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    Summary
    EudraCT Number:2019-003204-12
    Sponsor's Protocol Code Number:ICI21/00025
    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:2021-12-29
    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 number2019-003204-12
    A.3Full title of the trial
    Multicentre, randomised, double-blind, parallel-group, Phase III study to evaluate the genetic polymorphisms influence in the response to Ranibizumab and Bevacizumab treatment in patients with Age-Associated Macular Degeneration.
    Ensayo clínico multicéntrico, aleatorizado, doble ciego, de grupos paralelos, fase III para evaluar la influencia del polimorfismo genético en la respuesta del tratamiento de ranibizumab y bevaciumab en pacientes con Degeneración Macular Asociada a la Edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacogenomics of antiVEGF in patients with Age-Associated Macular Degeneration.
    FArmacogenómica de los antiVEGF en pacientes con Degeneración Macular Asociada a la Edad.
    A.3.2Name or abbreviated title of the trial where available
    ICI21/00025
    ICI21/00025
    A.4.1Sponsor's protocol code numberICI21/00025
    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 SponsorConsorcio PSMAR
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEU Next Generation
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIMIM
    B.5.2Functional name of contact pointJulia Serra
    B.5.3 Address:
    B.5.3.1Street AddressDr Aiguder 88
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number34933160496
    B.5.6E-mailjserra@imim.es
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GMBH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAVASTIN 25 MG/ML
    D.3.2Product code 650602
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLucentis
    D.3.2Product code 106374003
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    age-related macular degeneration
    Degeneración macular asociada a la edad
    E.1.1.1Medical condition in easily understood language
    age-related macular degeneration
    Degeneración macular asociada a la edad
    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 10025409
    E.1.2Term 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
    1. To evaluate the influence of the following genetic polymorphisms on a saliva sampling: VEGFA, CFH, CTFG, ARMS2, HTRA1, OR52B4, LOC387715, LOC100287225, LEPR, SERPINF1 in the response to treatment of the two drugs.
    1. Evaluar la influencia de los siguientes polimorfismos genéticos en una muestra de saliva: VEGFA, CFH, CTFG, ARMS2, HTRA1, OR52B4, LOC387715, LOC100287225, LEPR, SERPINF1 en la respuesta al tratamiento de los dos fármacos.
    E.2.2Secondary objectives of the trial
    2. To evaluate the influence of the sex, age, smoking, obesity, hypertension and VA at the time of diagnosis of AMD in the response to treatment of the two drugs
    3. To evaluate the safety profile of ranibizumab and bevacizumab intravitreal injections, cardiovascular events included, after 3 injections and three years of follow-up.
    4. To evaluate the economic impact (SNS perspective) of the use of ranibizumab and bevacizumab after one year of treatment, taking into account the drug and monitoring.
    2. Evaluar la influencia del sexo, la edad, el tabaquismo, la obesidad, la hipertensión y la AV en el momento del diagnóstico de DMAE en la respuesta al tratamiento de los dos fármacos.
    3. Evaluar el perfil de seguridad de las inyecciones intravítreas de ranibizumab y bevacizumab, eventos cardiovasculares incluidos, tras 3 inyecciones y tres años de seguimiento.
    4. Evaluar el impacto económico (perspectiva SNS) del uso de ranibizumab y bevacizumab al año de tratamiento, teniendo en cuenta el fármaco y el seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients diagnosed with neovascular Age-related Macular Degeneration and:
    • Age of 50 years or older.
    • That at the discretion of the ophtalmologist has an indication of receiving treatment with an anti VEGF agent as usual in clinical practice.
    • Without previous treatment in the eye under study (no previous treatment for AMD).
    Pacientes diagnosticados con degeneración macular relacionada con la edad neovascular y:
    • Edad de 50 años o más.
    • Que a criterio del oftalmólogo tiene indicación de recibir tratamiento con un agente anti VEGF como es habitual en la práctica clínica.
    • Sin tratamiento previo en el ojo en estudio (sin tratamiento previo para la DMAE).
    E.4Principal exclusion criteria
    • Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
    • Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
    • Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
    • High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.
    • Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.
    • Hypersensitivity to the active substance or to the excipients.
    • Diabetic retinopathy documented.
    • Pregnant or nursing (lactating) women.
    • Participar o haber participado en otro ensayo clínico con un fármaco experimental en los últimos 6 meses.
    • Pacientes con otras enfermedades oculares, pág. por ejemplo, glaucoma avanzado o cataratas visualmente significativas, que probablemente requieran cirugía durante el período de seguimiento en el ojo en estudio.
    • Administración concomitante, ocular o sistémica de fármacos hasta 3 meses antes del tratamiento con otro anti-VEGF en el ojo contralateral.
    • Alto riesgo cardiovascular: hipertensión arterial mal controlada, antecedentes o riesgo de eventos tromboembólicos arteriales, antecedentes de ictus o infarto agudo de miocardio, tratamiento anticoagulante, proteinuria o cirugía mayor electiva en 3 meses.
    • Riesgo oftalmológico con la inyección intraocular (todos los tratamientos intravítreos): infección ocular o periocular activa o sospechada, blefaritis grave, antecedentes de endoftalmitis, antecedentes de desprendimiento de retina, miopatía, glaucoma.
    • Hipersensibilidad al principio activo oa los excipientes.
    • Retinopatía diabética documentada.
    • Mujeres embarazadas o en período de lactancia (lactantes).
    E.5 End points
    E.5.1Primary end point(s)
    - Visual acuity score measured on ETDRS at 4 meters of initial distance or Snellen with conversion to ETDRS if necessary, using the method proposed by Rosenfeld et al

    - OCT criteria: presence of intraretinal and / or subretinal fluid, the presence of drusen or pigment epithelial detachment, and central macular subfield thickness (defined as the sum of the thickness of the central neurosensory retina, including eventual intraretinal fluid, and the height of the eventual subretinal fluid [central subfield macular thickness measures the thickness of a circular area of 1 mm, concentric to the foveal center]).
    - Puntaje de agudeza visual medido en ETDRS a 4 metros de distancia inicial o Snellen con conversión a ETDRS si es necesario, utilizando el método propuesto por Rosenfeld et al.
    - Criterios OCT: presencia de líquido intrarretiniano y / o subretiniano, presencia de drusas o desprendimiento del epitelio pigmentario y espesor del subcampo macular central (definido como la suma del espesor de la retina neurosensorial central, incluido el eventual líquido intrarretiniano, y la altura de el eventual líquido subretiniano [el grosor macular del subcampo central mide el grosor de un área circular de 1 mm, concéntrica al centro foveal]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Visual acuity score measured at baseline, 6m, 1, 2 and 3 years

    - OCT criteria at baseline and 6m and 1, 2 and 3 years
    - Puntaje de agudeza visual medido basal, 6 meses, 1 año, 2 años y 3 años después de la primera administración.

    - Criterios OCT medido al inicio del estudio, 6 meses, 1 año, 2 años y 3 años después de la primera administración.
    E.5.2Secondary end point(s)
    Adverse events
    Withdrawal reasons
    Eventos adversos
    Razones de retirada
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events at 6m, 1,2,3 years of follow-up
    Withdrawal reasons detected at 6m, 1,2,3 years of follow-up
    eventos adversos a los 6 meses, uno, dos y tres años de seguimiento
    razones de retirada detectados a los 6 meses, uno, dos y tres años de seguimiento
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    last visit of the last subject undergoing the trial
    última visita del último paciente reclutado
    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 months6
    E.8.9.1In the Member State concerned days
    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: 330
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state630
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 630
    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)
    Patients will receive the health cares in clinical practice as usual.
    Los pacientes recibirán los cuidados de salud por práctica clínica habitual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SCREN
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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