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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2006-004132-75
    Sponsor's Protocol Code Number:RANEOVASC-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-05
    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 number2006-004132-75
    A.3Full title of the trial
    Ensayo clínico de fase II, prospectivo, controlado, abierto, aleatorizado con grupos paralelos para comparar la seguridad y la eficacia del ranibizumab en monoterapia frente a la combinación con terapia fotodinámica con verteporfina (TFDV) en pacientes con neovascularización coroidea (NVC) subfoveal secundaria a la degeneración macular asociada a la edad (DMAE)
    A.4.1Sponsor's protocol code numberRANEOVASC-01
    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 SponsorDr. Jordi Monés
    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 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 nameRanibizumab
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 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 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 Visudyne
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma S.A.S.
    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.3.1Product nameVisudyne
    D.3.2Product code Verteporfina
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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
    NEOVASCULARIZACIÓN COROIDEA (NVC) SUBFOVEAL SECUNDARIA A LA DEGENERACIÓN MACULAR ASOCIADA A LA EDAD (DMAE)
    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
    Determinar si hay diferencias en la media del cambio de la agudeza visual (AV), a los 6 y 12 meses, respecto a la basal entre los dos grupos de tratamiento.

    Determinar si hay diferencias en el número de tratamientos entre los dos grupos de tratamiento.
    E.2.2Secondary objectives of the trial
    Detereminar si hay diferencias a los 6 y 12 meses respecto a basal entre los dos grupos de tratamiento en:la media del cambio de la agudeza visual mejor corregida (AVMC), la proporción de pacientes con mejoría de la AVMC (5, 10 y 15 letras), la proporción de pacientes con disminución de la AVMC de <15 letras, la media de cambio en el tamaño total de la lesión y en el tamaño de la NVC, el cambio medio del área de exudado, el tiempo transcurrido desde el segundo mes (tras el tratamiento de base) hasta el primer re-tratamiento, la media de cambio del grosor foveal determinado con la tomografia de coherencia óptica (OCT)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Edad igual o superior a 50 años.
    - Pacientes diagnosticados mediante angiografía fluoresceínica de NVC subfoveal secundaria a DMAE (
    - Pacientes con NVC de cualquier tipo en el ojo en estudio con las siguientes características determinadas por angiografía fluoresceínica y OCT: Evidencia de NVC que se extienda bajo el centro geométrico de la zona avascular foveal. El área de la NVC debe ocupar al menos el 50% del total de la lesión. La lesión debe tener ≤5.400 micras de diámetro mayor (DLM).
    - Para pacientes con NVC oculta sin componente clásico, la lesión debe tener presuntamente una reciente progresión a criterio del investigador y se definirá si presenta como mínimo uno de los siguientes criterios: Sangrado asociado a la lesión en el momento basal. Pérdida de agudeza visual durante los previos 3 meses definido como:
    ≥ 5 letras (Equivalente ETDRS) como se determina por el protocolo de refracción y en el protocolo de medida
    o ≥ 2 lineas del equivalente de Snellen
    o un aumento ≥ 10% en el DLM de la lesión detectado mediante angiografía fluoresceínica en los 3 meses previos.
    - Pacientes con una agudeza visual mejor corregida (MAVC) en el ojo en estudio entre 73-34 letras (aproximadamente entre 20/40 y 20/320) medida mediante ETDRS a 4 metros o equivalente de Snellen.
    - Pacientes en los que mediante OCT se muestre un engrosamiento o desprendimiento del epitelio neurosensorial de la retina.
    - Pacientes capaces de cumplir con los requisitos del estudio y sin impedimentos para seguir las instrucciones a lo largo de los 12 meses del estudio.
    - Pacientes que, tras ser informados de los objetivos y características del estudio, den su consentimiento por escrito.
    - Mujeres en edad fértil con un test negativo de embarazo antes de la inclusión en el estudio y que además utilicen método anticonceptivo eficaz durante el estudio.
    E.4Principal exclusion criteria
    -Tratamiento previo con terapia fotodinámica, radiación externa, fotocoagulación subfoveal focal con láser, cirugía submacular y termoterapia transpupilar en el ojo en estudio.
    -Estrías angioides, síndrome de presunta histoplasmosis ocular, miopía (superior a – 6 dioptrías) u otras causas de NVC diferentes a las secundarias a DMAE.
    - Tratamiento concomitante con terapia sistémica o tópica ocular con corticoesteroides. Tratamiento concomitante crónico definido como múltiples dosis diarias tomadas durante 3 ó más días consecutivos en cualquier momento durante los 3 meses previos a la selección.
    - Cataratas las cuales, a criterio del investigador, puedan progresar durante el estudio y las cuales puedan afectar a la visión del ojo.
    - Pacientes que hayan recibido previamente otro tratamiento anti-angiogénico (como por ejemplo Sandostatin®, Ruboxistaurin, Pegaptanib sódico, Ranibizumab, etc.) durante los 6 meses previos a la selección.
    - Pacientes con presencia de fibrosis, hemorragia, desprendimiento del epitelio pigmentario de la retina u otras lesiones hipofluorescentes que supongan más del 50% de la lesión.
    - Pacientes que presenten o puedan presentar a lo largo del estudio patología concomitante ocular con compromiso irreversible o que la evolución pueda comprometer la agudeza visual del ojo en estudio incluyendo ambliopía, neuropatía óptica isquémica anterior, edema macular diabético clínicamente significativo, retinopatía diabética severa no proliferativa.
    - Pacientes con glaucoma o presión intraocular ≥ 23 mmHg en el ojo en estudio.
    - Pacientes con cirugía intraocular durante los dos meses previos a la selección (incluyendo la cirugía de catarata y un mes para YAG) en el ojo en estudio.
    - Pacientes con previa administración de fármacos intravítreos (inyección o implantación) en el ojo en estudio.
    - Pacientes con hipersensibilidad conocida a la verteporfina o al ranibizumab o que presenten alguna de las contraindicaciones especificadas en las fichas técnicas de los fármacos en estudio.
    - Incapacidad para obtener fotografías documentadas de la NVC debido por ejemplo a la opacidad del medio, a la alergia a la fluoresceína o a la pérdida del acceso venoso.
    - Pacientes que estén participando o hayan participado en un ensayo clínico durante las 12 semanas previas a la inclusión.
    - Pacientes con Porfiria u otra hipersensibilidad conocida a las porfirinas
    - Pacientes con hepatopatía o hepatitis activa clínica significativa.
    - Pacientes que presenten hipertensión arterial no controlada (PAS >180 mmHg y/o PAD >100 mmHg).
    - Mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces, gestantes, con sospecha de embarazo o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Cambio medio en la agudeza visual mejor corregida (AVMC), a los 6 y al final del estudio (12 meses) respecto a la basal.
    Número de tratamientos al final del estudio (12 meses).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    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) Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    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 Decision2007-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-10
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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