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    Summary
    EudraCT Number:2012-004873-14
    Sponsor's Protocol Code Number:NL_42463.068.12
    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:2015-04-27
    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 number2012-004873-14
    A.3Full title of the trial
    PREvention of Macular EDema after cataract surgery
    PREvención del EDema Macular después de cirugía de cataratas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of macular edema after cataract surgery
    Prevención del edema macular después de la cirugía de cataratas
    A.3.2Name or abbreviated title of the trial where available
    PREMED
    PREMED
    A.4.1Sponsor's protocol code numberNL_42463.068.12
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01774474
    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 SponsorUniversity Eye Clinic Maastricht
    B.1.3.4CountryNetherlands
    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 supportESCRS (European Society of Cataract & Refractive Surgeons)
    B.4.2CountryIreland
    B.4.1Name of organisation providing supportBausch + Lomb
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Eye Clinic Maastricht
    B.5.2Functional name of contact pointLaura H.P. Wielders, PhD student
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 5800
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6202 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-maillaura.wielders@mumc.nl
    D. IMP Identification
    D.IMP: 1
    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 Yellox
    D.2.1.1.2Name of the Marketing Authorisation holderCroma-Pharma 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 nameBromfenac
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBROMFENAC
    D.3.9.1CAS number 91714-94-2
    D.3.9.3Other descriptive nameYellox
    D.3.9.4EV Substance CodeSUB05913MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Dexamethasone disodium phosphate
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    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 nameDexamethasone disodium phosphate
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE disodium phosphate
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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: 3
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameBevacizumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.3Other descriptive nameAvastin
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 4
    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 Triesence or Vistrec
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon
    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 nameTriamcinolone Acetonide
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubconjunctival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIESENCE
    D.3.9.1CAS number 124-94-7
    D.3.9.3Other descriptive nameTRIAMCINOLONE ACETONIDE
    D.3.9.4EV Substance CodeSUB04936MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Cystoid Macular Edema (CME) after cataract surgery
    Edema macular cistoide (EMC) posterior a la cirugía de catarata
    E.1.1.1Medical condition in easily understood language
    Macular edema after cataract surgery
    Inflamación de la mácula (edema macular) como complicación a la cirugía de cataratas.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint is the change in central subfield mean macular thickness (CSMT) as compared to baseline at 6 weeks postoperatively.
    El objetivo principal es valorar el cambio en el grosor medio del subcampo macular central (CSMT) comparado con la visita basal y a las 6 semanas después de la intervención de cataratas.
    E.2.2Secondary objectives of the trial
    The secondary endpoint is the occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively.
    Other study endpoints are:
    mean CDVA in logMAR at 6 and 12 weeks postoperatively;
    CSMT 12 weeks postoperatively;
    OCT measured average retinal thickness in the inner circle (3mm), the outer circle (6mm), and the macular volume at 6 and 12 weeks postoperatively;
    intraocular pressure at 6 and 12 weeks postoperatively;
    health-related and vision-related quality of life at 12 weeks postoperatively;
    incremental cost-effectiveness ratios of the costs per quality-adjusted life year (QALY) and costs per improved patient on the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) and Health Utility Index (HUI-3).
    Objetivo secundario es valorar la aparición de edema macular postoperatorio clinicamente significativo en las 12 semans (EMCS) en las 12 semanas posteriores a la intervención de cataratas.
    Otros objetivos del estudio son:
    - Agudeza visual media en log MAR a las 6 y a las 12 semanas tras la intervención de cataratas.
    - Grosor medio del subcampo macular central a las 12 semanas tras la intervención de cataratas.
    - Media del grosor retiniano en el círculo central (3 mm) y en el círculo exterior (6 mm) medio con OCT.
    - Media de la tensión ocular a las 6 y a las 12 semanas tras la intervención de cataratas.
    - Calidad de vida relacionado con la salud y la visión a las 12 semanas tras la intervención de cataratas.
    - Proporción de aumento "coste-efectividad" por calidad de vida anual (QALY) y los costes por mejora del paciente (National Eye Intensive Visual Functioning Questionnaire NEI VQF-25) e índice útil de salud (HUI-3).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients undergoing routine phacoemulsification.
    Only one eye per patient will be included in the study.
    Patients should be able to communicate properly and understand instructions.
    All patients must accept possible off-label use of study medication before inclusion in this study.
    Todos los pacientes que requieran facoemulsificación podrán ser incluídos en el estudio, excepto todos aquellos que se definen en la sección ?criterios de exclusión? y todos aquellos que no deseen participar o aquellos pacientes que no serán capaces de acudir a las visitas ni a las pruebas post operatorias. Los pacientes deberán ser capaces de comunicarse correctamente y entender las instrucciones. Únicamente se puede incluir en el estudio un ojo por paciente.
    Todos los pacientes serán informados sobre los usos de las medicaciones de estudio bevacizumab intravitreo y /o la inyección subconjuntival de triamcinolona acetonida sin conservantes y deben aceptarlo antes de ser incluidos en el estudio . (se tratan de medicaciones que se emplean en el uso oftalmológico pero no están registradas como tal)
    E.4Principal exclusion criteria
    Study procedures will be different for diabetic and non-diabetic patients. Therefore, the exclusion criteria will also be different for diabetic and non-diabetic patients.

    General Eexclusion criteria for participation in this study are:
    1. age below 21 years old;
    2. participation in another clinical study;
    3. post-traumatic cataract;
    4. combined surgery;
    5. functional monoculus;
    6. previous ocular surgery;
    7. progressive glaucoma with severe visual field defects, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
    8. IOP ? 25 mmHg;
    9. history of intraocular inflammation or uveitis;
    10. history of pseudoexfoliation syndrome, which is expected to cause peroperative complications;
    11. history of Fuchs' endothelial dystrophy or cornea guttata 3+;
    12. history of retinal vein occlusion;
    13. any macular pathology that might influence VA, other than DME
    14. use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks;
    15. use of intra- or periocular corticosteroid injection in the previous 4 months;
    16. current use of topical NSAIDs or corticosteroids;
    17. use of systemic corticosteroids (? 20 mg prednisolone or equivalence);
    18. history of relevant adverse events, including serious adverse events (SAE), occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
    19. contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs

    Non-diabetic patients with a history of CME will be excluded from participation in the study.

    Additionally, diabetic patients will be excluded from participation in case of:
    1. macular edema with a CSMT ?450 µm;
    2. very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy;
    3. vitreous haemorrhage present during preoperative visit(s);
    4. cerebrovascular accident (CVA), myocardial infarction (MI) or other thromboembolic events in the previous 3 months;
    5. a history of recurrent thromboembolic events;
    6. a history of severe systemic bleeding in the previous 3 months;
    7. major surgery in the previous 3 months;
    8. history of glaucoma;
    Los procedimientos a realizar durante el estudio serán diferentes si el paciente es o no diabeto. Por lo tanto, los criterios de exclusión también serán diferentes para los pacientes diabéticos y no diabéticos.
    Criterios de exclusión generales
    Los criterios de exclusión generales para la participación e este estudio son:
    1.-Edad inferior a 21 años
    2.-Participación en otro estudio de investigación
    3.-Catarata post traumática
    4.-Cirugía combinada (por ejemplo facoemulsificiación y trabeculectomía o facoemulsificación y queratoplastia lamelar.
    5.-Un solo ojo funcional
    6.-Cirugía ocular previa
    7.-Glaucoma progresivo con defectos severos en el campo visual, uso de medicación antiglaucomatosa o esteroidea que pueda inducir aumento de tensión ocular que requiera tratamiento con hipotensores oculares.
    8.- Tensión intraocular mayor o igual a 25 mmHg
    9.-Historia de inflamación intraocular o uveítis
    10.-Historia de síndrome pseudo-exfoliativo, que haga sospechar que pueda causar complicaciones intraquirúrgicas(por ejemplo defectos de transiluminación en los bordes pupilares o zonulosis)
    11.-Historia de distrofia endotelial de Fuchs o cornea gutata 3+
    12.-Historia de oclusión venosa retiniana
    13.- Cualquier patología macular que pueda influir en la AV a parte de la DMAE
    14.-Uso intravitreo o periocular de bevacizumab o ranibizumab en las 6 semanas previas o aflibercept intravitreo en las 10 semanas previas
    15.- Uso intravitreo o periocular de inyecciones corticoesteroides en los 4 meses previos
    16.- Uso actual de antiinflamatorios no esteroideos o corticoesteroideos
    17.-Uso de corticoids sistémicos (dosis mayor o igual a prednisona o equivalente)
    18.-Historia de acontecimientos adversos relevantes, incluyendo efectos adversos severos (SAE) ocurridos después de la administración de anti inflamatorios no esteroideos, ácido acetilsalicílico, sulfito de sodio, corticoesteroides o bevacizumab
    19.-Contraindicaciones pare el uso de : anti inflamatorios tópicos no esteroideos, tratamiento corticoideo tópico o subconjuntival o bevacizumab intravitreo o medicamentos relacionados (por ejemplo tuberculosis, embarazo, planes de embarazo para los próximos 6 meses , madres lactantes.)
    E.5 End points
    E.5.1Primary end point(s)
    Central subfield macular thickness (CSMT) on OCT
    Cambio en el grosor medio del subcampo macular central (CSMT) en la OCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (preoperative or one day postoperative if preoperative OCT was of insufficient quality), 6 and 12 weeks postoperative
    En la visita basal (preoperatoria o máximo un día tras la intervención en el caso que la OCT antes de la cirugía sea de muy baja calidad) y 6 y 12 semanas tras la intervención de cataratas.
    E.5.2Secondary end point(s)
    The occurrence of postoperative clinically significant macular edema within 12 weeks postoperative
    Best corrected visual acuity (BCVA)
    Intraocular pressure (IOP)
    Health-related and vision-related quality of life
    Adverse events
    - La ocurrencia de edema macular clínicamente significativo durante las 12 semanas siguientes a la intervención de cataratas.
    - Mejor agudeza visual corregida (MAVC)
    - Presión intraocular (PIO)
    - Calidad de vida relacionada con la salud y la visión
    - Acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Preoperative and 6 and 12 weeks postoperative
    Antes de la intervención y 6 y 12 semanas tras la cirugía de cataratas.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    6 months after surgery of the last patient
    6 meses tras la cirugía del último paciente incluido.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1350
    F.4.2.2In the whole clinical trial 1350
    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)
    If applicable, patients will be treated according to the standard of care in the participating centre.
    Si aplica, los pacientes serán tratados según practica clínica habitual del centro.
    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 Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
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