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    Summary
    EudraCT Number:2011-002350-31
    Sponsor's Protocol Code Number:CRFB002E2401
    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:2011-11-29
    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 number2011-002350-31
    A.3Full title of the trial
    A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)
    Estudio de 24 meses, fase IIIb, multicéntrico, abierto, de un único grupo de tratamiento que evalúa la eficacia y la seguridad de una pauta posológica individualizada a demanda según criterios definidos de estabilización, con inyecciones intravítreas de 0,5 mg de ranibizumab aplicadas como monoterapia en pacientes con afectación visual debida a edema macular secundario a oclusión de vena central de la retina (OVCR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eye
    Tratamiento con ranibizumab de deterioro visual causado por oclusión
    de los vasos (venas) que llevan a la inflamación de la retina en la parte
    posterior del ojo
    A.3.2Name or abbreviated title of the trial where available
    CRYSTAL
    CRYSTAL
    A.4.1Sponsor's protocol code numberCRFB002E2401
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointMarie Hanssen
    B.5.3 Address:
    B.5.3.1Street Address3900 Paramount Parkway
    B.5.3.2Town/ cityMorrisville NC
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1919 561 3005
    B.5.5Fax number+1919 654 9184
    B.5.6E-mailMarie.Hanssen@ppdi.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 LUCENTIS
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameLUCENTIS
    D.3.2Product code RFB002E
    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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.2Current sponsor codeRFBOO2
    D.3.9.3Other descriptive nameRANIBIZUMAB
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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 Yes
    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
    visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)
    afectación visual debida a edema macular secundario a oclusión de vena central de la retina (OVCR).
    E.1.1.1Medical condition in easily understood language
    visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eye
    los problemas visuales causados por los vasos ocluidos (venas) que
    llevan a la inflamación de la retina en la parte posterior del ojo
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10025415
    E.1.2Term Macular oedema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10047571
    E.1.2Term Visual impairment
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10007972
    E.1.2Term Central retinal vein occlusion
    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
    The primary objective is to evaluate the efficacy of an individualized stabilization criteria-driven
    PRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean BCVA change
    at Month 12 compared to Baseline.
    El objetivo principal es evaluar la eficacia de una pauta posológica individualizada a demanda según criterios definidos de estabilización, con 0,5 mg de ranibizumab, según su evaluación de acuerdo con el cambio promedio de mejor agudeza visual corregida (MAVC) en el mes 12 en comparación con la visita inicial.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of PRN dosing of 0.5-mg ranibizumab injections as assessed by:
    ? the mean change in BCVA
    ? the mean average change in BCVA
    ? the proportion of patients achieving:
    - BCVA improvement of ?1, ?5, ?10, ?15, and ?30 letters
    - reaching BCVA values of ?73 letters (approximate 20/40 Snellen chart equivalent)
    - with a BCVA loss of <15 letters
    ? the mean change in central reading center (CRC)-assessed central subfield thickness (CSFT)
    ? the patient-reported outcomes by the NEI-VFQ-25 composite score and subscales
    To evaluate the mean average change in BCVA from the timepoint of the first treatment interruption (if due to BCVA stabilization)
    To evaluate the mean change in BCVA by visit from the timepoint of the first treatment interruption (if due to BCVA stabilization)
    To evaluate the safety of ranibizumab injections as assessed by the type, frequency, and severity of ocular and non-ocular AEs
    Evaluar la eficacia de la administración a demanda de inyecciones de 0,5 mg de ranibizumab, según la evaluación mediante:
    ?cambio promedio en MAVC
    ?cambio promedio medio en MAVC
    ?% de pacientes que alcanza una mejora del MAVC de ? 1, ? 5, ? 10, ? 15 y ? 30 letras
    ?% de pacientes que alcanza valores de MAVC de ? 73 letras
    ?% de pacientes con una pérdida de MAVC de < 15 letras
    ?cambio promedio en el espesor del subcampo central (CST)
    ?resultados comunicados por el paciente en los meses 12 y 24
    ?Evaluar el cambio promedio medio en MAVC a partir del punto temporal de la 1ª interrupción del tratamiento
    ?Evaluar el cambio medio en MAVC por visita a partir del punto temporal de la 1ª interrupción del tratamiento
    ?Evaluar la seguridad de las inyecciones de ranibizumab, evaluadas mediante el tipo, la frecuencia y la gravedad de los AA oculares y no oculares
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent must be obtained before any study assessment is performed- Male or female patients must be at least 18 years of age
    - Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein occlusion (CRVO)
    - Best-corrected visual acuity at Screening and Baseline must be between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400)

    Other protocol-defined inclusion criteria may apply
    1. Antes de llevar a cabo ninguna evaluación del estudio, debe
    obtenerse el consentimiento informado por escrito.
    2. Los pacientes de uno u otro sexo deben tener al menos 18 años de
    edad
    3. Diagnóstico de afectación visual debida exclusivamente a EM
    secundario a oclusión de vena central de la retina (OVCR)
    4. La mejor agudeza visual corregida en la selección y la visita inicial
    debe estar entre las 73 y las 19 letras del estudio del tratamiento
    temprano de la retinopatía diabética (ETDRS) inclusive (que equivale
    aproximadamente a 20/40 y 20/400 en la gráfica de Snellen)
    Otro scriterios de inclusion descritos en el protocolo pueden aplicar.
    E.4Principal exclusion criteria
    ? Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
    ? Stroke or myocardial infarction less than 3 months prior to Screening
    ? Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline. Antihypertensive treatment can be initiated and has to be taken for at least 30 days after which the patient can be assessed for study eligibility a second time
    ? Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
    ? Uncontrolled glaucoma (intraocular pressure [IOP] ?30 mm Hg on medication or according to investigator?s judgment) at Screening or Baseline or diagnosed within 6 months prior to Baseline in either eye
    ? Neovascularization of the iris or neovascular glaucoma in either eye
    ? Use of any systemic anti-vascular endothelial growth factor (VEGF) drugs within 6 months prior to Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
    ? Prior treatment with any anti-angiogenic drugs (including any anti-VEGF agents) within 3 months prior to Baseline in either eye (eg, pegaptanib [Macugen®], ranibizumab [Lucentis®], bevacizumab [Avastin®])
    ? Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
    ? Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye
    ? Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months prior to Screening in the study eye
    ? Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

    Other protocol-defined exclusion criteria may apply
    -Mujeres embarazadas o en período de lactancia, donde el embarazo se
    define como el estado de una mujer después de la concepción y hasta
    que se ha completado la gestación, confirmado mediante un resultado
    positivo en una prueba de laboratorio de gonadotropina coriónica
    humana (GCH)
    - Infarto cerebral o de miocardio en los 3 meses anteriores a la selección
    - Tensión arterial no controlada que se define como un valor sistólico de
    > 160 mm Hg o un valor diastólico de > 100 mm Hg en la selección o en
    la visita inicial. Los valores se medirán 3 veces utilizando un dispositivo
    validado con un manguito de la medida adecuada. La repetición de
    mediciones en sedestación se hará en intervalos de 1 a 2 minutos y se
    utilizará la media de las 3 mediciones. El tratamiento antihipertensor
    puede iniciarse y debe tomarse durante al menos 30 días, después de los
    cuales el paciente puede ser evaluado por segunda vez para ver si es
    apto para el estudio.
    - Cualquier infección o inflamación periocular u ocular activa (por
    ejemplo, blefaritis, conjuntivitis, queratitis, escleritis, uveitis,
    endoftalmitis) en la selección o en la visita inicial
    - Glaucoma no controlado (presión intraocular [PIO] ? 30 mm Hg con
    medicación o según el criterio del investigador) en la selección o la visita
    inicial, o diagnosticado en los 6 meses anteriores a la visita inicial
    -Neovascularización de iris o glaucoma neovascular
    -Uso de algún fármaco sistémico contra el VEGF en los 6 meses
    anteriores a la visita inicial (por ejemplo, sorafenib [Nexavar®],
    sunitinib [Sutent®], bevacizumab [Avastin®])
    - 22. Tratamiento (o tratamiento previsto en el ojo contralateral para
    indicaciones que no son OVR durante el estudio) con algún fármaco
    antiangiogénico (incluido cualquier agente contra el VEGF) en los 3
    meses anteriores a la visita inicial en uno u otro ojo (por ejemplo,
    pegaptanib [Macugen®], ranibizumab [Lucentis®], bevacizumab
    [Avastin®]).
    - Fotocoagulación panretiniana por láser en los 3 meses antes de la
    visita inicial, o bien prevista o programada en los 3 meses siguientes a la
    visita inicial
    - Fotocoagulación con láser focal o en rejilla en los 4 meses anteriores a
    la visita inicial
    -Uso de corticoesteroides intra o perioculares (incluido de forma
    subcapsular [bajo la cápsula de Tenon]) en los 3 meses anteriores a la
    selección
    - Todo uso de corticoesteroides intraoculares (por ejemplo,
    dexametasona [Ozurdex®], acetónido de fluocinolona [Iluvien®])
    Otros criterios de exclusion definidos en el protocolo tambien pueden
    aplicar.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the mean change in BCVA at Month 12 compared to
    Baseline.
    La variable principal de eficacia es el cambio promedio en MAVC en el
    mes 12 en comparación con la visita inicial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Month 12 compared to Baseline.
    en el mes 12 en comparación con la visita inicial
    E.5.2Secondary end point(s)
    The following secondary efficacy endpoints will be evaluated for the study eye:
    ? the mean change in BCVA from Month 1 through Month 24 compared to Baseline, by visit
    ? the mean change in BCVA from Month the timepoint of the first treatment interruption (due to BCVA stabilization) through Month 24, by visit
    ? the mean average change in BCVA from Month 1 through Month 12 and from Month 1 through Month 24 compared to Baseline
    ? the mean average change in BCVA from the timepoint of the first treatment interruption (due to BCVA stabilization) through Month 12 and/or Month 24
    ? the number and proportion of patients with a BCVA improvement of ?1, ?5, ?10, ?15, and ?30 letters from Baseline to Month 12 and Month 24, by visit
    ? the number and proportion of patients with a BCVA value of ?73 letters (approximate 20/40 Snellen chart equivalent) at Month 12 and Month 24, by visit
    ? the number and proportion of patients with a BCVA loss of <15 letters from Baseline up to Month 12 and Month 24, by visit
    ? the mean change in CRC-assessed CSFT from Month 1 through Month 12 and Month 24 compared to Baseline
    ? the mean change in patient-reported outcomes in NEI-VFQ-25 score (composite score and subscales) at Month 12 and Month 24 compared to Baseline
    Se evaluaran los siguientes criterios de valoración secundarios de
    eficacia:
    ?el cambio promedio en MAVC a partir del mes 1 hasta el mes 24 en
    comparación con la visita inicial
    ?el cambio promedio medio en MAVC a partir del mes 1 y hasta los
    meses 12 y 24 en comparación con la visita inicial
    ?el porcentaje de pacientes que alcanza una mejora del MAVC de ? 1, ?
    5, ? 10, ? 15 y ? 30 letras con respecto a la visita inicial hasta los meses
    12 y 24
    ?el porcentaje de pacientes que alcanza valores de MAVC de ? 73 letras
    (que equivale aproximadamente a 20/40 en la gráfica de Snellen) en los
    meses 12 y 24
    ?el porcentaje de pacientes con una pérdida de MAVC de < 15 letras a
    partir del valor inicial, hasta los meses 12 y 24
    ?el cambio promedio en el espesor del subcampo central (CST), evaluado
    por el centro de lectura central (CRC) a partir del mes 1 y hasta los
    meses 12 y 24 en comparación con la visita inicial
    ?los resultados comunicados por el paciente en los meses 12 y 24 en
    comparación con la visita inicial según la puntuación y las subescalas
    compuestas del NEI-VFQ-25
    E.5.2.1Timepoint(s) of evaluation of this end point
    from Month 1 through Month 12 and from Month 1 through Month 24 compared to Baseline
    a partir del mes de 1 a 12 meses y del mes 1 hasta el mes 24 respecto al
    valor 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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Greece
    Hungary
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days20
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 245
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 350
    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)
    Standar Care
    Tratamiento habitual
    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 Decision2012-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-09
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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