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    Summary
    EudraCT Number:2013-002124-17
    Sponsor's Protocol Code Number:IMO-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:2013-08-08
    Trial results View 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 number2013-002124-17
    A.3Full title of the trial
    Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD).
    Ensayo clínico en fase IV para evaluar las variantes genéticas de la vía del VEGF como biomarcadores de eficacia del tratamiento con aflibercept en pacientes con degeneración macular asociada a la edad (DMAE) neovascular.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD).
    Ensayo clínico en fase IV para evaluar las variantes genéticas de la vía del VEGF como biomarcadores de eficacia del tratamiento con aflibercept en pacientes con degeneración macular asociada a la edad (DMAE) neovascular.
    A.3.2Name or abbreviated title of the trial where available
    BIOIMAGE
    BIOIMAGE
    A.4.1Sponsor's protocol code numberIMO-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 SponsorFundació de Recerca de L?Institut de Microcirurgia Ocular
    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 INNAFLIBERCET
    D.3.9.1CAS number AFLIBERCEPT
    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 (VEG-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 genetic variants of VEGF pathway (SNP markers located within the coding and regulatory regions of the genes of the VEGF pathway) and its relation to VEGF trap-Eye treatment efficacy in terms of the percentage of patients with ? 15 letters gain in visual acuity.
    Determinar las variantes genéticas de la vía de VEGF [marcadores de polimorfismo de nucleótido simple (SNP) situados en las regiones codificantes y/o reguladoras de los genes de la vía VEGF] y su relación con la eficacia del tratamiento con aflibercept evaluado según el porcentaje de pacientes con aumento de agudeza visual ? 15 letras.
    E.2.2Secondary objectives of the trial
    Overall and genetic subgroups outcomes in:
    ? Percentage of patients with ?15 letters gain/loss
    ? Mean change in visual acuity (BCVA)at 52 weeks
    ? Mean change in OCT central foveal thickness at 52 weeks
    ? Percentage of patients free of intra or subretinal fluid.
    ? CNV regression/change at week 52 from Baseline
    To assess the safety and tolerability of repeated ITV administration of VEGF Trap-Eye in the whole study population.
    Resultados generales y según subgrupos genéticos en:
    ? Porcentaje de pacientes con ganancia/pérdida ?15 letras a la semana 16 y semana 52.
    ? Cambio medio en la agudeza visual corregida (MAVC) a la semana 16 y semana 52.
    ? Cambio medio en el grosor foveal central mediante OCT a la semana 16 y semana 52.
    ? Porcentaje de pacientes libres de líquido intra o subretiniano a la semana 16 y semana 52.
    ? Regresión/cambio de la neovascularización coroidea (NVC) a la semana 52 respecto visita de selección.
    ? Tiempo de resolución de cualquier fluido intra/subretinal en la OCT respecto visita basal.
    Evaluar la seguridad y tolerabilidad de la administración intravitrea (ITV) repetida cada 8 semanas de aflibercept en la población de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Men and women ? 50 years of age.
    ? Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
    ? ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
    ? Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
    ? Hombres o mujeres con edad igual o superior a 50 años.
    ? Pacientes con lesiones NVC activas subfoveales primarias (secundarias a la DMAE), incluyendo lesiones yuxtafoveales que afecten a la fóvea (confirmado por angiografía) en el ojo de estudio.
    ? Pacientes con una MAVC basal según optotipo ETDRS de 20/40 a 20/320 letras a 4 metros (puntuación entre 73-25 letras) en el ojo de estudio.
    ? Pacientes que estén dispuestos, comprometidos y sean capaces de asistir a todas las consultas y realizar todos los procedimientos relacionados con el estudio.
    ? Pacientes capaces de leer el consentimiento informado (o, en el caso de no poder leer debido a una deficiencia visual, sea leído textualmente por la persona que lo administre o un miembro de la familia), 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
    ? Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD,except dietary supplements or vitamins.
    ? Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
    ? Prior treatment with anti-VEGF therapy in the study eye is not allowed
    ? No inflammation / infection in or around the eye
    ? Known hypersensitivity and allergies.
    ? Ocular surgery in the past other than cataract surgery.
    ? No other ocular disease that could lead to decrease of VA.
    ? Pacientes en tratamiento ocular previo (en el ojo de estudio) o tratamiento sistémico previos para la DMAE neovascular (a excepción de los suplementos alimenticios o vitaminas).
    ? Pacientes con tratamiento previo con terapia anti-VEGF en el ojo de estudio.
    ? Pacientes con cualquier tratamiento previo o concomitante con otro fármaco en investigación para el tratamiento de la DMAE neovascular en el ojo de estudio.
    ? Pacientes con inflamación/infección en o alrededor del ojo de estudio.
    ? Pacientes con cirugía ocular (incluyendo cirugía de cataratas) en el ojo del estudio en los 3 meses anteriores al día 1 del inicio del estudio.
    ? Pacientes con otra/s enfermedad/es ocular/es que pueda conducir a la disminución de la agudeza visual.
    ? Pacientes que no pueden someterse a una angiografía fluoresceínica o fotografía de fondo del ojo debido a alergia a la fluoresceína sódica o hipersensibilidad conocida a la misma.
    E.5 End points
    E.5.1Primary end point(s)
    Genetic variants of VEGF pathway (SNPs alleles) and its correlation with percentage of patients with ?15 letters gain at Week 52.
    Determinar las variantes genéticas de la vía del VEGF (SNPs situados en las regiones codificantes y/o reguladoras de los genes de la vía VEGF) y su correlación con el porcentaje de pacientes que presentan un aumento de agudeza visual ? 15 letras a la semana 52 versus visita basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In week 52
    En semana 52
    E.5.2Secondary end point(s)
    Genetic variants of VEGF pathway (SNPs variants) and its correlation with :
    ? Mean change in BCVA at week 12 measured by ETDRS Scale
    ? Percentage of patients with ?15 letters loss in VA
    ? Percentage of patients with no fluid on OCT at weeks12 and 52.
    ? Time from first injection until no more fluid is seen on OCT
    Safety variables: Ongoing safety assessments will include ophthalmic examinations, the recording and evaluation of clinical AEs.
    Genetic variables: Blood samples will be collected for VEGF pathway genetic variants analysis. Correlations will be studied between the SNPs in the genes of the VEGF pathway and the response to the aflibercept treatment.
    Las variantes genéticas de la vía del VEGF (variantes de tipo SNP) y su correlación con:
    ? El porcentaje de pacientes que presentan una ganancia/pérdida de la agudeza visual ? de 15 letras a la semana 16 y semana 52 versus visita basal.
    ? El cambio medio en la MAVC a la semana 16 y semana 52 según optotipo ETDRS respecto visita basal.
    ? El cambio medio en el grosor foveal central en la OCT a la semana 16 y semana 52 respecto visita basal.
    ? Regresión/cambio de la neovascularización coroidea (NVC) a la semana 52 respecto visita de selección valorado mediante AGF.
    ? El porcentaje de pacientes sin fluido intraretinal/subretinal en OCT a la semana 16 y semana 52 respecto visita basal.
    ? Tiempo de resolución de cualquier líquido intraretinal/subretinal en la OCT respecto visita basal.
    Evaluaciones de seguridad: Acontecimientos adversos y acontecimientos adversos graves (AA y AAGs): Resultados de los exámenes oftalmológicos, Presión intraocular, constantes vitales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Specified above
    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 Yes
    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 concerned25
    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 patient last visit
    La visita del ultimo paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 state194
    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 Decision2013-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
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