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    Summary
    EudraCT Number:2017-000250-19
    Sponsor's Protocol Code Number:CADODIAME
    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:2017-04-07
    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 number2017-000250-19
    A.3Full title of the trial
    Effect of calcium dobesilate in early stages of diabetic retinopathy
    Efecto del dobesilato de calcio en estadios precoces de retinopatía diabética
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of calcium dobesilate in early stages of diabetic retinopathy
    Efecto del dobesilato de calcio en estadios precoces de retinopatía diabética
    A.3.2Name or abbreviated title of the trial where available
    CADODIAME
    CADODIAME
    A.4.1Sponsor's protocol code numberCADODIAME
    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 SponsorFundació Hospital Universitari Vall d'Hebron - Institut de Recersa (VHIR)
    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 supportVIFOR OM PHARMA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d'Hebron - Institut de Recersa (VHIR)
    B.5.2Functional name of contact pointRafael Simó
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d’Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number34934894172
    B.5.6E-mailrafael.simo@vhir.org
    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 Doxium 500
    D.2.1.1.2Name of the Marketing Authorisation holderOM PHARMA S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameCalcium dobesilate monohydrate
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXIUM
    D.3.9.3Other descriptive nameCALCIUM DOBESILATE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB11768MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic retinopathy
    Retinopatía diabética
    E.1.1.1Medical condition in easily understood language
    Diabetic retinopathy
    Retinopatía diabética
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10012689
    E.1.2Term Diabetic retinopathy
    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 determine whether Doxium® is able to prevent or reduce thickening of the retina.
    Determinar si Doxium® es capaz de prevenir o reducir el engrosamiento de la retina.
    E.2.2Secondary objectives of the trial
    • To assess whether Doxium® is able to slow the progression of subclinical diabetic macular edema (DME) to clinically significant DME.
    • To determine whether Doxium® is able to slow the progression of diabetic retinopathy assessed by ETDRS (≥ 1 level).
    • To assess whether Doxium® is able to slow the progression of neurodegenerative changes.
    • To evaluate whether Doxium® is able to slow the reduction of visual acuity.
    • To predict whether Doxium® is able to slow the progression of foveal microvascular changes.
    • To examine potential changes in the morphology and function of the choroid.
    • To assess the safety of Doxium®, including adverse events, serious adverse events, analytical data and vital signs.
    •Evaluar si Doxium® es capaz de frenar la progresión del edema macular diabético (EMD) subclinico a un EMD clínicamente significativo.
    •Determinar si Doxium® es capaz de frenar la progresión de la retinopatía diabética evaluada por ETDRS (≥ 1 nivel).
    •Evaluar si Doxium® es capaz de frenar la progresión de los cambios neurodegenerativos.
    •Evaluar si Doxium® es capaz de frenar la reducción de la agudeza visual.
    •Evaular si Doxium® es capaz de frenar la progresión de los cambios microvasculares en la fóvea.
    •Examinar los potenciales cambios en la morfología y función de la coroides.
    •Evaluar la seguridad de Doxium®, incluidos acontecimientos adversos, acontecimientos adversos graves, datos analíticos y constantes vitales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with type 2 diabetes mellitus.
    • Subclinical diabetic macular edema.
    • ETDRS score 20-47.
    • Duration of diabetes ≥ 5 years.
    • Age between 45 and 70 years (both included)
    • HbA1c ≥7% and ≤8.5% in the previous 6 months and at screening.
    •Pacientes con diabetes mellitus tipo 2.
    •Edema macular diabético subclínico.
    •Puntuación ETDRS 20-47.
    •Duración de la diabetes ≥ 5 años.
    •Edad entre 45 y 70 años (ambos incluidos)
    •HbA1c ≥7% y ≤8.5% en los 6 meses previos y al screening.
    E.4Principal exclusion criteria
    • Medical record of laser photocoagulation.
    • Presence of any retinal disease other than diabetic retinopathy.
    • Patients with a refractive error of ≥5 diopters in one of the two eyes.
    • Pupillary dilation or any eye defect that does not allow good quality images of fundus.
    • Medical record of ocular surgery in the 6 months prior to randomization.
    • Advanced chronic kidney disease (≥ stage 4).
    •known Allergy or intolerance ti IMP
    •Pregnancy or child-bearing age women that don't accept or can't use anticonceptive methodes during all the study
    •Patients that cannot follow the study indications
    •Use of an IMP within the last 30 days prior to screening visit
    •Antecedentes de fotocoagulación con láser.
    •Presencia de alguna enfermedad de la retina que no sea la retinopatía diabética.
    •Pacientes con un defecto de refracción de ≥5 dioptrías en uno de los dos ojos.
    •Dilatación pupilar o cualquier defecto ocular que no permita obtener imágenes del fondo de ojo de buena calidad.
    •Antecedente de cirugía ocular en los 6 meses previos a la randomización.
    •Enfermedad renal crónica avanzada (≥ estadío 4).
    • Alergia o intolerancia conocida al producto de investigación.
    • Mujeres embarazadas o mujeres fértiles que no acepten o no puedan usar un método anticonceptivo aceptable durante todo el período del ensayo.
    • Pacientes que se prevé que no serán capaces de seguir las indicaciones del estudio
    • Uso de un fármaco en investigación en los 30 días previos a la visita de screening.
    E.5 End points
    E.5.1Primary end point(s)
    The increase in retinal thickness measured by SD-OCT from the beginning to the end of the study.
    El incremento del grosor de la retina medido por SD-OCT desde el inicio hasta el final del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 months, 4 months, 8 months and 12 months
    0 meses, 4 meses, 8 meses y 12 meses
    E.5.2Secondary end point(s)
    - The severity of diabetic retinopathy measured with the ETDRS scale.
    - Retinal nerve fiber layer measured with OCT.
    - The layer of ganglion cells measured with OCT.
    - Visual acuity on the ETDRS scale.
    - Foveal microvessels changes evaulated by anti-OCT.
    - Choroidal anomalies assessed by OCT.
    - Safety, including adverse effects and laboratory results.
    - La severidad de la retinopatía diabética medida con la escala ETDRS.
    - La capa de fibras nerviosas de la retina medida con OCT.
    - La capa de células ganglionares medida con OCT.
    - Agudeza visual por la escala ETDRS.
    - Cambios en los microvasos foveales evaulado por antiografía-OCT.
    - Anomalias coroidales valorado por OCT.
    - Seguridad, incluidos los efectos adversos y resultados de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the endpoint the timepoint will be different: 0 months, 4 months, 8 months and 12 months
    Dependiendo de la variable, el momento de evaluación puede ser
    diferente:0 meses, 4 meses, 8 meses y 12 meses
    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 No
    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 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 Yes
    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
    LVLS
    UVUP
    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 months0
    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: 60
    F.1.3Elderly (>=65 years) No
    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 state60
    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 Decision2017-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-24
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