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    Summary
    EudraCT Number:2016-003870-41
    Sponsor's Protocol Code Number:EC_10/2016
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2017-01-05
    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 number2016-003870-41
    A.3Full title of the trial
    Comparison of treatment of diabetic macular edema with Ozurdex® versus Ozurdex® plus laser in areas of peripheral non-perfusion
    Comparación del tratamiento del edema macular diabético con Ozurdex® frente a Ozurdex® más láser en áreas de no perfusión periférica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of treatment of retinal macular inflammation due to diabetes with ozurdex or with ozurdex plus laser treatment in the area.
    Comparación de la eficacia del tratamiento de la inflamación macular retiniana debida a la diabetes con ozurdex o con ozurdex más tratamiento de láser en la zona.
    A.4.1Sponsor's protocol code numberEC_10/2016
    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 SponsorFundación para la Investigación Biomédica del Hospital Universitario Príncipe de Asturias
    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 supportAllergan
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Príncipe de Asturias
    B.5.2Functional name of contact pointCarolina Arruabarrena Sánchez
    B.5.3 Address:
    B.5.3.1Street Addresscrta. alcala-meco s/n
    B.5.3.2Town/ cityalcala de henares
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number+349188781002189
    B.5.6E-mailcarruabarrenas@gmail.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 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 nameOzurdex
    D.3.2Product code EMEA/H/C/001140
    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.3.9.2Current sponsor codeozurdex
    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
    retinal inflammation due to diabetes
    Inflamación retiniana debida a la diabetes
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    To compare the results of treatment of diabetic macular edema with Ozurdex® (sustained release dexamethasone implant) versus Ozurdex® plus selective photocoagulation of the areas of non-perfusion. We will compare both measured functional response and better corrected visual acuity, such as the anatomical response measured by optical coherence tomography (OCT) and the side effects of the treatment.
    Comparar los resultados del tratamiento del edema macular diabético con Ozurdex® (implante de liberación sostenida de dexametasona) frente a Ozurdex® más fotocoagulación selectiva de las áreas de no perfusión. Se comparará tanto la respuesta funcional medida como agudeza visual mejor corregida, como la respuesta anatómica medida por tomografía de coherencia óptica (OCT) y los efectos secundarios del tratamiento.
    E.2.2Secondary objectives of the trial
    To evaluate the changes in central macular thickness measured by OCT.
    To assess changes in macular volume as measured by OCT.
    Number of injections required in each group.
    Evaluar los cambios en el grosor central macular medido por OCT.
    Evaluar los cambios en el volumen macular medido por OCT.
    Número de inyecciones requeridas en cada grupo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with clinically significant diabetic macular edema with new diagnosis and peripheral ischemia
    AVMC between 23 and 75 letters
    Hb1ac <9
    Pseudophakic
    Over 18 years
    Pacientes con edema macular diabético clínicamente significativo de nuevo diagnóstico e isquemia periférica
    AVMC entre 23 y 75 letras
    Hb1ac <9
    Pseudofáquicos
    Mayores de 18 años
    E.4Principal exclusion criteria
    Previous history of glaucoma.
    Previous history of herpes eye infection.
    Prior history of vitrectomy.
    Previous therapeutic radiation near the eye region of the study
    Impossibility to perform fluorescein angiography.
    Inability to sign informed consent.
    Participation in a study with a research drug, biological product, or device within 30 days or duration of 5 half-lives of the investigational product (whichever is longer) prior to the start of the study Note: Studies that involve only over-the-counter vitamins, supplements, or diets are not included.
    Background of a medical disorder (disease, metabolic dysfunction, physical examination finding, clinical analytical finding) that, according to the investigator's opinion, would prevent scheduled study visits, study completion, or safe administration of the product under investigation.
    Any antecedent or evidence of concurrent intraocular disease in the eye of the study, such as retinal diseases other than EMD that, in the investigator's judgment, may require medical or surgical intervention during the course of the study to prevent or treat loss of acuity visual impairment that could result from that disease, or that limits the potential for visual acuity gain with treatment with the investigational product
    Historia previa de glaucoma.
    Historia previa de infección ocular por herpes.
    Historia previa de vitrectomía.
    Radiación terapéutica previa cerca de la región del ojo del estudio
    Imposibilidad de realizar angiografía fluoresceínica.
    Incapacidad para firmar el consentimiento informado.
    Participación en un estudio con un fármaco en investigación, producto biológico, o dispositivo en el plazo de 30 días o la duración de 5 semividas del producto en investigación (lo que sea más largo) antes del inicio del estudio Nota: No son excluyentes los estudios clínicos observacionales que impliquen únicamente vitaminas de venta sin receta, suplementos, o dietas
    Antecedentes de un trastorno médico (enfermedad, disfunción metabólica, hallazgo en la exploración física, hallazgo analítico clínico) que, según el criterio del investigador, impediría las visitas programadas del estudio, la conclusión del estudio, o una administración segura del producto en investigación
    Cualquier antecedente o evidencia de enfermedad intraocular concurrente en el ojo del estudio, tales como enfermedades de la retina diferente a EMD que, a juicio del investigador, podrían requerir la intervención médica o quirúrgica durante el transcurso del estudio para evitar o tratar la pérdida de agudeza visual que podría producirse por esa enfermedad, o que limite el potencial de ganancia de agudeza visual con el tratamiento con el producto en investigación
    E.5 End points
    E.5.1Primary end point(s)
    Corrected visual acuity measured with ETDRS after one year of treatment.
    Agudeza visual mejor corregida media medida con ETDRS al año de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Number of retreatments.
    Central foveal thickness as measured by OCT
    Macular volume measured by OCT
    Número de retratamientos.
    Grosor foveal central medido por OCT
    Volumen macular medido por OCT
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Fotocoagulación con laser
    Laser photocoagulation
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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
    The last visit of the last subject undergoing the trial
    Se considerará finalizado el ensayo cuando el último paciente aleatorizado haya completado la última visita del ensayo.
    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 months3
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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)
    The expected normal treatment of that condition
    Las condiicones normales de tratamiento según criterio clínico
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-30
    P. End of Trial
    P.End of Trial StatusRestarted
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