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    Summary
    EudraCT Number:2010-022364-12
    Sponsor's Protocol Code Number:BAY86-5321/91745
    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:2011-01-19
    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 number2010-022364-12
    A.3Full title of the trial
    ESTUDIO DE FASE III, ALEATORIZADO, CON DOBLE SIMULACIÓN Y CONTROLADO CON TRATAMIENTO ACTIVO, DE LA EFICACIA Y LA SEGURIDAD DE DOSIS INTRAVÍTREAS REPETIDAS DE VEGF TRAP¬ EYE EN SUJETOS CON EDEMA MACULAR DIABÉTICO//


    A randomized, double masked, active controlled, phase III study of the efficacy and safety of repeated doses of intravitreal VEGF Trap-Eye in subjects with diabetic macular edema.
    A.4.1Sponsor's protocol code numberBAY86-5321/91745
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameVEGF Trap-Eye
    D.3.2Product code 80418745
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeBAY86-5321
    D.3.9.3Other descriptive nameVEGF Trap-Eye
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeProteina de fusion producida por recombinación// Recombinantly produced fusion protein
    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
    Edema macular diabético con afectación central//

    Diabetic macular edema with central involvement
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de la administración intravítrea (IVT) de VEGF Trap-Eye en comparación con el tratamiento con láser en la mejora de la agudeza visual con corrección (best corrected visual acuity, BCVA) en sujetos con edema macular diabético (DME) con afectación central//

    To assess the efficacy of intravitreally (IVT) administered VEGF Trap Eye in comparison to laser treatment in improving best corrected visual acuity (BCVA) in subjects with diabetic macular edema (DME) with central involvement
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad de la administración IVT de VEGF Trap-Eye en sujetos con DME//

    To evaluate the safety of IVT administered VEGF Trap Eye in subjects with DME
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-estudio farmacogenético de recogida de muestras de sangre para análisis de ADN//

    Pharmacogenetic sub-study for the the collection of blood samples for DNA analyses.
    E.3Principal inclusion criteria
    1. Adultos mayor o igual a 18 años con diabetes mellitus de tipo 1 o 2.
    2. Sujetos con DME secundario a diabetes mellitus que afecta a la fóvea (definida como el área del subcampo central del estudio de tomografía de
    coherencia óptica [OCT]) en el ojo en estudio.
    3. Disminución de la visión que se ha determinado que se debe fundamentalmente a un DME en el ojo en estudio.
    4. Grosor de retina mediante OCT de mayor o igual a 300 microm en el ojo en estudio.
    5. Puntuación de letras del ETDRS con mejor agudeza visual con corrección de 73 a 24 (20/40 a 20/320) en el ojo en estudio.
    6. Voluntad y capacidad de cumplir con las visitas a consulta y con los procedimientos del estudio.
    7. Firma del documento de consentimiento informado (ICF). //

    1. Adults mayor o igual a 18 years with type 1 or 2 diabetes mellitus.
    2. Subjects with DME secondary to diabetes mellitus involving the center of
    the macula (defined as the area of the center subfield of optical coherence tomography [OCT]) in the study eye.
    3. Decrease in vision determined to be primarily the result of DME in the study eye
    4.Retinal thickness as assessed by OCT of mayor o igual a 300 µm in the study eye.
    5.BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye.
    6.Willing and able to comply with clinic visits and study-related procedures.
    7.Provide a signed informed consent form (ICF)
    E.4Principal exclusion criteria
    1. Proceso ocular en el ojo contralateral con peor pronóstico que en el ojo en estudio.
    2. Antecedentes de cirugía vitreorretiniana con o sin indentación escleral en el ojo en estudio.
    3. Fotocoagulación con láser (panretiniana o macular) en el ojo en estudio en los 90 días
    anteriores al Día 1.
    4. Más de 2 tratamientos maculares con láser en el ojo en estudio o, en opinión del investigador, el sujeto no va a beneficiarse de los tratamientos con láser (por ejemplo, ha recibido muchos tratamientos con láser anteriormente).
    5. Uso previo de corticosteroides intraoculares o perioculares en el ojo en estudio en el plazo de los 120 días anteriores al Día 1.
    6. Tratamiento previo con fármacos anti antiangiogénicos en cualquier ojo (pegaptanib sódico, bevacizumab, ranibizumab, etc.) en el plazo de los 90 días anteriores al Día 1.
    7. Retinopatía proliferativa diabética (proliferative diabetic retinopathy, PDR) en el ojo en estudio, con la excepción de la PDR en regresión e inactiva.
    8. Antecedentes de uveítis idiopática o autoinmunitaria en el ojo en estudio.
    9. Cirugía de cataratas en el ojo en estudio en los 90 días anteriores al Día 1.
    10. Afaquia en el ojo en estudio.
    11. Capsulotomía mediante YAG en el ojo en estudio dentro de los 30 días anteriores al Día 1.
    12. Cualquier otra cirugía intraocular en el ojo en estudio dentro de los 90 días anteriores
    al Día 1.
    13. Tracción vitreomacular o membrana epirretiniana en el ojo en estudio evidente por biomicroscopía o por OCT que se considera que afecta a la visión central.
    14. Proceso actual de neovascularización del iris, hemorragia vítrea o desprendimiento traccional de retina en el ojo en estudio.
    15. Fibrosis prerretiniana que afecta a la mácula del ojo en estudio.
    16. Lesión estructural de la fóvea en el ojo en estudio que es probable que no permita la mejoría de la agudeza visual con corrección tras la resolución del edema macular, incluidos atrofia del epitelio pigmentario de la retina, fibrosis o cicatriz subretiniana, isquemia macular importante o exudados duros organizados.
    17. Inflamación en el ojo en estudio, aunque sólo sea residual.
    18. Demostración de blefaritis, queratitis, escleritis o conjuntivitis infecciosas en el ojo en estudio.
    19. Cirugía de filtración por glaucoma en el pasado, o probabilidad de necesitarla en el futuro en el ojo en estudio.
    20. Presión intraocular (IOP) mayor o igual a 25 mm Hg en el ojo en estudio.
    21. Miopía de un equivalente esférico, antes de toda posible cirugía refractiva o de cataratas, -8 dioptrías.
    22. Enfermedad concomitante en el ojo en estudio, distinta del DME, que pueda afectar a la agudeza visual, precisar intervención médica o quirúrgica durante el periodo del estudio o confundir la interpretación de los resultados, incluida la oclusión vascular retiniana, el desprendimiento de retina, el agujero macular o la neovascularización coroidea de cualquier causa).
    23. Sólo 1 ojo funcional, aunque sea por lo demás elegible para el estudio.
    24. Medios oculares de calidad insuficiente para obtener imágenes del fondo de ojo y de OCT.
    25. Tratamiento actual por infección sistémica grave.
    26. Administración de agentes anti-angiogénicos sistémicos en los 180 días anteriores al Día 1.
    27. Diabetes mellitus no controlada, definida por un valor de HbA1c mayor del 12%.
    28. Presión arterial no controlada (definida como sistólica mayor de 160 mm Hg o diastólica mayor de 95 mm Hg con el sujeto sentado).
    29. Antecedentes de accidente vascular cerebral y/o infarto de miocardio en los 180 días anteriores al Día 1.
    30. Insuficiencia renal que precisa diálisis o trasplante renal.
    31. Antecedente de otra enfermedad, disfunción metabólica, hallazgo de la exploración física o de laboratorio que conlleve una sospecha razonable de enfermedad o proceso que contraindique el uso de un medicamento en investigación, que pueda afectar a la interpretación de los resultados del estudio o que coloque al sujeto en un alto riesgo de presentar complicaciones del tratamiento.
    32. Mujeres embarazadas o en lactancia. Además, a fin de prevenir la exposición durante el embarazo, las mujeres, los hombres y sus parejas deberán mostrar su conformidad en lo siguiente:
    33. No podrán participar las mujeres potencialmente fértiles con un resultado positivo en una prueba de embarazo o sin prueba de embarazo en el momento basal. Para poder ser consideradas como no potencialmente fértiles, las mujeres posmenopáusicas deberán encontrarse en amenorrea desde como mínimo 12 meses antes.
    34. No podrán participar los hombres o mujeres potencialmente fértiles que sean sexualmente activos que no deseen practicar una anticoncepción adecuada durante el estudio.
    35. Alergia a la fluoresceína.
    36. Participación en un estudio de investigación en los 30 días previos a la visita de selección que haya supuesto el tratamiento con cualquier tipo de fármaco (excluidas las vitaminas y los minerales) o dispositivo sanitario.
    E.5 End points
    E.5.1Primary end point(s)
    Las dos principales variables son cambio de la agudeza visual con corrección en la puntuación de letras del ETDRS desde el momento basal hasta la Semana 52 y hasta la semana 100.//

    The two primary endpoints are the absolute mean change from baseline in BCVA as measured by ETDRS letters at Week 52 and at Week 100 compared to baseline.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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
    Fotocoagulación macular con láser //macular laser photocoagulation
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    El final del estudio es la última visita del último paciente//

    End of trial is last visit of last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 292
    F.4.2.2In the whole clinical trial 375
    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)
    El mismo tratamiento habitual esperado para esta enfermedad//

    Not different from the expected normal treatment of that condition.
    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 Decision2011-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-14
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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