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    Summary
    EudraCT Number:2011-002859-34
    Sponsor's Protocol Code Number:CRFB002E2402
    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 number2011-002859-34
    A.3Full title of the trial
    A 24-month, phase IIIb, open-label, randomized, activecontrolled, 3-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 or with adjunctive laser photocoagulation in comparison to laser photocoagulation in patients with visual impairment due to macular edema
    secondary to branch retinal vein occlusion (BRVO)
    ?Estudio de 24 meses, de fase IIIb, multicéntrico, abierto, aleatorizado, con control activo, de 3 grupos de tratamiento para evaluar 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 o con fotocoagulación con láser adyuvante comparado con fotocoagulación con láser en pacientes con afectación visual debida a edema macular secundario a oclusión de rama venosa de la retina (ORVR).?
    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
    BRIGHTER
    BRIGHTER
    A.4.1Sponsor's protocol code numberCRFB002E2402
    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 codeRFB002
    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 branch retinal occlusion (BRVO)
    pacientes con afectación visual debida a edema
    macular secundario a oclusión de rama venosa de la retina (ORVR)
    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
    La afectacion visual causadas 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 10038907
    E.1.2Term Retinal vein occlusion
    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.1.3Condition 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 demonstrate that an individualized stabilization-criteria-driven PRN dosing regimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive laser treatment has superior efficacy as compared to the current standard of care, laser photocoagulation, in patients with visual impairment due to ME secondary to BRVO. The primary objective will be assessed by the mean BCVA change at Month 6 compared to Baseline.
    Demostrar que una pauta posológica individualizada a demanda según criterios
    definidos de estabilización, con 0,5 mg de ranibizumab administrados con o sin
    tratamiento adyuvante con láser tiene mayor eficacia comparada con el tratamiento
    de referencia actual, la fotocoagulación con láser, en pacientes con afectación visual
    debida a EM secundaria a ORVR. El objetivo principal se evaluará mediante el
    cambio de la mejor agudeza visual corregida (MAVC) media en el mes 6, en
    comparación con la visita inicial.
    E.2.2Secondary objectives of the trial
    To demonstrate in a first step that treatment with ranibizumab with adjunctive laser is noninferior
    to treatment with ranibizumab monotherapy as assessed by the mean average BCVA change from Month 1 through Month 24 compared to Baseline. To demonstrate in a second step (after demonstrating non-inferiority) that ranibizumab with adjunctive laser reduces the number of ranibizumab retreatments as compared to ranibizumab monotherapy by assessing the number of ranibizumab treatments applied up to Month 23.
    Demostrar en un primer paso que el tratamiento con ranibizumab con láser
    adyuvante no es inferior al tratamiento con monoterapia con ranibizumab, según se
    evalúa mediante el promedio del cambio medio en la MAVC desde el mes 1 hasta el
    mes 24, en comparación con el valor inicial. Para demostrar en un segundo paso
    (después de demostrar la no inferioridad) que el ranibizumab con láser adyuvante
    reduce el número de repeticiones de tratamiento con ranibizumab, en comparación
    con la monoterapia con ranibizumab, evaluando el número de tratamientos de
    ranibizumab aplicados hasta el mes 23.
    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 ?18 years of age
    ? Diagnosis of visual impairment exclusively due to ME secondary to BRVO
    ? BCVA score at Screening and Baseline between 73 and 19 letters Early
    Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen
    chart equivalent of 20/40 and 20/400)
    ? Antes de llevar a cabo ninguna evaluación del estudio, debe obtenerse el consentimiento informado por escrito.
    ? Pacientes (de ambos sexos de) ? 18 años
    ? Diagnóstico de afectación visual debido exclusivamente a EM secundario a ORVR
    ? Puntuación de la MAVC en la selección y en la visita inicial entre 73 y 19 letras del Estudio del Tratamiento Temprano de la Retinopatía Diabética (ETDRS), inclusive (que equivale aproximadamente a 20/40 y 20/400 en el optotipo de Snellen)
    E.4Principal exclusion criteria
    ? Pregnant or nursing (lactating) women
    ? Stroke or myocardial infarction less than 3 months before 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 must 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 while on medication or according to investigator?s judgment) at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
    ? Neovascularization of the iris or neovascular glaucoma in the study eye
    ? Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
    ? Treatment (or anticipated treatment in the fellow eye for non-RVO indications during the study) with any anti-angiogenic drugs (including any anti-VEGF agents) within 3 months before Baseline in either eye (eg, pegaptanib [Macugen®], ranibizumab [Lucentis®], bevacizumab [Avastin®])
    ? Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
    ? Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
    ? Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
    ? Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye
    ?Mujeres embarazadas o lactantes (o en periodo de lactancia)
    ?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. Puede iniciarse un tratamiento antihipertensivo que deberá tomarse durante al menos 30 días, después de los cuales el paciente puede ser evaluado por segunda vez para determinar si es apto para el estudio
    ?Cualquier infección o inflamación periocular u ocular activa (por ejemplo, blefaritis, conjuntivitis, queratitis, escleritis, uveítis, endoftalmitis) en el momento de la selección o en la visita inicial en cualquiera de los 2 ojos
    ?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 en cualquiera de los 2 ojos
    ?Neovascularización del iris o glaucoma neovascular en el ojo del estudio
    ?Uso de cualquier fármaco sistémico contra el factor de crecimiento endotelial vascular (anti-VEGF) en los seis meses anteriores a la visita inicial (por ejemplo, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
    ?Tratamiento (o tratamiento previsto en el ojo contralateral para indicaciones distinta de OVR durante el estudio) con algún fármaco antiangiógeno (incluido cualquier fármaco anti-VEGF) en los 3 meses anteriores a la visita inicial en cualquiera de los 2 ojos (por ejemplo, pegaptanib [Macugen®], ranibizumab [Lucentis®], bevacizumab [Avastin®])
    ?Fotocoagulación panretiniana con láser en los 3 meses anteriores a la visita inicial o prevista o programada en los 3 meses siguientes a la visita inicial en el ojo del estudio
    ?Fotocoagulación con láser focal o en rejilla en los 4 meses anteriores a la visita inicial en el ojo del estudio
    ?Uso de corticoesteroides intraoculares o perioculares (incluidos subcapsulares [bajo la cápsula de Tenon]) en los 3 meses anteriores a la selección en el ojo del estudio
    ?El uso de cualquier implante de corticoesteroide intraocular (por ejemplo, dexametasona [Ozurdex®], acetónido de fluocinolona [Iluvien®]) en el ojo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the mean BCVA change at Month 6 compared to Baseline in patients with visual impairment due to ME secondary to BRVO.
    La variable principal es el promedio del cambio medio en la MAVC en el mes 6 en comparación con la visita inicial en pacientes con afectación visual debida a EM secundario a ORVR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Month 6
    A mes 6
    E.5.2Secondary end point(s)
    ? The mean average change in BCVA from Month 1 through Month 24 compared to Baseline
    ? The number of ranibizumab treatments
    ? The mean average change in BCVA from Month 1 through Month 6 compared to Baseline
    ? The mean change in BCVA from Baseline up to Month 12 and Month 24, by visit
    ? The mean average change in BCVA from the time point of the first treatment interruption (due to BCVA stabilization) for all following visits until End of Study
    ? The mean change in BCVA from the time point of the first treatment interruption (due to BCVA stabilization) assessed on a monthly basis until End of Study
    ? The number and proportion of patients with a BCVA gain of ?1, ?5, ?10, ?15, and ?30 letters / loss of <15 letters from Baseline up to Month 6 and Month 24, by visit
    ? The number and proportion of patients with a BCVA value ?73 letters (20/40 Snellen equivalent) from Baseline up to Month 6 and Month 24, by visit
    ? The mean average BCVA change from the time point of first ranibizumab treatment for all following visits until End of Study in patients randomized to laser
    ? The mean change in CRC-assessed CSFT from Baseline up to Month 6 and Month 24, by visit
    ? The mean change in patient reported outcomes in NEI-VFQ-25 score (composite score
    and subscales) at Month 6 and Month 24 compared to Baseline
    ?el promedio del cambio medio en la MAVC desde el mes 1 hasta el mes 24 en comparación con la visita inicial
    ?El número de tratamientos con ranibizumab
    ?el promedio del cambio medio en la MAVC desde el mes 1 hasta el mes 6 en comparación con la visita inicial
    ?el promedio del cambio medio en la MAVC desde el mes 1 hasta el mes 24 por visita
    ?el cambio medio en la MAVC desde el punto temporal de la primera interrupción del tratamiento (si se debió a la estabilización de la MAVC) de forma mensual hasta el final del estudio
    ?Evaluar el promedio del cambio medio en la MAVC desde el punto temporal de la interrupción del primer tratamiento (si se debió a la estabilización de la MAVC) para todas las visitas siguientes hasta el final del estudio
    porcentaje de pacientes que alcanzan una mejoría en la MAVCMAVC de ? 1, ? 5, ? 10, ? 15 y ?30 letras y el porcentaje de pacientes que experimentan una pérdida de <15 letras desde la visita inicial hasta el mes 6 y mes 24 por visita
    - evaluación de la proporción de pacientes que alcanzan valores de MAVC? 73 letras (equivalente aproximado a 20/40 de Snellen) de visita inicial hasta el mes 6 y mes 24 por visita
    ?Evaluar el cambio medio en la MAVC desde el punto temporal de la primera interrupción del tratamiento (si se debió a la estabilización de la MAVC) de forma mensual hasta el final del estudio en los pacientes aleatorizados a tratamiento con monoterapia con ranibizumab o con láser adyuvante
    ?Evaluar el cambio medio en el CST evaluado por el CRC a partir del mes 1 y hasta el mes 12 y el mes 24 en comparación con la visita inicial
    ?Evaluar los resultados referidos por el paciente en el mes 12 y el mes 24 en comparación con la visita inicial según la puntuación y las subescalas compuestas del NEI-VFQ-25 por grupo de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Month 1 through Month 24
    de mes 1 hasta mes 24
    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 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 Yes
    E.8.1.6Cross over Yes
    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
    Fotocoagulación con láser
    Laser photocoagulation
    E.8.2.4Number of treatment arms in the trial3
    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 No
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 315
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 450
    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
    P.Date of the global end of the trial2015-05-27
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