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    Summary
    EudraCT Number:2014-000107-27
    Sponsor's Protocol Code Number:GX29176
    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:2014-12-16
    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 number2014-000107-27
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION
    ESTUDIO DE FASE III MULTICÉNTRICO, RANDOMIZADO, CON DOBLE ENMASCARAMIENTO, CONTROLADO CON SIMULACIÓN, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LAMPALIZUMAB ADMINISTRADO EN INYECCIÓN INTRAVÍTREA A PACIENTES CON ATROFIA GEOGRÁFICA SECUNDARIA A DEGENERACIÓN MACULAR RELACIONADA CON LA EDAD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (Study #1)
    Estudio que investiga la eficacia y seguridad de Lampalizumab administrado en inyección intravítrea en pacientes con atrofia geográfica secundaria a degeneración macular relacionada con la edad.
    A.3.2Name or abbreviated title of the trial where available
    Chroma
    A.4.1Sponsor's protocol code numberGX29176
    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 SponsorRoche Farma S.A en nombre de F. Hoffmann-La Roche Ltd
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@roche.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 No
    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 nameLampalizumab
    D.3.2Product code Ro5490249/F03- 01
    D.3.4Pharmaceutical form Lyophilisate for 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 INNLampalizumab
    D.3.9.1CAS number 1278466-20-8
    D.3.9.2Current sponsor codeRO5490249
    D.3.9.3Other descriptive nameFCFD4514S, Anti-Factor D, AFD
    D.3.9.4EV Substance CodeSUB167278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typeantigen-binding fragment (Fab) of a humanized monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboIntravitreal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Geographic atrophy
    Atrofia geográfica
    E.1.1.1Medical condition in easily understood language
    Geographic atrophy
    Atrofia geográfica
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10063947
    E.1.2Term Geographic atrophy
    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 evaluate the efficacy and safety of 10 mg lampalizumab intravitreal injections of administered every 4 weeks (Q4W) or every 6 weeks (Q6W) in patients compared with sham control assessed by change in the geographic atrophy (GA) area from baseline as measured by fundus autofluorescence (FAF).
    En este estudio se evaluará la eficacia y la seguridad de 10 mg de lampalizumab administrado en inyección intravítrea cada 4 semanas (C4S) o cada 6 semanas (C6S), en comparación con el tratamiento control simulado,en comparación con el tratamiento control simulado, que se valorará basándose en el cambio producido en el área de la AG respecto al estado basal, medido en FAF.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of lampalizumab compared with sham control with the use of secondary assessments BCVA, microperimetry, reading charts and patient reported questionnaires.
    Evaluar el efecto de lampalizumab comparado con el tratamiento control simulado con respecto a la mejor agudeza visual corregida, evaluada mediante las cartillas de lectura y cuestionarios del paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Willingness to provide signed informed consent; additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws
    - Participants aged >/= 50 years
    Ocular Inclusion Criteria: Study Eye
    - Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV)
    - BCVA of 20/100 or better (Snellen equivalente) using ETDRS charst at starting distance of 4 m
    -If BCVA is superior or equal to 20/25, at least one GA lesion must be within 250 micrometers of the foveal centre
    - Disposición para otorgar el consentimiento informado firmado. Además, en los centros de EE.UU., los pacientes deben proporcionar la autorización de la Health Insurance Portability and Accountability Act (HIPAA) y en otros países, las autorizaciones que sean pertinentes de acuerdo con las leyes nacionales.
    - Tener >/=50 años de edad
    Criterios de inclusión oculares: Ojo en estudio
    - Área o áreas bien delimitadas de AG secundaria a DMAE, sin evidencia de NVC previa o activa
    - MAVC de 20/100 o mejor (en equivalentes de Snellen) utilizando cartillas ETDRS a una distancia inicial de 4 m
    - Si MAVC es ?20/25, como mínimo una lesión de AG debe estar en 250 µm del centro de la fóvea
    E.4Principal exclusion criteria
    GA Characteristics Exclusion Criteria
    - GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
    Ocular Exclusion Criteria: Study Eye
    History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
    - Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
    - Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy
    - History of prophylactic subthreshold laser treatment for AMD
    - Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.
    Ocular Exclusion Criteria: Non-study eye
    - Non-functioning non-study eye defined as either:
    BCVA of hand motion or worse or no physical presence of non-study eye (i.e. monocular)
    Ocular Exclusion Criteria: Both Eyes
    - Previous treatment with eculizumab or participation in eculizumab studies
    - Previous treatment of either eye with lampalizumab
    - Previous treatment with fenretinide or participation in fenretinide studies

    Concurrent Systemic Conditions Exclusion Criteria
    - Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or
    diastolic >110 mm Hg while patient is sitting) If a patient's initial
    measurement exceeds these values, a second reading may be taken 30
    or more minutes later. If the patient's blood pressure must be
    controlled by anti hypertensive medication, the patient can become
    eligible if medication is taken continuously for at least 30 days prior to
    Day 1.
    - History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
    - Treatment for active systemic infection
    - Predisposition or history of increased risk of infection
    - Active malignancy
    - History of allergy to fluorescein that is not amenable to treatment
    - History of a severe allergic reaction or anaphylactic reaction to a
    biologic agent or known hypersensitivity to any component of the
    lampalizumab injection
    - Inability to comply with study or follow-up procedures
    - Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed
    and graded by the central reading center
    - Previous participation in any studies of investigational drugs within 3 months preceding Day 1 (excluding vitamins and minerals)
    Criterios de exclusión relacionados con las características de la AG
    - AG en cualquiera de los dos ojos por causas distintas a DMAE (distrofias maculares monogenéticas [p. ej. enfermedad de Stargardt, distrofia de conos y bastones] o maculopatías tóxicas [p. ej. maculopatía por cloroquina/hidroxicloroquina
    - Criterios de exclusión oculares: Ojo en estudio
    Vitrectomía, cirugía submacular u otras intervenciones quirúrgicas previas para la DMAE
    -Fotocoagulación con láser previa para NVC, antecedentes de edema macular diabético, oclusión de la vena retiniana y retinopatía diabética proliferativa.
    -Tratamiento previo con Visudyne?, radioterapia de haz externo o termoterapia transpupilar
    -Tratamiento profiláctico previo para DMAE con láser subumbral
    - Intervención farmacológica o procedimiento intravítreo previos (p. ej. administración de inyecciones de corticosteroides, fármacos antiangiogénicos, agentes anticomplemento o implantación de dispositivos por vía intravítrea). Está permitida la administración intraoperatoria de una dosis única de un corticosteroide durante la cirugía de cataratas para la profilaxis del edema macular cistoide, como mínimo 3 meses antes del período de selección.

    Criterios de exclusión oculares: Ojo no en estudio
    - No funcionamiento del ojo no en estudio definido como:
    MAVC del movimiento de la mano o peor o no presencia física del ojo no en estudio (es decir, monocular)

    Criterios de exclusión oculares: Ambos ojos
    -Tratamiento previo con eculizumab o participación en estudios de eculizumab
    -Tratamiento previo con lampalizumab en cualquiera de los dos ojos
    -Tratamiento previo con fenretinida o participación en estudios de fenretinida

    Criterios de exclusión oculares: Patologías oculares concomitantes
    - Presión arterial no controlada (que se define como presión sistólica > 180 mm Hg y/o diastólica > 110 mm Hg mientras el paciente está sentado)
    Si la medición inicial excede de estos valores, se puede realizar una segunda toma al cabo de ? 30 minutos. Los pacientes que precisen medicación antihipertensiva para el control de la presión arterial pueden ser elegibles para el estudio si han tomado la medicación de forma continua como mínimo durante los 30 días anteriores al día 1
    -Antecedentes de otras enfermedades, alteraciones metabólicas, hallazgos de la exploración física o de laboratorio clínico que lleven a sospechar razonablemente la presencia de una enfermedad o trastorno que contraindicarían el uso de lampalizumab o que podrían afectar a la interpretación de los resultados del estudio o que supondrían para el paciente un riesgo alto de complicaciones relacionadas con el tratamiento
    - Tratamiento para infecciones sistémicas activas
    - Predisposición a un mayor riesgo de infecciones
    - Neoplasias malignas activas
    - Antecedentes de alergia a fluoresceína que no responde a tratamiento
    - Historia de una reacción alérgica grave o reacción anafiláctica a un agente biológico o hipersensibilidad conocida a cualquier componente de la inyección lampalizumab
    - Incapacidad para cumplir los procedimientos del estudio o el seguimiento
    - Incapacidad para obtener CFP e imágenes en FAF y AF de calidad adecuada para que puedan ser analizadas y clasificadas por el centro de interpretación central
    - Participación previa en cualquier estudio con fármacos experimentales en los 3 meses previos al día 1 (exceptuando los estudios de vitaminas o minerales)
    E.5 End points
    E.5.1Primary end point(s)
    Change in GA area, as assessed by fundus autofluorescence (FAF)
    Cambio en el área de AG, respecto la autofluorescencia del fondo de ojo
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 48
    Desde la basal a la semana 48
    E.5.2Secondary end point(s)
    - Change in best corrected visual acuity (BCVA), as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 m
    - Change in BCVA, as assessed by the ETDRS chart (at a starting distance of 4 m) under low luminance conditions

    Safety:
    - Incidence of adverse events relative to sham
    - Proportion of patients with confirmed anti-therapeutic antibodies directed against lampalizumab
    -Mejor agudeza visual corregida (MAVC), evaluada utilizando la cartilla del Early Treatment Diabetic Retinopathy Study (ETDRS) (a una distancia inicial de 4 m)
    -MAVC, evaluada utilizando la cartilla ETDRS (a una distancia inicial de 4 m) en condiciones de baja luminosidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to 2 years
    Desde la basal hasta los 2 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial8
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Denmark
    France
    Germany
    Hungary
    Italy
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Russian Federation
    Slovakia
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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 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: 187
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 749
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 346
    F.4.2.2In the whole clinical trial 936
    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 Sponsor will offer post-study access to the study drug lampalizumab free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to IMPs.
    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 Decision2014-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-29
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