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    Summary
    EudraCT Number:2013-000848-26
    Sponsor's Protocol Code Number:BMF-AFLI-2013-01
    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:2013-06-11
    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 number2013-000848-26
    A.3Full title of the trial
    Phase IV study to evaluate the efficacy of aflibercept in subjects with neovascular age-related macular degeneration (wAMD), without optimal response to repeated monthly intravitreal injections of anti VEGF-A therapy.
    Ensayo clínico en fase IV para evaluar la eficacia de aflibercept en pacientes con degeneración macular asociada a la edad (DMAE) neovascular, sin respuesta óptima a repetidas inyecciones mensuales intravitreas de anti VEGF-A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IV study to evaluate the efficacy of aflibercept in subjects with neovascular age-related macular degeneration (wAMD), without optimal response to repeated monthly intravitreal injections of anti VEGF-A therapy.
    Ensayo clínico en fase IV para evaluar la eficacia de aflibercept en pacientes con degeneración macular asociada a la edad (DMAE) neovascular, sin respuesta óptima a repetidas inyecciones mensuales intravitreas de anti VEGF-A.
    A.3.2Name or abbreviated title of the trial where available
    MACBETH
    MACBETH
    A.4.1Sponsor's protocol code numberBMF-AFLI-2013-01
    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 SponsorBarcelona Macula Foundation
    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 supportBAYER
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support
    B.5.2Functional name of contact pointElisabet Molina
    B.5.3 Address:
    B.5.3.1Street AddressC/ Consell de Cent, 334 4 planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34931850200
    B.5.5Fax number+34931850257
    B.5.6E-mailelisabet.molina@tfscro.com
    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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameEylea
    D.3.2Product code Eylea
    D.3.4Pharmaceutical form Solution for injection
    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 INNAFLIBERCEPT
    D.3.9.2Current sponsor codeAFLIBERCEPT
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeAflibercept (VEGF-Trap-Eye) is a fusion protein with high VEGF affinity attributed to binding sequences from the native receptors VEGFR1 and VEGFR2.
    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
    Wet age-related macular degeneration
    Degeneración macular asociada a la edad (DMAE) neovascular
    E.1.1.1Medical condition in easily understood language
    Wet age-related macular degeneration
    Degeneración macular asociada a la edad (DMAE) neovascular
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    To study the efficacy of aflibercept treatment of wAMD patients without optimal response to anti VEGF-A therapy, in terms of the percentage of patients with no fluid on OCT after loading dose (intra or subretinal) of aflibercept (3 initial monthly doses).
    Evaluar la eficacia del tratamiento con aflibercept en pacientes con DMAE neovascular sin respuesta óptima al tratamiento con anti VEGF-A mediante la determinación del porcentage de pacientes que no presentan fluido en la OCT después de la dosis de carga de aflibercept (3 dosis iniciales mensuales).
    E.2.2Secondary objectives of the trial
    - Mean change in visual acuity (BCVA) after loading dose at 12 weeks
    - Mean change in OCT central foveal thickness after loading dose at 12 weeks
    - Anatomic outcomes maintained during the treatment (administrated every 8 weeks) at week 40, in central retinal thickness and VA outcomes maintained during the treatment (administrated every 8 weeks) at week 40, in terms of BCVA.
    - Time to resolution of any intra/subretinal fluid on OCT
    - Describe safety of aflibercept in this studied population according to ocular and non-ocular adverse events (AE), characterized by: type, frequency, relation and severity, during the 40 weeks.
    - Evaluar el cambio medio en la MAVC después de la dosis de carga a las 12 semanas.
    - Evaluar el cambio medio en el grosor foveal central mediante OCT después de la dosis de carga a las 12 semanas.
    - Evaluar el mantenimiento de los resultados anatómicos y de AV durante el tratamiento administrado cada 8 semanas en la visita a la semana 40 mediante la valoración de la MAVC y el grosor foveal central.
    - Determinar el tiempo de resolución de cualquier fluido intraretinal/subretinal en la OCT.
    - Evaluar la seguridad de aflibercept mediante la determinación de los acontecimientos adversos (AA) oculares y no oculares caracterizados según: tipo, frecuencia, relación y gravedad, durante las 40 semanas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women ? 50 years of age.
    - Patients with any CNVM lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
    - Patients with ETDRS best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
    - Patients able to return for ALL clinic visits and complete all study-related procedures.
    - Patients with absence of other ocular diseases that could affect visual acuity.
    - Patients without optimal response to ranibizumab or bevacizumab defined as:
    - Patient with significant persistent or recurrent fluid (intraretinal or ubretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 5 (+/- 1 week) after last treatment with ranibizumab or bevacizumab.
    - Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three montly treatment with ranibizumab or bevacizumab.
    - Patients who give their signed Informed Consent before any assessment and who expressly consent to the inclusion of their data in the medical history and those resulting from participation in the study in a file of personal data under the responsibility of the Centre.
    - Hombres o mujeres con edad igual o superior a 50 años.
    - Pacientes con lesión en la membrana neovascular coroidea (MNVC) (oculta, minimamente clásica o clásica) secundaria a la DMAE.
    - Pacientes con una MAVC basal según optotipo ETDRS entre 20/32-20/320 letras (puntuación entre 73-25 letras) en el ojo de estudio.
    - Pacientes capaces de realizar todas las visitas del estudio y de completar todos los procedimentos del estudio.
    - Pacientes que no presenten otras enfermedades oculares que puedan afectar la agudeza visual.
    - Pacientes sin respuesta óptima a los tratamientos con ranibizumab o bevacizumab definidos como:
    - Pacientes con fluido persistente o recurrente significativo (intraretinal o subretinal) en la OCT o con cualquier fuga observada en la angiografía fluoresceínica a pesar de haber recibido un mínimo de 4 inyecciones en los últimos 6 meses, mostrando fluido en la última OCT realizada en las 5 (+/- 1 semana) semanas después del último tratamiento con ranibizumab o bevacizumab.
    - Pacientes con fluido persistente o recurrente significativo (intraretinal o subretinal) en la OCT o cualquier fuga observada en la angiografía fluoresceínica a pesar de haber recibido tratamiento mensual durante 3 meses con ranibizumab o bevacizumab.
    - Pacientes que otorguen su consentimiento firmado antes de proceder a cualquier evaluación y consientan expresamente la inclusión de los datos de su historia clínica así como los resultantes de la participación en el estudio en un fichero de datos personales bajo la responsabilidad del Centro.
    E.4Principal exclusion criteria
    - Patients without scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
    - Patients without RPE rip/tear involving the central fovea in the study eye.
    - Patients with prior treatment with PDT
    - Patients with prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
    - Patients with intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
    - Patients with history of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
    - Patients with active intraocular inflammation in the study eye
    - Patients with history of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
    - Patients unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
    - Potentially women who plan to become pregnant, are pregnant and / or breastfeeding, or who do not wish to use effective contraception (hormonal contraceptives [implementation, patches, oral], and double barrier methods [any double combination: IUDs, male or female prophylactics with spermicidal jelly, diaphragm, contraceptive sponge, cervical cap]).
    - Patients who are participating in another simultaneous interventional clinical trial
    - Pacientes con cicatriz, fibrosis o atrofia que afecte el centro de la fóvea en el ojo de estudio.
    - Pacientes con desgarros/roturas en el EPR que afecten el centro de la fóvea en el ojo de estudio.
    - Pacientes con tratamiento previo con PDT.
    - Pacientes con tratamiento previo con anti-VEGF o esteorides en el ojo de estudio en los 28 días previos a la visita basal.
    - Pacientes con cirugía intraocular (incluyendo cirugía de cataratas) en el ojo de studio en los 2 meses previos a la visita basal.
    - Pacientes con antecedentes de cirugía de vitrectomía, cirugía submacular, u otras cirugías de intervención para la DMAE en el ojo de estudio.
    - Pacientes con inflamación intraocular activa en el ojo de estudio.
    - Pacientes con antecedentes de accidente cerebrovascular, infarto de miocardio o ataques isquémicos transitorios en los 3 meses previos al inicio del estudio.
    - Pacientes que no pueden someterse a una angiografía fluoresceínica o fotografía de fondo del ojo debido a alergias no controladas.
    - Mujeres potencialmente fértiles que tengan previsto quedarse embarazadas, estén embarazadas y/o en periodo de lactancia, o bien que no deseen utilizar un método anticonceptivo eficaz (anticonceptivos hormonales [implantación, parches, oral], y métodos de doble barrera [cualquier combinación doble de: DIU, profilácticos masculinos o femeninos con gel espermicida, diafragma, esponja anticonceptiva, capuchón cervical]).
    - Pacientes con RAP (angiomatosis retiniana proliferante) o vasculopatía coroidea polipoidal idiopática (VCPI).
    - Pacientes que estén participando de forma simultánea en otros ensayos clínicos.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with no fluid on OCT after 3 loading doses of VEGF Trap-Eye (week 12).
    La variable principal de eficacia será la determinación del porcentage de pacientes que no presentan fluido en la OCT después de las tres dosis de carga mensuales de aflibercept (semana 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    In week 12 after 3 loading doses of VEGF Trap-Eye.
    En semana 12 después de la dosis de carga de alfibercept.
    E.5.2Secondary end point(s)
    - Mean change in BCVA at week 12 measured by ETDRS Scale
    - Percentage of patients with no fluid on OCT at week 40.
    - Mean change in BCVA at week 40 measured by ETDRS Scale
    - Time to no fluid on OCT
    - Cambio medio en la MAVC según optotipo ETDRS después de las dosis de carga (semana 12) respecto visita basal.
    - Cambio medio en el grosor foveal central según OCT después de las dosis de carga (semana 12) respecto visita basal.
    - Porcentage de pacientes que no presentan fluido en la OCT en la semana 40 respecto visita basal.
    - Cambio medio en la MAVC según optotipo ETDRS en la semana 40 respecto visita basal.
    - Tiempo de resolución de cualquier fluido intraretinal/subretinal en la OCT respecto visita basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and week 40 depending of the end point. Specified above
    Semana 12 y semana 40 dependiendo de la variable. Especificado arriba
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned9
    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
    Last patien last visit
    Última vistia del último paciente
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state43
    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)
    NA for this trial
    No aplica para este estudio
    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 Decision2013-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
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