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    EudraCT Number:2014-005119-17
    Sponsor's Protocol Code Number:BAY86-5321/17850
    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:2015-05-08
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-005119-17
    A.3Full title of the trial
    Open-label Phase-4 study to examine the change of vision-related quality of life in subjects with diabetic macular edema (DME) during treatment with intravitreal injections of 2 mg aflibercept according to EU label for the first year of treatment.
    Estudio abierto de fase IV para evaluar el cambio en la calidad de vida relacionada con la visión en sujetos con edema macular diabético (EMD) durante el tratamiento con inyecciones intravítreas de 2 mg de aflibercept con arreglo a la ficha técnica para la UE durante el primer año de tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of EU-label-treatment with aflibercept on vision-related quality of life and safety in subjects with diabetic macular edema.
    Impacto del tratamiento con aflibercept según la ficha técnica de la UE en la calidad de vida relacionada con la visión y la seguridad en sujetos con EMD.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBAY86-5321/17850
    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.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.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
    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. name Eylea 40mg/ml solution for injection in a vial
    D. 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Diabetic macular edema (DME)
    Edema macular diabético (EMD)
    E.1.1.1Medical condition in easily understood language
    Diabetic macular edema (DME) is a manifestation of Diabetic Retinopathy - damage to the blood vessels of the retina caused by complications of diabetes.
    El edema macular diabético (EMD) es una manifestación de la retinopatía diabética, una lesión en los vasos sanguíneos de la retina debida a la complicación de la diabetes.
    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 LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    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 evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU label for DME
    Evaluar el cambio en la calidad de vida (NEI VFQ 25) en sujetos con EMD durante el primer año de tratamiento con aflibercept conforme a la ficha técnica de la UE
    E.2.2Secondary objectives of the trial
    - To assess further the safety and tolerability of aflibercept in this population
    - To assess the change in the diabetic retinopathy severity score (DRSS) from baseline to Week 52
    - To support patient recruitment for the EMA-requested post-approval efficacy study in DME
    - Evaluar con mayor profundidad la seguridad y tolerabilidad de aflibercept en esta población
    - Evaluar el cambio en la puntuación de la gravedad de la retinopatía diabética (DRSS) desde el inicio del estudio hasta la semana 52
    - Facilitar el reclutamiento de pacientes para el estudio de la eficacia en el EMD posterior a la aprobación solicitado por la EMA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults of either sex, >=18 years of age
    2. Willingness and ability to comply with clinic visits and study-related procedures
    3. Women and men of reproductive potential must agree to use adequate contraception 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.
    The definition of adequate contraception will be based on the judgment of the investigator and on local requirements.
    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.
    Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously.
    Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
    4. Negative pregnancy test (urine or serum; women of childbearing potential only)
    5. Written informed consent
    6. Type 1 or 2 diabetes mellitus
    7. Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
    8. Decrease in vision determined to be primarily the result of DME in the study eye
    9. BCVA in the study eye of ETDRS letter score 73 to 24
    (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320)
    1. Adultos de ambos sexos, edad >=18 años.
    2. Disposición y capacidad de cumplir con las visitas clínicas y los procedimientos del estudio.
    3. Las mujeres y los hombres fértiles que sean sexualmente activos deben acceder a usar un método anticonceptivo adecuado. Esto se aplica al período de tiempo situado entre la firma del formulario de consentimiento informado y 3 meses después de la última administración de fármaco del estudio.
    La definición de método anticonceptivo adecuado se basará en el criterio del investigador y en las disposiciones locales.
    Son métodos anticonceptivos aceptables, entre otros, (i) los preservativos (masculinos o femeninos) con o sin espermicida; (ii) el diafragma o el capuchón cervical con espermicida; (iii) el dispositivo intrauterino; (iv) los anticonceptivos hormonales.
    Los sujetos deben acceder a utilizar dos métodos anticonceptivos fiables y aceptables de manera simultánea.
    Las mujeres posmenopáusicas deben haber sido amenorreicas durante al menos 12 meses para no ser consideradas fértiles.
    4.Prueba de embarazo negativa (orina o suero; mujeres fértiles únicamente).
    5.Consentimiento informado por escrito.
    6.Diabetes mellitus de tipo 1 o 2.
    7.Diagnóstico de EMD secundario a diabetes mellitus que afecta al centro de la mácula (definido como la región del subcampo central en la TCO) en el ojo de estudio.
    8.Descenso de la visión que se ha determinado que se debe principalmente al EMD en el ojo de estudio.
    9.MAVC en el ojo de estudio de la puntuación en las letras del ETDRS de 73 a 24.
    (Esto corresponde a un equivalente de Snellen de aproximadamente entre 20/40 y 20/320).
    E.4Principal exclusion criteria
    1. Previous treatment with anti-angiogenic drugs in study eye (e.g. pegaptanib sodium, bevacizumab, ranibizumab) within the last 12 weeks
    2. History of vitreoretinal surgery and/or including scleral buckling in the study eye
    3. Use of long acting steroids, either periocular or intraocular, in the preceding 120 days
    4. Any ocular or periocular infection in the preceding 4 weeks
    5. Active proliferative diabetic retinopathy (PDR), current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
    6. Aphakia in the study eye
    7. Cataract surgery within 90 days
    8. Yttrium-aluminum-garnet capsulotomy in the study eye within 30 days
    9. Any other intraocular surgery within 90 days
    10. Ocular inflammation (including trace or above) or history of uveitis in the study eye
    11. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
    12. Pre-retinal fibrosis involving the macula of the study eye
    13. Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
    14. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
    15. Intraocular pressure (IOP) ? 25 mmHg in the study eye
    16. Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
    17. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ? 8 diopters
    18. Administration of systemic anti angiogenic agents within 180 days
    19. Uncontrolled diabetes mellitus in the opinion of the investigator
    20. Uncontrolled blood pressure (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg while subject is sitting confirmed in two separate measurements)
    21. Presence of any contraindications indicated in the EU commission/locally approved label for aflibercept
    22. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
    23. Allergy to fluorescein
    24. Current treatment for a serious systemic infection
    25. History of either cerebral vascular accident and/or myocardial infarction within 180 days
    26. Renal failure requiring dialysis or renal transplant
    27. 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
    28. Significant media opacities, including cataract, in the study eye that interferes with visual acuity, fundus photography or OCT imaging.
    29. Breast-feeding women
    30. Previous assignment to treatment during this study
    31. Concomitant participation in another clinical study with investigational medicinal product(s).
    32. 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)
    1. Tratamiento previo con fármacos antiangiogénicos en el ojo de estudio (p. ej., pegaptanib de sodio, bevacizumab, ranibizumab) en las últimas 12 semanas.
    2. Antecedentes de operación quirúrgica vitreorretiniana o cerclaje escleral en el ojo de estudio.
    3. Uso de esteroides de acción prolongada, perioculares o intraoculares, en los 120 días precedentes.
    4. Toda infección ocular o periocular en las 4 semanas previas.
    5. Retinopatía diabética proliferativa (RDP) activa, neovascularización del iris actual, hemorragia vítrea o desprendimiento de retina traccional en el ojo de estudio.
    6. Afaquia en el ojo de estudio.
    7. Operación de cataratas en los 90 días previos.
    8. Capsulotomía con láser itrio-aluminio-granate en el ojo de estudio en los 30 días previos.
    9. Cualquier otra operación quirúrgica en los 90 días previos.
    10. Inflamación ocular (incluidos indicios o más) o antecedentes de uveítis en el ojo de estudio.
    11. Tracción vitreomacular o membrana epirretiniana en el ojo de estudio evidente biomicroscópicamente o en la TCO que se cree que afecta a la visión central.
    12. Fibrosis prerretiniana que afecta a la mácula del ojo de estudio.
    13. Daño estructural en el centro de la mácula en el ojo de estudio que probablemente impida las mejoras de la MAVC tras la resolución del edema macular, incluidos atrofia del epitelio del pigmento retiniano, fibrosis o cicatrices subretinianas, isquemia macular significativa o exudados duros organizados.
    14. Operación de filtración para glaucoma en el pasado o que probablemente sea necesaria en el futuro en el ojo de estudio.
    15. Presión intraocular (PIO) ?25 mmHg en el ojo de estudio.
    16. Enfermedad concomitante en el ojo de estudio, distinta del EMD, que pusiera en peligro la AV, requiriera una intervención médica o quirúrgica durante el estudio o pudiera confundir la interpretación de los resultados (incluidos oclusión vascular retiniana, desprendimiento de retina, agujero macular o neovascularización coroidal de cualquier etiología).
    17. Miopía de un equivalente esférico previa a cualquier operación posible refractiva o de cataratas de ?8 dioptrías.
    18. Administración de fármacos antiangiogénicos sistémicos en los últimos 180 días.
    19. Diabetes mellitus no controlada, en opinión del investigador.
    20. Presión arterial no controlada (definida como presión arterial sistólica >160 mmHg o presión arterial diastólica >95 mmHg con el sujeto en sedestación confirmada en dos mediciones separadas).
    21. Presencia de cualquier contraindicación mencionada en la ficha técnica aprobada por la Comisión Europea o localmente del aflibercept.
    22. Signos de blefaritis infecciosa, queratitis, escleritis o conjuntivitis en cualquiera de los dos ojos.
    23. Alergia a la fluoresceína.
    24. Tratamiento actual para una infección sistémica grave.
    25. Antecedentes de accidente cerebrovascular o infarto de miocardio en los 180 días previos.
    26. Insuficiencia renal que requiere diálisis o trasplante renal.
    27. Antecedentes de otra enfermedad, disfunción metabólica, hallazgo de la exploración física o resultado de los análisis clínicos que lleven a sospechar razonablemente de una enfermedad o afección que contraindique el uso de un fármaco en investigación, que pudiera afectar a la interpretación de los resultados del estudio o que suponga un riesgo elevado de complicaciones del tratamiento para el paciente.
    28. Opacidades medias significativas, incluidas cataratas, en el ojo de estudio que interfieran en la agudeza visual, la fotografía del fondo de ojo o la TCO.
    29. Mujeres lactantes.
    30. Asignación previa a tratamiento durante este estudio.
    31. Participación concomitante en otro estudio clínico con uno o varios medicamentos en investigación.
    32. Relación estrecha con el centro de investigación; p. ej., familiar cercano del investigador, persona dependiente (p. ej., empleado o estudiante del centro de investigación).
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Week 52 in the NEI VFQ 25 total score.
    Cambio desde el inicio del estudio hasta la semana 52 en la puntuación total en el NEI VFQ 25.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    Efficacy assessments:
    The change from baseline to Week 52 in the NEI VFQ 25 near activities subscale.
    The change from baseline to Week 52 in the NEI VFQ 25 distant activities subscale.
    The change from baseline to Week 52 in BCVA (ETDRS letter score).
    The change from baseline to Week 52 in CRT measured by OCT.
    Safety assessments:
    Intraocular pressure and adverse events every 4 weeks.
    Vital signs at baseline and at week 52.
    Valoración de la eficacia:
    1.El cambio desde el inicio del estudio hasta la semana 52 en la puntuación total en la subescala de actividades cercana del NEI VFQ 25
    2.El cambio desde el inicio del estudio hasta la semana 52 en la puntuación total en la subescala de actividades lejanas del NEI VFQ 25
    3.El cambio desde el inicio del estudio hasta la semana 52 en la MAVC (puntuación de las letras del ETDRS)
    4.El cambio desde el inicio del estudio hasta la semana 52 en el CRC medido mediante TCO
    Valoración de la seguridad:
    Presión intraocular y acontecimientos adversos cada 4 semanas.
    Constantes vitales en el inicio del estudio y en la semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (vital signs), every 4 weeks (intraocular pressure) and Week 52 (efficacy assessments and vital signs).
    Inicio (constantes vitales), cada 4 semanas (presión intraocular) y semana 52 (valoración de la eficacia y constantes vitales).
    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. 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 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 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 concerned6
    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
    Czech Republic
    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
    The end of the study as a whole will be reached as soon as the last visit of the last subject (LVLS) has been reached in all centres in all participating countries (EU and non-EU).
    El fin del estudio global tendrá lugar en cuanto se llegue a la última visita del último sujeto en todos los centros de todos los países participantes (de la UE y de fuera de la UE).
    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 months6
    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 months6
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 436
    F.4.2.2In the whole clinical trial 490
    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 the end of this study, subjects will not be restricted with regard to pursuing available treatments for DME.
    After completion of this study, subjects may subsequently be enrolled into the sponsor's post-approval efficacy study further investigating the efficacy of aflibercept in DME patients.
    Después del fin del estudio, los sujetos no tendrán limitación alguna en cuanto a los tratamientos disponibles para el EMD.
    Tras la finalización del estudio, los sujetos podrán inscribirse en el estudio de la eficacia posterior a la aprobación del promotor que seguirá investigando la eficacia del aflibercept en los pacientes con EMD.
    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 Decision2015-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-09
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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