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    The EU Clinical Trials Register currently displays   43926   clinical trials with a EudraCT protocol, of which   7306   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:2022-000690-73
    Sponsor's Protocol Code Number:BAY86-5321/21912
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-08-29
    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 number2022-000690-73
    A.3Full title of the trial
    A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept with Proactive customized Treatment Intervals in Patients >/=50 Years of Age with No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation with Aflibercept
    Estudio de fase 4, de grupos paralelos, abierto y de dos grupos, para evaluar la seguridad y la eficacia de aflibercept intravítreo (IVT) con intervalos de tratamiento individualizados proactivamente en pacientes >/=50 años sin líquido como consecuencia de lesiones de neovascularización coroidea (CNV) secundarias a degeneración macular neovascular (húmeda) relacionada con la edad (nAMD) tras el inicio del tratamiento con aflibercept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how well Aflibercept injected into the eye works and how safe it is when given in customized treatment intervals in patients with an eye disease called neovascular age-related macular degeneration after start of treatment
    Estudio para conocer la eficacia y la seguridad del aflibercept en inyección ocular, administrado a intervalos de tratamiento personalizados en pacientes con la enfermedad ocular denominada degeneración macular neovascular relacionada con la edad, tras el inicio del tratamiento
    A.3.2Name or abbreviated title of the trial where available
    XPAND
    XPAND
    A.4.1Sponsor's protocol code numberBAY86-5321/21912
    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 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 AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer 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 AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.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
    D.2.1.1.2Name of the Marketing Authorisation holderBayer 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.3.2Product code BAY 86-5321
    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
    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 Yes
    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 (wet) age-related macular degeneration
    Degeneración macular neovascular (húmeda) relacionada con la edad
    E.1.1.1Medical condition in easily understood language
    An eye disorder caused by abnormal blood vessels that leak fluid into the central part of the retina at the back of the eye leading to blurring or a blind spot in the central (straight ahead) vision
    Trastorno ocular por vasos sanguíneos anormales que filtran líquido en la parte central de la retina en la parte posterior del ojo causando visión borrosa o un punto ciego en la visión central(frente)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether 2 mg intravitreal (IVT) aflibercept administered at a customized treatment interval (determined after the first extended treatment interval) is non-inferior to 2 mg IVT aflibercept administered according to a standard treat and extend (T&E) regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for neovascular (wet) age-related macular degeneration (nAMD)
    Evaluar si 2 mg de aflibercept intravítreo (IVT) administrados en un intervalo de tratamiento individualizado (determinado después del primer intervalo de tratamiento extendido) no es inferior a 2 mg de aflibercept IVT administrados de acuerdo con una pauta estándar de “tratar y extender” (T&E) (iniciada después del primer intervalo de tratamiento extendido) en pacientes sin líquido después del inicio del tratamiento de la degeneración macular neovascular (húmeda) relacionada con la edad (nAMD)
    E.2.2Secondary objectives of the trial
    1. To assess treatment burden of 2 mg IVT aflibercept administered at a customized treatment interval compared with 2 mg IVT aflibercept administered according to a standard T&E regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for nAMD
    2. To evaluate the safety of aflibercept with proactive treatment intervals
    1. Evaluar la carga del tratamiento con 2 mg de aflibercept IVT administrados en un intervalo de tratamiento individualizado, en comparación con 2 mg de aflibercept IVT administrados según una pauta estándar de T&E (iniciada después del primer intervalo de tratamiento extendido), en pacientes sin líquido después del inicio del tratamiento de la nAMD
    2. Evaluar la seguridad del aflibercept con intervalos de tratamiento establecidos proactivamente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member), understand, and willing to sign the ICF.
    2. Men and women >/=50 years of age.
    3. At treatment initiation, active macular neovascular lesions secondary to nAMD (Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the electronic case report form [eCRF]).
    4. Treatment initiation with 3 × monthly IVT aflibercept injections (Weeks -16, -12, and -8 to planned study baseline visit) resulting in absence of any fluid at week -8.
    5. ETDRS BCVA of at least 25 letters (20/320 Snellen equivalent) in the study eye at screening visit.
    6. Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
    7. Able to use the provided monitoring device and willing to perform 5 × weekly self-assessments in the Investigator´s opinion.
    8. 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 ICF and 3 months after the last administration of study drug.
    1. Consentimiento informado por escrito: con capacidad de leerlo (o, si no puede hacerlo por discapacidad visual, de que la persona que administre el consentimiento informado o un familiar se lo lea textualmente) y comprenderlo y estar dispuesto a firmarlo.
    2. Hombres y mujeres con edad >/=50 años.
    3. Al inicio del tratamiento, lesiones neovasculares maculares activas secundarias a la degeneración macular neovascular relacionada con la edad (nAMD) (podrán participar en el estudio los pacientes con vasculopatía coroidea polipoidea o proliferación angiomatosa de la retina, cuya afección deberá registrarse en el cuaderno de recogida de datos electrónico [eCRF]).
    4. Inicio del tratamiento con 3 × inyecciones mensuales de aflibercept IVT (Semanas -16, -12, y -8 hasta la visita basal del estudio prevista), con resultado de ausencia de líquido en la semana -8.
    5. Mejor agudeza visual con corrección (BCVA) mediante el optotipo del Estudio del tratamiento temprano de la retinopatía diabética (ETDRS) de como mínimo 25 letras (equivalente a 20/320 de Snellen) en el ojo del estudio en la visita de selección.
    6. Con disposición, compromiso y capacidad de acudir a todas las visitas al centro y completar todos los procedimientos del estudio.
    7. Con capacidad para utilizar el dispositivo de monitorización facilitado y con disposición a realizar 5 × autoevaluaciones semanales, a juicio del investigador.
    8. Las mujeres y los hombres con potencial reproductivo deben aceptar el uso de métodos anticonceptivos adecuados durante la actividad sexual. Lo anterior se aplica al periodo de tiempo entre la firma del documento de consentimiento informado y 3 meses después de la última administración del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Any contraindication to IVT anti-VEGF treatment or treatment with Eylea® as detailed in the Summary of Product Characteristics (SmPC).
    2. Any prior ocular (in the study eye) or systemic treatment (including investigational agents) or surgery for nAMD, except the 3 × monthly IVT aflibercept injections required for treatment initiation and dietary supplements or vitamins.
    3. Any presence of intraretinal and subretinal fluid.
    4. Any ocular or systemic condition expected to interfere with study outcomes and procedures, including but not limited to:
    • Scar, fibrosis or other lesions (e.g., retinal pigment epithelium [RPE] tears, macular hole stage 2 or above and others) involving the center of the macula in the study eye.
    • Clinically relevant opacities or conditions involving the optic media including cataract, corneal dystrophies or s.p. corneal transplant in the study eye.
    • Uncontrolled glaucoma (defined as IOP >/=25 mm Hg despite treatment with antiglaucoma medication) in the study eye or prior trabeculectomy or other filtration surgery in the study eye.
    • Intraocular surgery, periocular surgery, or cataract surgery within 90 days before Day 1 in the study eye, except the IVT aflibercept injections required for treatment initiation and any history of vitrectomy, retinal radiation therapy, retinal detachment or treatment or surgery for retinal detachment in the study eye.
    • Aphakia or pseudophakia with absence of posterior capsule (unless as a result of an yttrium aluminum garnet posterior capsulotomy) in the study eye.
    5. Participation as a patient in any clinical study within 12 weeks before screening.
    6. 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).
    7. Previously screen failed patients for this study.
    1. Toda contraindicación al tratamiento anti-VEGF IVT o al tratamiento con Eylea® como se detalla en la ficha técnica del producto.
    2. Todo tratamiento ocular (en el ojo del estudio) o sistémico (incluidos los productos en investigación) anterior o cirugía para la nAMD, excepto las 3 × inyecciones mensuales de aflibercept IVT necesarias para el inicio del tratamiento y los suplementos dietéticos o vitaminas.
    3. Presencia de líquido intrarretiniano y subretiniano.
    4. Todo trastorno ocular o sistémico que previsiblemente vaya a interferir en los resultados y procedimientos del estudio, incluidos, entre otros, los siguientes:
    • Cicatriz, fibrosis u otras lesiones (p. ej., desgarros del epitelio pigmentario de la retina, agujero macular en fase 2 o superior y otras) que afecten al centro de la mácula en el ojo del estudio.
    • Opacidades o afecciones clínicamente importantes que afecten a los medios transparentes, como cataratas, distrofias corneales o trasplante de córnea anterior en el ojo del estudio.
    • Glaucoma no controlado (definido como presión intraocular >/=25 mmHg a pesar del tratamiento con medicación antiglaucomatosa) en el ojo del estudio o trabeculectomía anterior u otra cirugía de filtración en el ojo del estudio.
    • Cirugía intraocular, periocular o de cataratas en el ojo del estudio en el plazo de 90 días antes del día 1, excepto las inyecciones de aflibercept IVT necesarias para el inicio del tratamiento, y todo antecedente de vitrectomía, radioterapia retiniana, desprendimiento de retina o tratamiento o cirugía de desprendimiento de retina en el ojo del estudio.
    • Afaquia o pseudofaquia con ausencia de cápsula posterior (a no ser que sea resultado de una capsulotomía posterior con láser de granate de itrio y aluminio) en el ojo del estudio.
    5. Participación como paciente en cualquier estudio clínico en el plazo de las 12 semanas anteriores a la selección.
    6. Estrecha vinculación con el centro de investigación; p. ej., familiar cercano del investigador, persona dependiente (p. ej., empleado o estudiante del centro de investigación).
    7. Pacientes que hayan sido fracasos de selección en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change in best-corrected visual acuity (BCVA) (early treatment diabetic retinopathy study [ETDRS] letters)
    Cambio en la mejor agudeza visual con corrección (BCVA) (letras del Estudio sobre el tratamiento precoz de la retinopatía diabética [ETDRS])
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 36
    Desde el momento basal hasta la Semana 36
    E.5.2Secondary end point(s)
    1. Number of IVT aflibercept injections per patient
    2. Number of IVT aflibercept injections per patient
    3. Number of patients achieving pre-defined treatment intervals (>/=4, >/=8, >/=10, >/=12¸ >/=14, and 16 weeks)
    4. Change in BCVA (ETDRS letters)
    5. Number of subjects with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
    1. Número de inyecciones de aflibercept IVT por paciente
    2. Número de inyecciones de aflibercept IVT por paciente
    3. Número de pacientes que logren intervalos de tratamiento predefinidos (>/=4, >/=8, >/=10, >/=12, >/=14 y de 16 semanas)
    4. Cambio en la BCVA (letras ETDRS)
    5. Número de sujetos con acontecimientos adversos surgidos en el tratamiento (TEAE) y acontecimientos adversos graves surgidos en el tratamiento (TESAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline up to Week 52
    2. From baseline up to Week 36
    3. At Weeks 36 and 52
    4. From baseline up to Week 52
    5. From baseline up to Week 36 and Week 52
    1. Desde el momento basal hasta la Semana 52
    2. Desde el momento basal hasta la Semana 36
    3. En las Semanas 36 y 52
    4. Desde el momento basal hasta la Semana 52
    5. Desde el momento basal hasta la Semana 36 y la 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 No
    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 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 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
    Régimen habitual de "tratar y extender" con ajuste cada 2 semanas
    Standard treat and extend regimen-2 week-adjustment
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    France
    Spain
    Germany
    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
    Last subject last visit
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days11
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 108
    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 Decision2023-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-21
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