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    Summary
    EudraCT Number:2010-019795-74
    Sponsor's Protocol Code Number:CRFB002D2304
    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:2010-07-30
    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 number2010-019795-74
    A.3Full title of the trial
    "Estudio Fase IIIb aleatorizado de dos años, simple ciego, multicéntrico y controlado, para evaluar la eficacia y seguridad de 0,5 mg de ranibizumab en dos algoritmos de tratamiento de tipo "tratar y extender" frente a 0,5 mg de ranibizumab según necesidad, en pacientes con edema macular y discapacidad visual secundarios a diabetes mellitus." // "A 2 year randomized, single-masked, multicenter, controlled phase IIIb trial assessing the Efficacy and safety of 0.5 mg ranibizumab in two "treat and extend" treatment algorithms vs. 0.5 mg ranibizumab as needed in patients with macular edema and visual Impairment secondary to diabetes mellitus."
    A.3.2Name or abbreviated title of the trial where available
    RETAIN
    A.4.1Sponsor's protocol code numberCRFB002D2304
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 LUCENTIS 10 mg/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    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 nameLucentis
    D.3.2Product code RFB002D
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRANIBIZUMAB
    D.3.9.3Other descriptive nameRANIBIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Edema Macular Diabético (EDM) // Diabetic Macular Edema (DME)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que el cambio medio desde el valor basal de la MAVC a lo largo de un periodo de tratamiento de 12 meses obtenido con un régimen de tratamiento de tipo "tratar y extender" (TE) con 0,5 mg de ranibizumab más láser complementario, y/o con un régimen de tratamiento TE con 0,5 mg de ranibizumab solo, es por lo menos no inferior a 0,5 mg de ranibizumab solo administrado según necesidad (PRN) a pacientes con discapacidad visual debida a EMD, a fin de cubrir una posible declaración de superioridad. La condición para la interpretación de estos resultados es la evaluación de la extensión con la que se puedan mantener los regímenes de tratamiento TE durante el estudio.
    E.2.2Secondary objectives of the trial
    -Demostrar efecto estabilizador del láser complementario reflejado en un menor nº de visitas de estudio para tratamiento entre los meses 12 y 24, mediante comparación entre régimen de tratamiento TE con 0,5 mg de ranibizumab más láser complementario y régimen de tratamiento TE con 0,5 mg de ranibizumab solo.
    -Investigar eficacia del régimen de tratamiento TE con 0,5 mg de ranibizumab más láser complementario, régimen de tratamiento TE con 0,5 mg de ranibizumab solo y 0,5 mg de ranibizumab solo administrado a demanda sobre el funcionamiento relacionado con la visión y el bienestar evaluados durante 12 meses, en su medición mediante puntuación en los cuestionarios VFQ-25 y EQ-5D.
    -Comparar cambios en el grosor de la retina central y grosor del subcampo central obtenidos a lo largo del tiempo con el régimen de tratamiento TE con 0,5 mg de ranibizumab más láser complementario, el régimen de tratamiento TE con 0,5 mg de ranibizumab solo y 0,5 mg de ranibizumab solo administrado a demanda.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Del paciente:
    1. Hombres y mujeres >18 años de edad que hayan firmado un consentimiento informado.
    2. Pacientes con diabetes mellitus de tipo 1 ó 2 (de acuerdo con las directrices de la American Diabetes Association o la Organización Mundial de la Salud [OMS]), con una hemoglobina glucosilada (HbA1c) </= 12,0% en la selección (visita 1). Los pacientes deben estar siguiendo una dieta, un plan de ejercicio y/o un tratamiento farmacológico para la diabetes. El tratamiento de la diabetes debe haberse mantenido estable durante un mínimo de 3 meses.
    Oculares:
    3. Pacientes con discapacidad visual debida a EMD por lo menos en un ojo que sean elegibles para tratamiento con láser en opinión del investigador. Si ambos ojos son elegibles, el investigador seleccionará como ojo en estudio aquel con peor agudeza visual en la evaluación de la visita 1.
    4. MAVC >/=39 y </=78 letras en el ojo en estudio, mediante el uso de optotipos ETDRS (Estudio del tratamiento precoz de la retinopatía diabética) a una distancia de examen de 4 metros (que equivale aproximadamente a un resultado con optotipos de Snellen de 20/32 a 20/160) en el momento de la selección.
    5. Procesos concomitantes en el ojo en estudio que, en opinión del investigador, no impidan una mejoría de la agudeza visual durante el tratamiento del estudio.
    E.4Principal exclusion criteria
    1. Lesión estructural dentro de 0,5 diámetro de disco del centro macular del ojo en estudio que probablemente vaya a impedir una mejoría de la agudeza visual tras la resolución del edema macular, lo que incluye atrofia del epitelio pigmentario retiniano, fibrosis subretiniana, cicatrices de láser, membrana epirretiniana que afecte a la fóvea o placas de exudados duros organizadas.
    Tratamientos oculares previos:
    2. Toda cirugía intraocular en el ojo en estudio en el plazo de los 3 meses anteriores a la aleatorización.
    3. Antecedentes de vitrectomía en el ojo en estudio, independientemente del tiempo transcurrido hasta la aleatorización.
    4. Intervención médica o quirúrgica prevista durante el periodo de estudio de 24 meses.
    5. Fotocoagulación con láser panretiniana en el ojo en estudio en el plazo de los 6 meses anteriores a la aleatorización.
    6. Fotocoagulación con láser focal/en rejilla en el ojo en estudio en el plazo de los 3 meses anteriores a la aleatorización.
    7. Tratamiento con medicamentos antiangiógenicos en el ojo en estudio (pegaptanib sódico, acetato de anecortave, bevacizumab, ranibizumab, VEGF-Trap, etc.) en el plazo de los 3 meses anteriores a la aleatorización.
    8. Uso de otros medicamentos en investigación en el momento del reclutamiento, o en el plazo de 3 meses o 5 semividas antes del reclutamiento, eligiéndose el periodo más largo.
    9. Antecedentes de tratamiento con corticosteroides intravítreos en el ojo en estudio fáquico.
    10. Corticosteroides intravítreos en un ojo en estudio intervenido de catarata (afáquico o pseudofáquico, sin lesión de la cápsula posterior) en el plazo de los 3 meses anteriores a la aleatorización.
    11. Procesos oculares en el ojo en estudio que precisen un tratamiento concomitante crónico con corticosteroides de administración ocular tópica o sistémica.
    Enfermedades o tratamientos sistémicos:
    12. Antecedentes de ictus en el plazo de los 6 meses anteriores al reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal será la diferencia entre el nivel promedio de la MAVC (letras) en todas las evaluaciones mensuales post-basales desde el mes 1 hasta el mes 12 y el nivel basal de la MAVC. La última medición recogida antes del inicio del tratamiento será considerada como nivel basal.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ranibizumab/fotocoagulación láser
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Cuando el último paciente haya completado la visita de seguimiento de la Visita 26 (Mes 24), (última visita del último paciente LPLV).
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 313
    F.4.2.2In the whole clinical trial 345
    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)
    Current clinical practice
    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 Decision2010-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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