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    Summary
    EudraCT Number:2018-004785-33
    Sponsor's Protocol Code Number:CMO-MA-EYE-0603
    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:2019-04-11
    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 number2018-004785-33
    A.3Full title of the trial
    A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (according to standard clinical practice)  with Diabetic Macular Edema
    Estudio de 12 meses, prospectivo, abierto, de fase 4 para evaluar la eficacia y seguridad de OZURDEX® (implante intravítreo de dexametasona) en pacientes sin tratamiento previo (según la práctica clínica estándar) con edema macular diabetic
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of OZURDEX® in Treatment Naïve Patients with Diabetic Macular Edema
    Estudio para evaluar la eficacia y seguridad de OZURDEX® ) en pacientes sin tratamiento previo con edema macular diabetic
    A.3.2Name or abbreviated title of the trial where available
    EYEberia
    A.4.1Sponsor's protocol code numberCMO-MA-EYE-0603
    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 SponsorAllergan Pharmaceuticals International Limited
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Pharmaceuticals International Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Pharmaceuticals International Limited
    B.5.2Functional name of contact pointRachel Zaw
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, Parkway, Marlow
    B.5.3.2Town/ cityBuckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34636 459 439
    B.5.6E-mailrachel.zaw1@allergan.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 OZURDEX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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 nameOZURDEX®
    D.3.4Pharmaceutical form Intravitreal implant in applicator
    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 INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDexamethasone Intravitreal Implant
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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
    Diabetic Macular Edema
    Edema Macular Diabético
    E.1.1.1Medical condition in easily understood language
    Diabetic Macular Edema
    Edema Macular Diabético
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of OZURDEX in patients with DME when used in a real world setting in Spain and Portugal.
    El objetivo de este estudio es evaluar la eficacia y la seguridad de OZURDEX en pacientes con EMD cuando se utiliza en la vida real en España y Portugal.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 years of age
    2. Prior diagnosis of diabetes mellitus (type 1 or type 2)
    3. Presence of macular edema associated with diabetic retinopathy defined as macular thickening by optical coherence tomography (OCT) assessed by the investigator with the following characteristics:
    3.1. Involving the center of the macula (fovea)
    3.2. Visual acuity (VA) decrease attributable to macular edema
    4. Patients who are treatment naïve prior to enrollment in this study but have been prescribed OZURDEX by a physician. The prescribing information is at the discretion of the physician and reflects their standard of practice
    5. BCVA score between 20 and 70 letters (approximately 20/40 to 20/400 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the Baseline visit
    6. Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
    7. Women of childbearing potential should have a negative urine pregnancy test at the Baseline visit
    8. Written informed consent obtained in accordance with all local privacy requirements
    1. Hombres o mujeres de ≥ 18 años
    2. Diagnóstico previo de diabetes mellitus (de tipo 1 o tipo 2).
    3. Presencia de edema macular asociado a retinopatía diabética definido como un engrosamiento de la mácula mediante tomografía de coherencia óptica (TCO) evaluado por el investigador con las características siguientes:
    3.1. Afectación del centro de la mácula (fóvea)
    3.2. Disminución de la agudeza visual (AV) debida al edema macular
    4. Pacientes que no han recibido tratamiento antes de su inclusión en este estudio, pero a los que un médico ha recetado OZURDEX. La información sobre prescripción queda a criterio exclusivo del médico y refleja su práctica habitual
    5. Puntuación de la MAVC de entre 20-70 letras (aproximadamente 20/40 a 20/400 en la escala de Snellen) usando el método de estudio de tratamiento temprano de retinopatía diabética (ETDRS) en la visita inicial
    6. Claridad del medio, dilatación de la pupila y cooperación del paciente suficientes para todos los procedimientos del estudio
    7. Las mujeres en edad fértil se someterán a una prueba de embarazo en orina que debe ser negativa en la visita inicial
    8. Consentimiento informado por escrito obtenido conforme a todos los requisitos de privacidad locales
    E.4Principal exclusion criteria
    Investigators must refer to the Summary of Product Characteristics (SPC) for information on contraindications (Section 4.3), Warnings (Section 4.4), and Pregnancy and Lactation (Section 4.6).
    1. Uncontrolled systemic disease
    2. History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications
    3. Patients who have been previously treated for DME (use of two focal laser allowed)
    4. Presence of vitreomacular traction or pathology of epiretinal membrane that, in the opinion of the investigator, may significantly interfere with functional response to treatment
    5. Presence of anatomic biomarkers in OCT (disorganization of the retinal inner layers, damage of the ellipsoid zone) and OCT angiography (macular ischemia) that, in the opinion of the investigator, may significantly interfere with functional response to treatment
    6. Use of systemic corticosteroids within 1 month prior to Screening
    7. Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
    8. Elevated IOP or glaucoma diagnosis
    9. A substantial cataract is present that in the opinion of the investigator will need cataract surgery during the study and/or will not allow to perform imaging tests. ( If the patients is pseudophakic, cataract surgery was performed at least 3 months before recruitment in this study.
    10. Anticipated need for ocular surgery during the study
    11. History of vitrectomy or incisional glaucoma surgery
    12. Use of any intravenous steroid or intravitreal triamcinolone prior to Screening
    13. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
    14. Any condition that, in the opinion of the investigator, may interfere with follow up visits
    15. Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine
    Los investigadores deben consultar el resumen de las características del producto (RCP) para obtener información sobre contraindicaciones (sección 4.3), advertencias (sección 4.4) y embarazo y lactancia (sección 4.6)
    1. Enfermedad generalizada no resuelta
    2. Antecedentes de enfermedad, disfunción metabólica o resultados de análisis clínicos que hagan sospechar razonablemente que existe una enfermedad o afección que contraindiquen el uso del medicamento del estudio, que puedan afectar a la interpretación de los resultados del estudio o que puedan suponer un alto riesgo para el paciente de presentar complicaciones a causa del tratamiento
    3. Pacientes que han recibido tratamiento anterior para el EMD (se permite el uso de dos tratamientos focales con láser)
    4. Presencia de tracción vitreomacular o patología de membrana epirretiniana que, según la opinión del investigador, pueda interferir de manera significativa con la respuesta funcional al tratamiento
    5. Presencia de biomarcadores anatómicos en la TCO (desorganización de las capas retinianas interiores, daño en la zona elipsoide) y angiografía en la TCO (isquemia macular) que, según la opinión del investigador, pueda interferir de manera significativa con la respuesta funcional al tratamiento
    6. Uso de corticoesteroides sistémicos en el mes anterior a la selección
    7. Diabetes sin tratar o previsión de cambio (aumento) de la medicación contra la diabetes durante el estudio
    8. PIO elevada o diagnóstico de glaucoma
    9. Existe una catarata importante que, según la opinión del investigador, necesitará cirugía durante el estudio o no permitirá que se lleven a cabo pruebas de imagines. Si el paciente es pseudofáquico, la cirugía de cataratas se llevó a cabo al menos 3 meses antes del reclutamiento en el estudio
    10. Previsión de necesidad de cirugía ocular durante el estudio
    11. Haberse sometido con anterioridad a una vitrectomía o una cirugía incisional del glaucoma
    12. Uso de cualquier esteroide intravenoso o triamcinolona intravítrea antes de la selección
    13. Pacientes que estén embarazadas, en período de lactancia o que tengan intención de quedarse embarazadas o que sean fértiles y no estén usando un método anticonceptivo fiable
    14. Cualquier afección que, según la opinión del investigador, pueda interferir con las visitas de seguimiento
    15. Alergia, hipersensibilidad o contraindicación conocida a la medicación del estudio, sus componentes o a la yodopovidona
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in BCVA 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline
    Variación media en la mejor agudeza visual corregida (MAVC) 2 meses (±2 semanas) después de la última inyección recibida los meses 10 al 12 en comparación con los valores iniciales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mean change in best-corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline
    Variación media en la mejor agudeza visual corregida (MAVC) 2 meses (±2 semanas) después de la última inyección recibida los meses 10 al 12 en comparación con los valores iniciales.
    E.5.2Secondary end point(s)
    • Mean change from Baseline in CRT 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline
    • Mean retreatment interval
    • Mean number of injections administered during the 12- to 14-month study
    • AUC for CRT
    • AUC for BCVA
    • Mean change from Baseline in the NEI VFQ-25 at the Final Visit
    • Proportion of patients with 2nd injection during the study
    • Proportion of patients with 3rd injection during the study
    • Time to 2nd injection/time to 3rd injection
    Safety endpoints measured in this study include:
    • Nature, severity, and frequency of adverse events
    • Change in IOP
    • Cataract progression or development
    • Cardiovascular events during the treatment period
    • Variación media desde la visita inicial en el grosor retiniano central (GRC) 2 meses (±2 semanas) después de la última inyección recibida los meses 10 al 12 en comparación con los valores iniciales
    • Intervalo medio de repetición del tratamiento
    • Número medio de inyecciones administradas durante el estudio de 12 a 14 meses
    • Área bajo la curva (ABC) para el GRC
    • ABC para la MAVC
    • Variación media desde la visita inicial en el cuestionario sobre la función visual (VFQ)-25 del National Eye Institute (NEI) en la visita final
    • Proporción de pacientes con una 2ª inyección durante el estudio
    • Proporción de pacientes con una 3ª inyección durante el estudio
    • Tiempo hasta la 2ª inyección/tiempo hasta la 3ª inyección
    Los criterios de valoración de la seguridad de este estudio incluyen:
    • Naturaleza, gravedad y frecuencia de los acontecimientos adversos
    • Cambio en la presión intraocular (PIO)
    • Evolución o desarrollo de cataratas
    • Acontecimientos cardiovasculares durante el período de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Mean change from Baseline in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline
    • Mean retreatment interval
    • Mean number of injections administered during the 12- to 14-month study
    • Area under the curve (AUC) for CRT
    • AUC for BCVA
    • Mean change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ)-25 at the Final Visit
    • Proportion of patients with 2nd injection during the study
    • Proportion of patients with 3rd injection during the study
    • Time to 2nd injection/time to 3rd injection
    • Variación media desde la visita inicial en el grosor retiniano central (GRC) 2 meses (±2 semanas) después de la última inyección recibida los meses 10 al 12 en comparación con los valores iniciales
    • Intervalo medio de repetición del tratamiento
    • Número medio de inyecciones administradas durante el estudio de 12 a 14 meses
    • Área bajo la curva (ABC) para el GRC
    • ABC para la MAVC
    • Variación media desde la visita inicial en el cuestionario sobre la función visual (VFQ)-25 del National Eye Institute (NEI) en la visita final
    • Proporción de pacientes con una 2ª inyección durante el estudio
    • Proporción de pacientes con una 3ª inyección durante el estudio
    • Tiempo hasta la 2ª inyección/tiempo hasta la 3ª inyección
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Ultima Visita Ultimo 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-04
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