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    Summary
    EudraCT Number:2014-005259-20
    Sponsor's Protocol Code Number:OFT-ETAMSILATO-4.2.1
    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:2015-01-16
    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 number2014-005259-20
    A.3Full title of the trial
    FASE IV-II CLINICAL TRIAL, PROOF OF CONCEPT, RANDOMIZED, SIMULATED CONTROLLED TREATMENT, DOUBLE BLINDED AND UNICENTRIC WITH TWO PARALLEL GROUPS, TO EVALUATE SAFETY AND EFFICACY OF INTRAVITREAL ADMINISTRATION OF ETAMSILATO IN THE IMPROVEMENT OF VISUAL ACUITY IN PATIENTS WITH AGE RELATED MACULA DEGENERATION.
    ENSAYO CLÍNICO DE FASE IV-II, PRUEBA DE CONCEPTO, ALEATORIZADO, CONTROLADO CON TRATAMIENTO FINGIDO, CON DOBLE-ENMASCARAMIENTO Y UNICÉNTRICO, CON DOS GRUPOS PARALELOS, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE LA ADMINISTRACIÓN INTRAVÍTREA DE ETAMSILATO EN LA MEJORÍA DE LA AGUDEZA VISUAL 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
    FASE IV-II CLINICAL TRIAL, PROOF OF CONCEPT, RANDOMIZED, SIMULATED AND BLINDED CONTROLLED TREATMENT, WITH TWO GROUPS, IN ONE HOSPITALTO EVALUATE SAFETY AND EFFICACY OF A DRUG ADMINISTERED VIA A NEEDLE IN THE EYE TO IMPROVE THE VISUAL ACUITY IN PATIENTS WITH AGE RELATED MACULA DEGENERATION.
    ENSAYO CLINICO FASE IV-II, DE COMPROBACIÓN, DISTRIBUIDO AL AZAR, CONTROLADO Y ENMASCARADO CON TRATAMIENTO FINGIDO, EN DOS GRUPOS, REALIZADO EN UN SOLO HOSPITAL, PARA EVALUAR EFICACIA Y SEGURIDAD AL ADMINISTRAR UN MENDICAMENTO MEDIANTE UN PINCHAZO EN EL OJO, PARA MEJORAR LA AGUDEZA VISUAL EN PACIENTES CON DEGENERACION MACULAR ASOCIADA A LA EDAD.
    A.4.1Sponsor's protocol code numberOFT-ETAMSILATO-4.2.1
    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 SponsorInvestigacion Independiente
    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 supportDR. PEDRO CUEVAS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeón Research S.L.
    B.5.2Functional name of contact pointRocio Garcia Cañamaque
    B.5.3 Address:
    B.5.3.1Street AddressBurgo Nuevo 16, 1-G
    B.5.3.2Town/ cityLeón
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034987261064
    B.5.5Fax number0034987216243
    B.5.6E-mailrgcanamaque@leonresearch.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 DICYNONE 250 mg/2 ml, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical 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 INNEtamsylate
    D.3.9.1CAS number 2624-44-4
    D.3.9.3Other descriptive nameETAMSYLATE
    D.3.9.4EV Substance CodeSUB11943MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Aged related macula degeneration (ARMD)
    Degeneración macular asociada a la edad (DMAE)
    E.1.1.1Medical condition in easily understood language
    Aged related macula 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 17.1
    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
    Stablish the efficacy after 4 weeks of a unique intravitreal injection with Etamsilato in the improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease
    Establecer la eficacia a las 4 semanas de una inyección única intravítrea de etamsilato en la mejora de la agudeza visual en pacientes diagnosticados de DMAE seca o exudativa
    E.2.2Secondary objectives of the trial
    Efficacy
    - Evaluate the Efficacy after 16 weeks of a unique intravitreal injection of Etamsilato in the improvement of the visual acuity in patients diagnosed of dry or wet ARMD
    - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato to revert the structural changes in the retina associated to ARMDafter 4 and 16 weeks of treatment
    - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato in the improvement of the contrast sensibility evolution after 4 and 16 weeks of treatment
    - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato on the quality of life of patients after 4 and 16 weeks of treatment

    Safety
    - Incidence of Serious and severe Adverse Events related with the intravitreal etamsylato during 16 weeks after the unique injection
    - Evaluate the changes in the intraocular pressure after the intravitreal etamsylato injection and the during 16 weeks after the unique injection
    Eficacia
    - Evaluar la eficacia a las 16 semanas de una inyección única intravítrea de etamsilato en la mejora de la agudeza visual en pacientes diagnosticados de DMAE seca o exudativa
    - Evaluar la eficacia de una inyección única intravítrea de etamsilato para revertir los cambios estructurales de la retina asociados a la DMAE a las 4 y las 16 semanas de tratamiento
    - Evaluar la eficacia de una inyección única intravítrea de etamsilato en la mejora de la sensibilidad al contraste a las 4 y las 16 semanas de tratamiento
    - Evaluar los efectos de una inyección única intravítrea de etamsilato sobre la calidad de vida de los pacientes a las 4 y 16 semanas de tratamiento
    Seguridad
    -Evaluar la incidencia de acontecimientos adversos según su severidad, gravedad, relación con etamsilato intravítreo durante 16 semanas tras la inyección única
    -Evaluar los cambios en la presión intraocular tras la inyección intravítrea de etamsilato y su evolución a lo largo de 16 semanas tras el tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Both genders adult patients (more than 18 years old)
    - Dry or wet ARMD, diagnosed within a maximum period of 2 years before
    - Best visual acuity corrected between 20/25 and 20/320, evaluated with optotype ETDRS
    - Able and in agreement to follow the study protocol and to give the inform consent
    - Pacientes adultos (18 años o más) de ambos sexos.
    - Pacientes con DMAE seca o exudativa, diagnosticada en el plazo máximo de los dos años previos
    - Pacientes que presenten una mejor agudeza visual corregida entre 20/25 y 20/320, evaluada mediante el optotipo ETDRS
    - Pacientes con capacidad y voluntad para seguir el protocolo del estudio y que otorguen su consentimiento informado
    E.4Principal exclusion criteria
    - Grade 5 ARMD
    - Have any ophthalmological disease that, based on the investigator judgment could interfere in the development, evolution or valoration of the ARMD, as glaucoma, permanent structural illness in the core of the fovea, para foveolar geographic atrophy, polipoideal carotids vasculitis, etc
    - Patients with concomitant illness that, based on the investigator judgment, could interfere (due to the disease itself or due to the associate treatment) in the development, evolution or evaluation of the ARMD, as diabetes mellitus with ocular affectation, active or ongoing systemic infection, any other ocular infection, psychiatric alterations, social situation which could interfere in the compliance with the study requirements and so on.
    - Received treatment in the previous month with any other intravetreal anti-VEGF drug in the last 3 months
    - Pregnant or breast- feeding
    - Pacientes con DMAE de 5º grado
    - Pacientes que presenten alguna patología ocular que, a juicio del investigador pueda influir en el desarrollo, evolución o valoración de la DMAE, como glaucoma, daños estructurales permanentes en el centro de la fóvea, atrofia geográfica parafoveolar, vasculopatía coroidea polipoidal, etc.
    - Pacientes con enfermedades concomitantes que, a juicio del investigador puedan influir (por la enfermedad en sí y/o sus tratamientos) en el desarrollo, evolución o valoración de la DMAE, como diabetes mellitus con afectación ocular, infección sistémica en curso o activa, cualquier infección ocular, trastornos psiquiátricos, situaciones sociales que puedan afectar al cumplimiento con los requisitos del estudio, etc.
    - Pacientes que hayan recibido tratamiento con algún fármaco anti-VEGF intravítreo en los últimos 3 meses.
    - Mujeres embarazadas o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Primary objective variable

    - Rate of success of treatment for patients in the 4 weeks after the intravitreal administration of etamsilato
    - Furthermore, if some requisites are fulfilled, the evolution, from the baseline visit up to week 4, of the best visual acuity corrected obtained with the ETDRS optptype and using logarithmic value (logMAR) equivalent to the number of letters correctly read, will be evaluated as co-principal criteria
    Criterio principal (para el objetivo principal):
    - Proporción de pacientes que presenten éxito del tratamiento en la semana 4 tras la administración intravítrea de etamsilato.
    - Además, si se cumplen ciertos requisitos se evaluará como criterio co-principal la Evolución desde la visita basal a la semana 4 de la mejor agudeza visual corregida determinada mediante el optotipo ETDRS y expresada en unidades logarítmicas decimales negativas del ángulo de resolución mínimo (logMAR) equivalentes al número de letras leídas correctamente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4-16 weeks
    4-16 semanas
    E.5.2Secondary end point(s)
    Secondary objective variable

    - Rate of success of treatment for patients in the week 16 after the intravitreal administration of etamsylate
    - Evolution, from the baseline visit up to week 16 of the best visual acuity corrected with the ETDRS optotype and using units logMAR equivalent to the total number of letters correctly read
    - Evolution, from the baseline visit up to week 4 and week 16, of the number of letters correctly read (counting from the upper left corner) with the ETDRS optotype
    - Evolution, from the baseline visit up to week 4 and week 16, of the best visual acuity corrected obtained with the Snellen optotype and using units logMAR adjusted to the total number of letters correctly read
    - Rate of success of treatment for patients at week 4 and at week 16 after the intravitreal administration of etamsylate
    - Rate of patients improving the visual acuity corrected more or equal to 15 letters with the ETDRS optptype.
    - Only for a subset of wet ARMD: Rate of patients with success of treatment and a decrease of the edema in the core of the macula, with a similar thickness in micro metres, at week 4 and at week 16.
    - Evolution of the thickness in the central part of the macula measured by OCT
    - Evolution of the number of focused areas of pigment epithelium disappearance measured with OCT
    - Evolution of the Scotoma size measured by micro perimetry
    - Evolution of the number, location, area and volume of the drusen measured by OCT and colored retinography.
    - Evolution of the sensitivity to contrast determined through Pelli-Robson tables
    - Evolution of patient quality of life measured with the Visual Function Questionnaire-25 of the National Eye Institute (VFQ-25) and the EuroQoL 5 dimensions (EQ-5D)
    Variables de los objetivos secundarios

    - Proporción de pacientes que presenten éxito del tratamiento en la semana 16 tras la administración intravítrea de etamsilato.
    - Evolución desde la visita basal a la semana 16 de la mejor agudeza visual corregida determinada mediante el optotipo ETDRS y expresada en unidades logMAR equivalentes al número de letras leídas correctamente.
    - Evolución desde la visita basal a la semana 4 y la semana 16 del número de letras leídas correctamente (contadas desde la esquina superior izquierda) en el optotipo ETDRS.
    - Evolución desde la visita basal a la semana 4 y la semana 16 de la mejor agudeza visual corregida determinada mediante el optotipo Snellen y expresada en unidades logMAR ajustadas al número total de letras leídas correctamente.
    - Proporción de pacientes que presentan respuesta al tratamiento en la semana 4 y en la semana 16 tras la administración intravítrea de etamsilato.
    - Proporción de pacientes que presentan una mejoría de la mejor agudeza visual corregida mayor o igual a 15 letras en el optotipo ETDRS.
    - Solamente para la submuestra de DMAE exudativa: proporción de pacientes que presentan éxito del tratamiento junto con disminución del edema de la parte central de la mácula, equiparado a su espesor en micrómetros, en la semana 4 y en la semana 16.
    - Evolución del grosor de la parte central de la mácula medido mediante tomografía de coherencia óptica (OCT).
    - Evolución del número de áreas focalizadas de desaparición del epitelio pigmentario de la retina medidas mediante OCT.
    - Evolución del tamaño del escotoma medido mediante microperimetría.
    - Evolución del número, localización, área y volumen de las drusas medido mediante OCT y retinografía en color.
    - Evolución de la sensibilidad al contraste determinado mediante tablas de Pelli-Robson
    - Evolución de la calidad de vida de los pacientes medida mediante el Cuestionario de la Función Visual-25 del National Eye Institute (VFQ-25) y el EuroQoL 5-Dimensiones (EQ-5D).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4-16 weeks
    4-16 semanas
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Tratamiento fingido
    Figured Treatment
    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
    LVLS
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state160
    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 Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-15
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