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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-003208-68
    Sponsor's Protocol Code Number:HCL/P 2007.467/10
    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:2008-06-20
    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 number2008-003208-68
    A.3Full title of the trial
    Groupe d’Evaluation Français Avastin® versus Lucentis®
    A.3.2Name or abbreviated title of the trial where available
    GEFAL
    A.4.1Sponsor's protocol code numberHCL/P 2007.467/10
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospices Civils de Lyon
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma SAS
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Information not present in EudraCT
    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-
    D.3.9.3Other descriptive nameEV code : SUB22314
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Information not present in EudraCT
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-
    D.3.9.3Other descriptive nameEV code SUB16402MIG
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Dégénérescence Maculaire Liée à l’Age (DMLA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Montrer la non-infériorité en terme d’efficacité clinique à 12 mois du bevacizumab par rapport au ranibizumab sur l’acuité visuelle de patients atteints de DMLA néovasculaire rétrofovéolaire
    E.2.2Secondary objectives of the trial
    - Evaluer et comparer l’efficacité des traitements par bevacizumab et ranibizumab en terme :
    * D’impact sur l’acuité visuelle
    * De diminution de la taille de la lésion néovasculaire
    * De disparition de la zone de diffusion
    * D’amélioration des critères OCT

    - Evaluer et comparer la tolérance des traitements par bevacizumab et ranibizumab au niveau local et systémique

    - Décrire et comparer les schémas posologiques (nombre d’injections et délai de réinjection) dans les deux groupes

    - Réaliser une étude du profil pharmacocinétique des médicaments

    - Réaliser une modélisation médico-économique de l’impact lié à l’intervention thérapeutique, à partir des résultats des 2 groupes de randomisation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient d’âge > ou égal à 50 ans.

    - Présentant une DMLA néovasculaire de localisation rétrofovéolaire

    - Meilleure acuité visuelle corrigée pour l’œil étudié comprise entre 20/32 (6,3/10ème) et 20/320 (0,6/10ème), en échelle ETDRS, à une distance initiale de 4 m.

    - Taille de la lésion < ou égale à 4 diamètres papillaires (DP) dans sa plus grande dimension linéaire (soit < ou égale à 6000 µm).

    - En cas de néovaisseaux occultes isolés ou prédominants, nécessité de la notion d’une évolutivité récente de la lésion : baisse de l’acuité visuelle d’au moins une ligne Snellen (ou équivalent) dans les 6 derniers mois OU apparition d’une hémorragie sous-rétinienne associée à un néovaisseau choroïdien au cours du dernier mois OU augmentation de taille de la lésion (> 10%) à l’angiographie fluorescéïnique au cours du dernier mois par comparaison aux 6 derniers mois OU apparition de critères OCT à type d’œdème maculaire, de décollement séreux du neuro-épithélium, de décollement de l’épithélium pigmenté au cours du dernier mois.
    E.4Principal exclusion criteria
    - Traitement antérieur ou en cours de la DMLA par injection intravitréenne d’anti-VEGF (ranibizumab, bevacizumab ou pegaptanib) dans l’œil étudié.

    - Autre traitement curatif de la DMLA dans l’œil étudié dans les 3 mois précédant la première injection intravitréenne : laser maculaire juxta- ou extra-fovéolaire, photothérapie dynamique (PDT), chirurgie, radiothérapie externe, thermothérapie transpupillaire…

    - Antécédent de photocoagulation laser maculaire focale rétrofovéolaire de l’œil étudié.

    - Traitement de l’œil non étudié par PDT dans les 7 jours précédant la première injection intravitréenne dans l’œil étudié.

    - Participation en cours du patient à un autre essai clinique (œil étudié et/ou œil non étudié).

    - Présence d’une hémorragie sous rétinienne atteignant le centre de la fovéa, de taille > ou égale à 50% de la surface de la lésion.

    - Fibrose ou atrophie rétinienne rétrofovéolaire de l’œil étudié.

    - Déchirure de l’épithélium pigmenté rétinien atteignant la macula de l’œil étudié.

    - Néovascularisation choroïdienne non liée à une DMLA (myopie forte > - 6D, stries angioïdes, traumatisme oculaire, pseudo histoplasmose, choroïdite multifocale…).

    - Antécédent de dispositifs intravitréens dans l‘œil étudié.

    - Infection oculaire ou périoculaire active ou suspectée.

    - Inflammation intraoculaire active sévère.

    - Antécédent d’uvéite auto-immune ou idiopathique.

    - Rétinopathie diabétique avérée.

    - Pression intraoculaire > 30 mmHg malgré deux traitements hypotonisants.

    - Antécédent de chirurgie intraoculaire autre (chirurgie de la cataracte, chirurgie du décollement de rétine, de kératoplastie …) dans les 2 mois précédant la première injection intravitréenne dans l’œil étudié.

    - Aphakie ou absence de capsule postérieure (autre que la capsulotomie au laser Yag) dans l’œil étudié.

    - Toute maladie ou condition oculaire de l’œil étudié qui pourrait selon l’investigateur avoir besoin d’une chirurgie intraoculaire dans les 12 mois ou qui pourrait abaisser l’acuité visuelle de plus de 2 lignes équivalent Snellen au cours des 12 mois.

    - Hypersensibilité connue au ranibizumab, au bevacizumab ou à l’un des excipients ; allergie connue à la fluorescéine, au vert d’indocyanine et aux collyres anesthésiques.

    - Hypertension artérielle non contrôlée par un traitement approprié

    - Antécédent de traitement ou traitement en cours par bevacizumab par voie systémique.

    - Suivi impossible durant 12 mois.

    - Patient non affilié à un régime de sécurité sociale ou non bénéficiaire d'un tel régime.
    E.5 End points
    E.5.1Primary end point(s)
    Variation de l’acuité visuelle moyenne en nombre de lettres gagnées ou perdues entre l’inclusion et 12 mois post initiation du traitement, l’acuité visuelle étant mesurée sur l’échelle « Early Treatment Diabetic Retinopathy Study » (ETDRS), à une distance initiale de 4 mètres
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 Information not present in EudraCT
    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
    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 months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 state600
    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 Decision2008-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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