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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:2014-000975-21
    Sponsor's Protocol Code Number:RET-AFLI-2014-01
    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:2014-06-09
    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 number2014-000975-21
    A.3Full title of the trial
    A phase IV study to evaluate the effectiveness of aflibercept in naive patients with macular edema secondary to Central Retinal Vein Occlusion (CRVO) on an individualized Treat and Extend regimen. NEUTON study.
    Ensayo clínico en fase IV para evaluar la eficacia de aflibercept en pacientes naïve con edema macular secundario a oclusión de vena central de la retina (OVCR) en régimen de tratamiento individualizado Treat and Extend (TAE). Estudio NEUTON.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the effectiveness of aflibercept in patients with macular edema secondary to central retinal vein occlusion.
    Estudio para evaluar la eficacia de aflibercept en pacientes con edema macular secundario a oclusión de la vena central de la retina.
    A.3.2Name or abbreviated title of the trial where available
    NEUTON
    NEUTON
    A.4.1Sponsor's protocol code numberRET-AFLI-2014-01
    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 SponsorFundación Retinaplus +
    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 pointNoelia Escalona
    B.5.3 Address:
    B.5.3.1Street Addressc/ Consell de Cent, 334 - 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34931850200NA
    B.5.5Fax number+34931850257NA
    B.5.6E-mailnoelia.escalona@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.3.11 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 form 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
    Macular edema secondary to central retinal vein occlusion.
    Edema macular secundario a oclusión de la vena central de la retina.
    E.1.1.1Medical condition in easily understood language
    Macular edema secondary to central retinal vein occlusion.
    Edema macular secundario a oclusión de la vena central de la retina.
    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 evaluate changes in visual acuity during the first year after macular edema secondary to central retinal vein occlusion (CRVO) diagnosis, in terms of mean change in EDTRS visual acuity at 12-months (52 weeks) from baseline.
    Evaluar el cambio medio en la Mejor Agudeza Visual Corregida (MAVC) medida en letras mediante el optotipo ETDRS a los 12 meses (52 semanas) respecto basal durante el primer año del diagnóstico de Edema Macular secundario a Oclusión de Vena Central de la Retina (OVCR), tras la administración de aflibercept en régimen de tratamiento individualizado Treat and Extend (TAE).
    E.2.2Secondary objectives of the trial
    - Proportion of patients gaining 15 or more letters as measured by ETDRS at 52-weeks from baseline
    - Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks.
    - Mean change in foveal thickness on SD-OCT (spectral domain optical coherence tomography) scans at 24 weeks & 52 weeks.
    - Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks.
    - Mean number of intravitreal injections.
    - Percentage of patients only requiring mandatory doses
    - Porcentaje de pacientes con ganancia ? de 15 letras a los 12 meses.
    - Evaluar el cambio medio en la MAVC después de la dosis de carga a las 12 semanas.
    - Cambio medio en el grosor foveal mediante la SD-OCT (tomografía de coherencia óptica de dominio espectral) a la semana 12 y semana 52.
    - Porcentaje de pacientes libres de fluido intra o subretiniano en la SD-OCT a la semana 12 y semana 52.
    - Describir el número medio de inyecciones al final del estudio y su distribución a lo largo del mismo.
    - Porcentaje de pacientes que no requieren inyecciones adicionales (solo obligatorias).
    - Cambio medio de áreas hipofluorescentes sobre AF (Autofluorescencia) a los 12 meses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient ? 50 years old
    - Patient with newly diagnosis macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 6 months with mean central subfield thickness ? 250 ?m on OCT.
    - An ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye.
    - BCVA >20/400 in the fellow eye.
    - Absence of significant cataract that could affect visual results.
    - Able to return for ALL clinic visits and complete all study-related procedures.
    - Absence of other ocular diseases that could affect visual acuity.
    - Willingness to provide written informed consent.
    - Hombres o mujeres con edad igual o superior a 50 años.
    - Paciente con diagnóstico reciente de Edema Macular secundario a Oclusión de Vena Central de la Retina (OVCR), no superior a los 6 meses previos a la inclusión en el estudio, con espesor medio del subcampo central de ? 250 micras en OCT-SD.
    - Pacientes con una puntuación de MAVC basal entre 73 y 24 letras, ambas inclusive, medido mediante el optotipo ETDRS a 4 metros (equivalente al optotipo Snellen de 20/40 y 20/320) en el ojo de estudio.
    - Pacientes con una puntuación de MAVC basal medida con ETDRS a 4 metros de distancia mayor o igual a 20/400 en el optotipo de Snellen (0,05 decimal, 1 línea de visión) en el ojo contralateral.
    - Pacientes con ausencia de cataratas (opacidades) de intensidad suficiente que pudiera afectar a los resultados visuales.
    - Pacientes que estén dispuestos, comprometidos y sean capaces de asistir a todas las consultas y realizar todos los procedimientos relacionados con el estudio.
    - Pacientes que no presenten otras enfermedades oculares que puedan afectar la agudeza visual.
    - 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
    - Previous anti-VEGF therapy, photodynamic therapy or thermal laser in the study eye.
    - Recent cataract surgery (<3 months) in the study eye.
    - Any concurrent ocular disease that could affect the final outcome (diabetic retinopathy, advanced glaucoma, pathologic myopia).
    - No scar, fibrosis, atrophy or hemorrage involving the center of the fovea
    - No RPE rip/tear involving the central fovea
    - Severe proliferative macular ischemia patients and iris rubeosis patients
    - Participation in any other interventional clinical trial
    - History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
    - Active intraocular inflammation in the study eye
    - History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
    ? Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
    - Pacientes en tratamiento previo con terapia anti-VEGF, terapia fotodinámica (TFD) o láser térmico en el ojo de estudio.
    - Pacientes con cirugía intraocular (incluyendo cirugía de cataratas) en el ojo de estudio en los 3 meses previos a la visita basal.
    - Pacientes con cualquier otra/s enfermedad/des ocular/es que pueda conducir a la disminución de la agudeza visual (retinopatía diabética, glaucoma avanzado, miopía patológica).
    - Pacientes con cicatriz, fibrosis o atrofia que afecte el centro de la fóvea en el ojo de estudio.
    - Pacientes con desgarros/roturas en el epitelio pigmentario de la retina (EPR) que afecten el centro de la fóvea en el ojo de estudio.
    - Pacientes con isquemia macular severa proliferativa o con rubeosis del iris.
    - Pacientes con antecedentes de cirugía de vitrectomía, cirugía submacular, u otras cirugías de intervención para la degeneración macular relacionada con la edad (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 incapacidad de cumplir con el estudio y los procedimientos de seguimiento.
    - Pacientes que estén participando de forma simultánea en otro(s) ensayo(s) clínico(s).
    E.5 End points
    E.5.1Primary end point(s)
    Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12-months (52 weeks).
    La evaluación de la variable principal se realizará mediante la determinación del cambio medio de la MAVC medida mediante el optotipo ETDRS a los 12 meses (semana 52) versus visita basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52.
    En semana 52.
    E.5.2Secondary end point(s)
    Proportion of patients gaining 15 or more letters at 12-months measured by ETDRS Scale
    Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks measured by ETDRS Scale.
    Mean foveal thickness change on SD-OCT (spectral domain optical coherence tomography) scans at 12 weeks & 52 weeks.
    Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks.
    Mean number of intravitreal injections.
    Percentage of patients only requiring mandatory doses
    - Porcentaje de pacientes que presentan una ganancia de la MAVC ?15 letras según optotipo ETDRS a los 12 meses respecto visita basal.
    - Cambio medio en la MAVC según optotipo ETDRS después de las dosis de carga (12 semanas) respecto visita basal
    - Cambio medio en el grosor foveal central en la SD-OCT a la semana 12 y semana 52 respecto visita basal.
    - Porcentaje de pacientes sin fluido intra/subretiniano en la SD-OCT a la semana 12 y semana 52 respecto visita basal.
    - Promedio de inyecciones intravítreas.
    - Porcentaje de pacientes que no requieren inyecciones adicionales (solo las obligatorias).
    - Cambio medio de áreas hipofluorescentes sobre AF a los 12 meses respecto visita basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Specified above.
    Según se especifica 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.8.3 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 concerned15
    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
    Última visita del último 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 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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state50
    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)
    None
    Ninguno
    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 Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
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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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