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    Summary
    EudraCT Number:2007-006093-28
    Sponsor's Protocol Code Number:FIG-DMAE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-12-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-006093-28
    A.3Full title of the trial
    ENSAYO CLÍNICO, ALEATORIZADO, CONTROLADO DOBLE CIEGO, MULTICÉNTRICO PARA EVALUAR LA EFICACIA Y SEGURIDAD DEL BEVACIZUMAB (AVASTIN, Genentech, Inc.) VS RANIBIZUMAB (LUCENTIS, Genentech, Inc.) INTRAVÍTREOS EN LA DEGENERACIÓN MACULAR ASOCIADA A LA EDAD
    A.4.1Sponsor's protocol code numberFIG-DMAE
    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 SponsorFundación de Investigación Biomédica Hospital de Getafe
    B.1.3.4CountrySpain
    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 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 Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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.3.11 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) Yes
    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 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 Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.11 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) Yes
    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
    Degeneración macular asociada a la edad tipo exudativo
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025411
    E.1.2Term Macular degeneration senile
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que la eficacia y seguridad de Bevacizumab intravítreo en el tratamiento de la neovascularización coroidea (NVC) subfoveolar oculta o mínimamente clásica debida a la degeneración macular asociada a la edad (DMAE) es No Inferior a la eficacia y seguridad de Ranibizumab
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes deben cumplir todos los criterios de inclusión para ser elegibles:

    1.- pacientes de ambos sexos de 50 años o más con degeneración macular asociada a la edad tipo exudativo.

    2.- deberán presentar lesiones subfoveolares activas primarias o recurrentes con neovascularización coroidea secundaria a DMAE en el ojo de estudio.

    3.- podrán presentar todos los subtipos de NVC secundaria a DMAE.

    4.- el área total de NVC incluyendo ambos componentes clásico y oculto abarcará ≥ 50% del área total de la lesión.

    5.- el área total de la lesión debe ser de 12 áreas de disco o menos en tamaño.

    6.- grosor retiniano de 1 mm. central de al menos 300 µm en la OCT.

    7.- mejor agudeza visual en el ojo de estudio de equivalente Snellen de 20/40 a 20/400 (20 a 70 letras de los Optotipos de ETDRS a 2 metros)
    E.4Principal exclusion criteria
    No podrán ser incluidos en el estudio aquellos pacientes que presente alguno de los siguientes criterios:

    1.- pacientes con antecedentes de infarto de miocardio y accidente cerebro – vascular

    2.- pacientes con neovascularización coroidea secundaria a otros procesos tales como retino-coroiditis, miopía degenerativa, trauma o estrías angioides.

    3.- pacientes que hayan recibido tratamiento previamente con Terapia Fotodinámica con verteporfin, otro tipo de antiangiogénico, láser térmico subfoveolar, termoterapia transpupilar o radiación externa en el ojo de estudio

    4.- pacientes con tratamiento previo de Terapia Fotodinámica con verteporfin en el ojo que no entre en el estudio (contralateral) en los 7 días previos al día 0.

    5.- pacientes con tratamiento intraocular previo con otros fármacos en el ojo de estudio

    6.- láser yuxtafoveolar o extrafoveolar en el ojo de estudio en el mes previo al día 0

    7.- pacientes con antecedentes de vitrectomía en el ojo de estudio

    8.- antecedentes de cirugía submacular o cualquier otro tipo de cirugía por DMAE en el ojo de estudio

    9.- Participación en el mes previo a su inclusión en el ensayo en estudios con fármacos experimentales. No pueden incluirse pacientes tratados previamente con alguno de los fármacos en estudio.

    10.- hemorragia subretiniana en el ojo de estudio que afecta la fóvea si el tamaño es ≥ 50% del área total de la lesión o ≥1 diámetro de papila

    11.-fibrosis o atrofia subretiniana en el ojo de estudio

    12.- desgarro de epitelio pigmentario retiniano en la mácula del ojo de estudio

    13.-cualquier proceso intraocular concomitante que a juicio del investigador pudiera necesitar cirugía o tratamiento médico durante el periodo de estudio para impedir o tratar la pérdida visual resultante de tal proceso

    14.-cualquier grado de inflamación activa en el ojo de estudio

    15.- antecedentes de desprendimiento de retina regmatógeno o agujero macular en el ojo de estudio

    16.- hemorragia vítrea presente en el ojo de estudio

    17.- antecedentes de uveítis idiopática o autoinmune en cualquier ojo

    18.-conjuntivitis, queratitis, escleritis o endoftalmitis infecciosas en cualquier ojo

    19.- afaquia o pérdida de integridad de la cápsula posterior

    20.- error refractivo con un equivalente esférico en el ojo de estudio mayor a – 6 dioptrías de miopía

    21.-cirugía intraocular en el ojo de estudio en los 2 meses previos al día 0

    22.- glaucoma no controlado en el ojo de estudio (PIO ≥ 30 mm. Hg. a pesar del tratamiento antiglaucomatoso)

    23.- antecedentes de cirugía filtrante en el ojo de estudio

    24.- antecedentes de cirugía de queratoplastia en el ojo de estudio

    25.-mujeres premenopáusicas que no usen adecuada contracepción

    26.-tratamiento actual para infección sistémica activa

    27.- antecedentes de alergia a fluoresceína

    28.- incapacidad para obtener retinografías o angiogramas de suficiente calidad para ser analizados

    29.- incapacidad para cumplir con los procedimientos del estudio o del seguimiento
    E.5 End points
    E.5.1Primary end point(s)
    Criterios de eficacia
    La eficacia se determinará de acuerdo a:
    1 Principal: (%) de pacientes que pierden <de 15 letras de la escala ETDRS al mes respecto la visión en el momento del inicio
    2 Secundarios:
    -cambios en las medidas de grosor retiniano
    -número de inyecciones mensuales consecutivas para conseguir que la mácula quede libre de líquido
    -intervalo de tiempo libre de inyección
    - número de reinyecciones consecutivas requeridas para conseguir que la mácula quede libre de líquido tras reacumulo
    -relación entre tipo angiográfico de la NVC y el tamaño de la lesión con el número de inyecciones recibidas
    - total de inyecciones recibidas por un paciente en 12 meses

    Criterios de Seguridad
    La seguridad se evaluará con referencia a lo siguiente:
    1. Locales
    • Incidencia de:progresión de cataratas,
    • daño del cristalino,
    • aumento de la presión intraocular
    • roturas retinianas
    • hemorragia vítrea
    • endolftalmitis
    • Número de pacientes (%) que dejan el estudio debido a AA
    2. Sistémicos
    • Fenómenos tromboembolicos cardíacos, cerebrales o periféricos y
    • hemorrágicos
    • Valores de Seguridad de laboratorio
    • Signos clínicos vitales
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Lucentis
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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 state270
    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 Decision2008-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-10
    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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