Rothschild
    B.5.2Functional name of contact pointUnité de Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street AddressUnité de Recherche Clinique
    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 Avastin® (bevacizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 infusion
    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
    Coats disease
    Maladie de Coats
    E.1.1.1Medical condition in easily understood language
    Coats disease
    Maladie de Coats
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of intravitreous injection (IVT) of anti-VEGF (bevacizumab, Avastin®) on the stage of Coats disease, compared to the reference treatment by laser photocoagulation, 6 months after initiation study treatment.
    Comparer l’efficacité du traitement par injection intra-vitréenne (IVT) d’anti-VEGF (bevacizumab, Avastin®) sur le stade de la maladie de Coats, par rapport au traitement de référence par photocoagulation laser, 6 mois après l’initiation du traitement d’étude.
    E.2.2Secondary objectives of the trial
    Compare the efficacy of anti-VEGF IVTs (bevacizumab, Avastin®) as an initial and adjuvant treatment for laser photocoagulation versus laser photocoagulation alone at 2 months, 4 months and 9 months after initiation of treatment study.

    Evaluate the tolerance of intravitreous injections of bevacizumab.
    Comparer l’efficacité des IVT d’anti-VEGF (bevacizumab, Avastin®) comme traitement initial puis adjuvant des séances de photocoagulation laser versus un traitement par photocoagulation laser seul, à 2 mois, 4 mois et 9 mois après l’initiation du traitement d’étude.

    Évaluer la tolérance des injections intra-vitréenne de bevacizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient ≤ 16 years old
    - Coats disease confirmed by fundus examination and fluorescein angiography
    - Stage 2 or 3 at the fundus (Shields classification) on at least 2 quadrants
    - Naïve to any eye treatment on the eye affected by Coats disease
    -Patient ≤ 16 ans
    -Maladie de Coats confirmée par l’examen au fond d’œil et à l’angiographie à la fluorescéine
    -Stades 2 ou 3 au fond d’œil (classification de Shields) sur au moins 2 quadrants
    -Naïf de tout traitement oculaire sur l’œil atteint par la maladie de Coats
    E.4Principal exclusion criteria
    - Other ocular pathology on the eye affected by Coats' disease
    - Bilateral forms of the disease
    - History of hypersensitivity to bevacizumab
    - History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
    - Allergic reaction in a previous fluorescein retinal angiogram
    - Pregnancy or breastfeeding
    -Autre pathologie oculaire sur l’œil atteint par la maladie de Coats
    -Formes bilatérales de la maladie
    -Antécédent d’hypersensibilité au bevacizumab
    -Antécédents d’hypersensibilité aux produits des cellules ovariennes de hamster Chinois (CHO) ou à d’autres anticorps recombinants humains ou humanisés
    -Réaction allergique lors d’une précédente angiographie rétinienne à la fluorescéine
    -Grossesse ou allaitement
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with improvement of at least one stage of the disease according to the Schields classification (Am J Ophthalmol, 2001), 6 months after initiation of study treatment.
    Proportion de patients ayant une amélioration d’au moins un stade de la maladie selon la classification de Schields (Am J Ophthalmol, 2001), 6 mois après la l’initiation du traitement à l’étude.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after initiation of study treatment.
    6 mois après la l’initiation du traitement à l’étude
    E.5.2Secondary end point(s)
    -Comparison, between the 2 groups, of the proportion of patients having an improvement of at least one stage of the Shields classification evaluated with retinal multimodal imaging by two independent experts at 2 months, 4 months and 9 months after initiation of study treatment.

    -Comparison between the 2 groups of each of the items defining the Shields stage at 2, 4, 6 and 9 months after the initiation of the study treatment: presence of telangiectasia, presence of exudates, presence of a retinal detachment; glaucoma, bulbous phtyse.

    -Comparison between the 2 groups of visual acuity (expressed in logmar) 4, 6 and 9 months after the initiation of the study treatment, in children of verbal age (from 3 years).

    -Comparison between the 2 groups of the variation of macular thickness (in micrometer), the presence of a serous uplift and the maximal thickness of fibrosis observed with optical coherence tomography at 2, 4, 6 and 9 months after the initiation of the study treatment for the children in whom it was made.

    -Comparison between the 2 groups of the number of patients for whom a complementary treatment (ie additional laser session - beyond the 3rd session - or surgical treatment) was necessary 9 months after the initiation of the study treatment.

    -Comparison between the 2 groups of the number of events and adverse effects (ie: passage to stage 5 (phtyse), need for surgical treatment, cataract, vitreoretinal fibrosis, detachment of functional retina as well as any serious adverse event detected by the investigator leading to discontinuation of treatment).
    -Comparaison, entre les 2 groupes, de la proportion de patients ayant une amélioration d’au moins un stade de la classification de Shields évaluée à l’imagerie multimodale rétinienne par deux experts indépendants à 2 mois, 4 mois et 9 mois après l’initiation du traitement d’étude.

    -Comparaison entre les 2 groupes de chacun des items définissant le stade Shields à 2, 4, 6 et 9 mois après l’initiation du traitement d’étude : présence de télangiectasies, présence d’exsudats, présence d’un décollement de rétine ; glaucome, phtyse bulbaire.

    -Comparaison entre les 2 groupes de l’acuité visuelle (exprimée en logmar) 4, 6 et 9 mois après l’initiation du traitement d’étude, chez les enfants en âge verbal (à partir de 3 ans).

    -Comparaison entre les 2 groupes de la variation d’épaisseur maculaire (en micromètre), de la présence d’un soulèvement séreux et de l’épaisseur maximale de fibrose observée à la tomographie par cohérence optique à 2, 4, 6 et 9 mois après l’initiation du traitement d’étude pour les enfants chez qui il aura été réalisé.

    -Comparaison entre les 2 groupes du nombre de patients pour lesquels un traitement complémentaire (c’est-à-dire séance de laser supplémentaire - au-delà de la 3ème séance - ou traitement chirurgical) a été nécessaire 9 mois après l’initiation du traitement d’étude.

    -Comparaison entre les 2 groupes du nombre d’évènements et d’effets indésirables (c’est-à-dire : passage en stade 5 (phtyse); nécessité d’un traitement chirurgical ; cataracte ; une fibrose vitréo-rétinienne ; décollement de rétine tractionnel ainsi que tout évènement indésirable grave détecté par l’investigateur et entraînant l’arrêt du traitement).
    E.5.2.1Timepoint(s) of evaluation of this end point
    2, 4, 6 and 9 months after initiation of study treatment.
    2, 4, 6 et 9 mois après l’initiation du traitement à l'étude
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    laser photocoagulation
    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 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
    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 years2
    E.8.9.1In the Member State concerned months10
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    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
    Subjects under age incapable of giving consent personally
    Sujets mineurs n'ayant pas la capacité juridique de donner leur consentement
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 : expected normal treatment
    Aucun : traitement habituel
    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 Decision2019-01-25
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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