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    Summary
    EudraCT Number:2012-001781-15
    Sponsor's Protocol Code Number:IOBA-04-2012
    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:2012-05-29
    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 number2012-001781-15
    A.3Full title of the trial
    Initial protocol setting for the treatment of choroidal neovascularization associated to myopia magna with intravitreal bevacizumab: 3 vs 1 (BENEMCOR.es study)
    Establecimiento del protocolo inicial en el tratamiento de la neovascularización coroidea asociada a la miopía magna con inyección intravítrea de bevacizumab: 3 vs 1 (Estudio BENEMCOR.es)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    protocol for treatment of choroidal neovascularization associated to myopia magna intravitreal bevacizumab
    protocolo de tratamiento de la neovascularización coroidea asociada a la miopía magna bevacizumab intravítreo
    A.3.2Name or abbreviated title of the trial where available
    BENEMCOR.es
    BENEMCOR.es
    A.4.1Sponsor's protocol code numberIOBA-04-2012
    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 SponsorIOBA, Universidad de Valladolid
    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 supportIOBA, Universidad de Valladolid
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIOBA, Universidad de Valladolid
    B.5.2Functional name of contact pointMarian Quevedo
    B.5.3 Address:
    B.5.3.1Street AddressCampus Miguel Delibes, Paseo Belen,17
    B.5.3.2Town/ cityValladolid
    B.5.3.3Post code47011
    B.5.3.4CountrySpain
    B.5.4Telephone number34983210 679
    B.5.6E-mailmarian@ioba.med.uva.es
    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® 25 mg/ml
    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.3.1Product nameAvastin® 25 mg/ml
    D.3.2Product code 650602
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    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
    choroidal neovascularization associated to myopia magna
    neovascularización coroidea asociada a la miopía magna
    E.1.1.1Medical condition in easily understood language
    choroidal neovascularization associated to myopia magna
    neovascularización coroidea asociada a la miopía magna
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10060837
    E.1.2Term Choroidal neovascularization
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine whether the use of an intravitreal injection of Bevacizumab (Avastin ®) followed by PRN allows for comparable improvement (not different) in the Best Corrected Visual Acuity against the use of three consecutive monthly injections followed by PRN, as treatment of subfoveal choroidal neovascularization and yuxtafoveolar in pathologic myopia.
    Determinar si el empleo de una inyección intravítrea de Bevacizumab (Avastin®) seguido de PRN permite obtener mejoría comparable (no diferente) en la Mejor Agudeza Visual Corregida frente al empleo de tres inyecciones mensuales consecutivas seguido de PRN, como tratamiento de la neovascularización coroidea subfoveolar y yuxtafoveolar en la miopía patológica.
    E.2.2Secondary objectives of the trial
    1-Determine whether the use of an intravitreal injection of Bevacizumab (Avastin ®) followed by PRN allows a comparable thickening retina decrease (not different) at the fovea against the use of three consecutive monthly injections followed by PRN, as treatment and subfoveal choroidal neovascularization in yuxtafoveolarpathologic myopia.
    2-Determine whether the use of an intravitreal injection of Bevacizumab (Avastin ®) followed by PRN allows a smaller number of injections needed to control the disease versus the use of three consecutive monthly injections followed by PRN, as treatment of subfoveal choroidal neovascularization and yuxtafoveolar in pathologic myopia.
    1-Determinar si el empleo de una inyección intravítrea de Bevacizumab (Avastin®) seguido de PRN permite obtener una disminución comparable (no diferente) del engrosamiento de la retina en la fóvea frente al empleo de tres inyecciones mensuales consecutivas seguido de PRN, como tratamiento de la neovascularización coroidea subfoveolar y yuxtafoveolar en la miopía patológica.
    2-Determinar si el empleo de una inyección intravítrea de Bevacizumab (Avastin®) seguido de PRN permite obtener un menor número de inyecciones necesarias para controlar la enfermedad frente al empleo de tres inyecciones mensuales consecutivas seguido de PRN, como tratamiento de la neovascularización coroidea subfoveolar y yuxtafoveolar en la miopía patológica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Myopic patients over 18 years with active subfoveal choroidal neovascularisation associated to yuxtafoveolar myopia confirmed by AGF and OCT.
    2-Patients with loss of visual acuity less than 6 months lenght caused by the neovascular lesion at the discretion of the researcher.
    3-Lesions in which the presence of atrophic or fibrotic component does not prevent vision improvement .
    4-4-Patients with active subfoveal and yuxtafoveolar choroidal neovascularization associated with myopia magna previously treated with photodynamic therapy.
    5-Informed written consent.
    1-Miopes patológicos mayores de 18 años con neovascularización coroidea activa subfoveolar y yuxtafoveolar asociada a miopía magna confirmado por AGF y OCT.
    2-Pacientes que tengan una pérdida de agudeza visual inferior a 6 meses de evolución y que a criterio del investigador esté causada principalmente por la lesión neovascular.
    3-Lesiones en las cuales la presencia de componente atrófico o fibrótico no impida la mejoría de la visión.
    4-Se permite la inclusión de pacientes con neovascularización coroidea subfoveolar y yuxtafoveolar activa asociada a miopía magna previamente tratados con terapia fotodinámica.
    5-Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1-Previous surgery vitrectomy.
    2-tractional maculopathy and/or idiopathic epiretinal membrane diagnosed by OCT.
    3-media opacity that does not allow to adequately assess the fundus of the eye.
    4-Lack of integrity of the posterior lens capsule in pseudophakia.
    1-Cirugía previa de vitrectomía en el ojo de estudio.
    2-Maculopatía traccional y/o membrana epiretiniana diagnosticada por OCT.
    3-Opacidad de medios que no permita valorar adecuadamente el fondo de ojo.
    4-Falta de integridad de la cápsula posterior del cristalino en pseudofaquia.
    E.5 End points
    E.5.1Primary end point(s)
    1-Best Corrected Visual Acuity: measured by the ETDRS rules with best correction possible.
    1-Mejor Agudeza Visual Corregida: medida según la normativa ETDRS con la mejor corrección posible.
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 30 days
    cada 30 días
    E.5.2Secondary end point(s)
    2-Retinal Thickness: measured by spectral domain OCT
    3-Number of intravitreal injections needed.
    2-Espesor retiniano: medido por OCT de dominio espectral
    3-Número de inyecciones intravítreas necesarias.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Retinal thickness will be evaluated every 30 days.
    Number of injections will be evaluated at the end of the study.
    El espesor retinal será evaluado cada 30 días.
    El número de inyecciones será evaluado al final del estudio.
    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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Inyección simulada
    Simulated Injection
    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 concerned11
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    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 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: 100
    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 state110
    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)
    Patients follow up is the same as normal clinical practice
    El seguimiento de los pacientes será igual a la práctica clínica habitual
    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 Decision2012-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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