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    Summary
    EudraCT Number:2013-000120-33
    Sponsor's Protocol Code Number:BAY86-5321/16598
    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:2015-07-10
    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 number2013-000120-33
    A.3Full title of the trial
    An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of 2 mg aflibercept administered by intravitreal injections using two different treatment regimens to subjects with neovascular age-related macular degeneration (nAMD).
    Estudio de fase IIIb abierto, aleatorizado, controlado con fármaco activo y con grupos paralelos para evaluar la eficacia, la seguridad y la tolerabilidad de 2 mg de aflibercept administrados mediante inyección intravítrea utilizando dos regímenes terapéuticos distintos a sujetos con degeneración macular neovascular asociada a la edad (DMAE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of two different aflibercept regimens in subjects with nAMD.
    Eficacia y seguridad de dos pautas terapéuticas diferentes de aflibercept en pacientes con DMAE exudativa
    A.3.2Name or abbreviated title of the trial where available
    AZURE
    A.4.1Sponsor's protocol code numberBAY86-5321/16598
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref: 'EU CTR' / Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 40mg/ml solution for injection in a vial
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAflibercept
    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.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeBAY 86-5321
    D.3.9.3Other descriptive nameVEGF Trap-Eye / AFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    Neovascular Age-Related Macular Degeneration (nAMD)
    degeneración macular neovascular asociada a la edad (DMAE)
    E.1.1.1Medical condition in easily understood language
    Neovascular age-related macular edema (nAMD) is a medical condition that affects older adults and results in a loss of vision in the center of the visual field because of damage to the retina.
    La degeneración macular asociada a la edad (DMAE) afecta a la población en edad madura y comporta pérdida de visión en el campo central debido a daños en la retina
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    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
    To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with nAMD.
    Comparar la eficacia de la administración de 2 mg de aflibercept mediante inyección intravítrea en dos pautas terapéuticas diferentes en sujetos con DMAE exudativa
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of aflibercept in this subject population.
    Evaluar la seguridad y la tolerabilidad de aflibercept en esta población de sujetos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    First set of inclusion criteria:
    All of the following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment before this study):
    - Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by FA/FP of the study eye within 3 weeks before the initiation of aflibercept treatment.
    - The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
    - Documented BCVA was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment. Because BCVA may not have been assessed by the ETDRS protocol at initiation of aflibercept treatment, guidance for conversion of data, (e.g. Snellen to approximate ETDRS) will be provided in the study manual.
    Second set of inclusion criteria:
    All of the following criteria must be met at the time of screening include the following (incomplete list):
    - Men and women >= 51 years of age
    - The subject's history of aflibercept treatment meets ALL of the following:
    a) Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
    b) Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks (one exception will be allowed)
    c) The interval between the last two pre-study injections was >= 8 weeks, and visual and anatomic outcomes have been stable over this interval.
    d) The subject received the last IVT injection of aflibercept in the study eye >= 2 months (±10 days) before the first treatment in this study
    e) Total prior treatment duration with aflibercept (i.e. from first treatment to randomization into this study) was >= 12 months
    - Subject is willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
    - Women and men of reproductive potential must agree to utilize two reliable and acceptable methods of contraception simultaneously when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.
    Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
    Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
    PRIMER GRUPO de criterios de inclusión:
    Deben cumplirse los siguientes criterios al inicio del primer tratamiento con aflibercept (es decir, el inicio del tratamiento con aflibercept antes de este estudio):
    - Sujetos con lesiones de neovascularización coroidea subfoveal (NVC) causadas por DMAE exudativa, incluidas las lesiones yuxtafoveales que afectan la fóvea, observadas en la angiografía con fluoresceína (AGF) o en la retinografía del ojo en estudio en un plazo de 3 semanas antes del inicio del tratamiento con aflibercept.
    - Área con NVC de al menos el 50 % de la lesión total en el plazo de 3 semanas antes del inicio del tratamiento con aflibercept.
    - Mejor agudeza visual corregida (MAVC) documentada del ojo en estudio de entre 20/40 y 20/320 (entre 73 y 25 letras) al inicio del tratamiento. Puesto que es posible que la MAVC no fuera evaluada empleando el protocolo del estudio sobre el tratamiento precoz de la retinopatía diabética (Early Treatment Diabetic Retinopathy Study, ETDRS), en el manual de estudio se proporcionarán instrucciones para la conversión de las evaluaciones de agudeza visual de Snellen.

    SEGUNDO GRUPO de criterios de inclusión:
    Entre los criterios que han de cumplirse en el momento de selección, cabe destacar los siguientes (la lista no es exhaustiva):
    - Ser hombre o mujer y tener >=51 años.
    - El tratamiento previo con aflibercept del sujeto deberá cumplir TODOS los criterios siguientes:
    a) Tratamiento del ojo en estudio iniciado con tres administraciones mensuales (-1 semana/+2 semanas) de 2 mg de aflibercept con mejoras en los resultados visuales y anatómicos.
    b) Tras la fase de inicio del tratamiento indicada anteriormente, intervalos de administración de entre 6 y 12 semanas (se permite una excepción).
    c) Intervalo entre las dos últimas inyecciones previas al inicio del estudio >= 8 semanas con resultados visuales y anatómicos estables en dicho periodo.
    d) Última inyección intravítrea de aflibercept en el ojo en estudio >= 2 meses (±10 días) antes de la primera administración de la primera dosis en el marco de este estudio.
    e) Duración total de tratamiento con aflibercept antes del inicio del estudio (es decir, desde el primer tratamiento hasta la aleatorización para este estudio) >= 12 meses.
    El sujeto muestra su voluntad, compromiso y disponibilidad para acudir al centro para TODAS las visitas y someterse a todas las pruebas relacionadas con el estudio.
    8. Las mujeres y hombres fértiles deberán comprometerse a usar dos métodos anticonceptivos fiables y aceptables de forma simultánea cuando mantengan relaciones sexuales. Esto se aplica al periodo de tiempo comprendido entre la firma del consentimiento informado y los 3 meses posteriores a la última administración del fármaco en estudio.
    Los métodos anticonceptivos aceptables son, entre otros, (i) preservativo (masculino y femenino) con o sin espermicida; (ii) diafragma o capuchón cervical con espermicida; (iii) dispositivo intrauterino (DIU); (iv) anticonceptivos hormonales.
    Para que se consideren que no son fértiles, las mujeres posmenopáusicas no deberán haber menstruado durante al menos 12 meses.
    E.4Principal exclusion criteria
    First set of exclusion criteria:
    A subject who has met any of the following criteria at the initial start of aflibercept treatment (i.e. start of aflibercept treatment before this study) will be excluded from this study.
    - Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye.
    - Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye
    - Subretinal hemorrhage that was:
    a) 50% or more of the total lesion area, or
    b) if the blood was under the fovea, and
    c) the blood under the fovea was 1 or more disc areas in size in the study eye.
    - Scar or fibrosis making up more than 50% of the total lesion in the study eye.
    - Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
    - Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
    - Causes of CNV other than AMD in the study eye.
    Second set of exclusion criteria:
    Criteria leading to exclusion if met at the time of screening include the following (incomplete list):
    - Subjects who currently meet any of the first set of exclusion criteria with the exception of prior treatment with aflibercept
    - Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements, vitamins and IVT injections of aflibercept, during the time (i.e. at least 12 months) between initiation of aflibercept treatment and randomization into this study
    - Any prior treatment with anti-VEGF therapy in the study eye, with the exception of IVT injections of aflibercept, during the time (i.e. at least 12 months) between initiation of aflibercept treatment and randomization into this study
    - Prior systemic anti-VEGF therapy, investigational or approved, within the last 15 months prior to randomization
    - Any vitreous hemorrhage within 4 weeks before randomization
    - Active intraocular, extraocular and periocular inflammation or infection in either eye.
    - Any ocular or periocular infection within 4 weeks of randomization
    - Any serious adverse event related to aflibercept during prior treatment
    - Any history of allergy to povidone iodine.
    - Known serious allergy to the fluorescein sodium for injection in angiography
    - Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept: Hypersensitivity to the active substance aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation
    - Prior vitrectomy in the study eye
    - History of vitreomacular traction
    - History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
    - Any history of macular hole of stage 2 and above in the study eye
    - Prior trabeculectomy or other filtration surgery in the study eye
    - Uncontrolled glaucoma (defined as intraocular pressure more than 25 mmHg despite treatment with antiglaucoma medication) in the study eye
    - Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of an yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye
    - Previous therapeutic radiation in the region of the study eye
    - History of corneal transplant or corneal dystrophy in the study eye
    - Significant media opacities, including cataract, in the study eye that interferes with visual acuity or fundus photography
    - History or clinical evidence of DME or any retinal vascular disease other than AMD in either eye
    - Any history of uveitis in either eye
    - Presence of scleromalacia in either eye
    - Pregnancy or breast-feeding (women only)
    - The use of long acting steroids, either systemically or intraocular, in the 18 months before initiating study treatment
    - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications
    - Previous assignment to treatment during this study
    - Concomitant participation in another clinical study with investigational medicinal product(s)
    - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site).
    PRIMER GRUPO de criterios de exclusión:
    Se excluirá de este estudio a cualquier sujeto que cumpla alguno de los siguientes criterios al inicio del primer tratamiento con aflibercept (es decir, el primer tratamiento con aflibercept antes de este estudio).
    1. Cualquier tratamiento previo y concomitante con un fármaco en estudio o autorizado para el tratamiento de la DMAE exudativa del ojo en estudio.
    2. Tamaño total de la lesión >12 áreas de disco (30,5 mm2, incluidas la sangre, las cicatrices y la neovascularización) observada en la AGF del ojo en estudio.
    3. Que se observe una hemorragia subretiniana
    a) equivalente al menos al 50 % del área total de la lesión o
    b) en caso de sangre subfoveal,
    c) que ocupe una o más áreas de disco en el ojo en estudio.
    4. Que la cicatriz o la fibrosis constituya más del 50 % del total de la lesión del ojo en estudio.
    5. Cicatriz, fibrosis o atrofia que comprometa el centro de la fóvea del ojo en estudio.
    6. Desgarro o desprendimiento del epitelio pigmentario retiniano que afecte la mácula del ojo en estudio.
    7. Causas de la neovascularización coroidea (NVC) distintas de la DMAE en el ojo en estudio.

    SEGUNDO GRUPO de criterios de exclusión:
    Se excluirá del estudio a aquellos sujetos que cumplan cualquiera de los siguientes criterios en el momento de la selección:
    8. Sujetos que cumplan alguno de los criterios incluidos en el primer grupo de criterios de exclusión, salvo el tratamiento previo con aflibercept.
    9. Cualquier tratamiento oftálmico (en el ojo en estudio) o generalizado o intervención quirúrgica para tratar la DMAE exudativa, a excepción de los suplementos nutricionales y vitamínicos, o el tratamiento con inyecciones intravítreas de aflibercept durante el periodo comprendido entre el inicio del tratamiento con aflibercept y la aleatorización en este estudio (al menos 12 meses).
    10. Cualquier tratamiento previo con fármacos anti-VEGF en el ojo en estudio, a excepción del tratamiento con inyecciones intravítreas de aflibercept durante el periodo comprendido entre el inicio del tratamiento con aflibercept y la aleatorización en este estudio (al menos 12 meses).
    11. Tratamiento previo y generalizado con fármacos anti-VEGF, en estudio o autorizados, en un plazo de 15 meses antes de la aleatorización.
    12. Hemorragia vítrea en un plazo de 4 semanas antes de la aleatorización.
    13. Inflamación intraocular, extraocular o periocular o infección en curso en cualquiera de los dos ojos.
    14. Infecciones oculares o perioculares en un plazo de 4 semanas antes de la aleatorización.
    15. Acontecimientos adversos relacionados con aflibercept durante el tratamiento previo (véanse los apartados 9.6.1.1 y 9.6.1.2).
    16. Antecedentes de alergia a la povidona yodada.
    17. Alergia grave conocida a la fluoresceína sódica inyectable necesaria para efectuar la angiografía.
    18. Presencia de alguna de las contraindicaciones recogidas en la ficha técnica de aflibercept autorizada por la UE/el país correspondiente: Hipersensibilidad al principio activo aflibercept o a alguno de los excipientes; infección ocular o periocular activa o presunta; inflamación intraocular activa grave.
    19. Vitrectomía previa en el ojo en estudio.
    20. Antecedentes de tracción vitreomacular.
    21. Antecedentes de desprendimiento de retina o tratamiento o intervención quirúrgica por desprendimiento de retina en el ojo en estudio.
    22. Antecedentes de agujero macular de estadio 2 o superior en el ojo en estudio.
    23. Antecedentes de trabeculectomía u otra intervención quirúrgica de filtración en el ojo en estudio.
    24. Glaucoma no estabilizado (definido por una presión intraocular superior a los 25 mmHg a pesar del tratamiento con fármacos antiglaucomatosos) en el ojo en estudio.
    25. Afaquia o pseudofaquia con ausencia de la cápsula posterior (a menos que esto se deba a la capsulotomía posterior con láser YAG) en el ojo en estudio.
    26. Tratamiento previo con radioterapia en la región del ojo en estudio.
    27. Antecedentes de trasplante de cornea o distrofia corneal en el ojo en estudio.
    28. Opacidad significativa del medio ocular, como catarata en el ojo en estudio que interfiera en la agudeza visual o la retinografía.
    29. Antecedentes o signos clínicos de edema macular diabético (EMD) o de cualquier otra enfermedad vascular de la retina distinta a la DMAE en cualquiera de los dos ojos.
    30. Antecedentes de uveítis en cualquiera de los dos ojos.
    31. Presencia de escleromalacia en cualquiera de los dos ojos.
    32. Embarazo o lactancia (solo para las mujeres).
    33. Consumo de esteroides de larga duración, sean generalizados o intraoculares, en los 18 meses previos al inicio del tratamiento en estudio.
    (consultar resto de criterios en protocolo)
    E.5 End points
    E.5.1Primary end point(s)
    Change in ETDRS BCVA letter score for the study eye from baseline
    to Week 52.
    Cambio en la MAVC del ojo en estudio en la semana 52 con respecto al valor basal, determinada por la puntuación de letras del ETDRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    Efficacy assessments:
    - Proportion of subjects maintaining vision (i.e. loss of < 15 letters) in
    the study eye at Week 52
    - Proportion of subjects who gained >= 5 letters from baseline to
    Week 52
    - Mean change in central retinal thickness (CRT) in the study eye from
    baseline to Week 52
    - Mean change in CNV area in the study eye from baseline to Week 52
    - Proportion of subjects who lost >= 30 letters from baseline to Week 52
    - Mean change from baseline to Week 52 in total score for NEI VFQ-25
    - Proporción de sujetos que mantienen la visión del ojo en estudio (pérdida <15 letras) en la semana 52.
    - Proporción de sujetos que ganen >= 5 letras de visión en la semana 52 en comparación con el valor basal.
    - Cambio medio en el grosor retiniano central (GRC) del ojo en estudio en la semana 52 en comparación con el valor basal.
    - Cambio medio en el área de la NVC del ojo en estudio en la semana 52 en comparación con el valor basal.
    - Proporción de sujetos que pierdan >= 30 letras de visión en la semana 52 en comparación con el valor basal.
    - Cambio medio en la puntuación total del cuestionario
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 52.
    visita inicial y semana 52
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Aflibercept
    Aflibercept
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Lithuania
    Poland
    Portugal
    Slovakia
    Spain
    Switzerland
    United Kingdom
    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
    For each participating EU country, the end of the study according to the EU Clinical Trial Directive will be reached when the last visit of the last subject for all centers in the respective country has occurred.
    The end of the study as a whole will be reached as soon as the end of the study according to the above definition has been reached in all participating countries (EU and non-EU).
    Para los participantes de la UE, el final del estudio tendrá lugar cuando el último paciente tenga la última visita en todos los centros de ese país.
    El final del estudio global será cuando lo anterior se cumpla en todos los países (dentro y fuera de la UE)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 245
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 305
    F.4.2.2In the whole clinical trial 330
    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)
    After Week76 (completion of trial), subjects should be returned to standard of care.
    Tras la semana 76 (final de ensayo), los pacientes volverán a su tratamiento médico 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 Decision2015-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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