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    Summary
    EudraCT Number:2020-004427-16
    Sponsor's Protocol Code Number:GR40549
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-20
    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 number2020-004427-16
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (PORTAL)
    ESTUDIO DE EXTENSIÓN ABIERTO, MULTICÉNTRICO PARA EVALUAR LA SEGURIDAD Y TOLERABILIDAD A LARGO PLAZO DEL DISPOSITIVO PORT DELIVERY SYSTEM CON RANIBIZUMAB EN PACIENTES CON DEGENERACIÓN MACULAR ASOCIADA A LA EDAD NEOVASCULAR (PORTAL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Long-Term Safety and Tolerability of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration (Portal)
    Estudio para evaluar la seguridad y tolerabilidad a largo plazo del dispositivo Port Delivery System con ranibizumab en pacientes con degeneración macular asociada a la edad (PORTAL)
    A.4.1Sponsor's protocol code numberGR40549
    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. U. que realiza el ensayo en España y que actúa como representante 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.Hoffman-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. Hoffman-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 nameRANIBIZUMAB
    D.3.2Product code RO4893594
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular 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.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    Neovascular Age-Related Macular Degeneration (nAMD)
    Degeneración macular asociada a la edad neovascular (DMAEn)
    E.1.1.1Medical condition in easily understood language
    AMD is an eye disease that impacts the central area of the retina in the eye. Neovascular AMD, is a serious type of AMD that causes vision loss due to abnormal blood vessel growth.
    DMAE es una enfermedad ocular que afecta la zona central de la retina del ojo.La DMAEneovascular es un tipo grave de DMAE que provoca pérdida de visión por el crecimiento anormal de vasos sanguíneos
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    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
    To evaluate the long-term safety and tolerability of ranibizumab delivered via the Port Delivery System with ranibizumab (PDS) every 24 weeks (Q24W) or every 36 weeks (Q36W) with the 100 mg/mL formulation
    Evaluar la seguridad y tolerabilidad a largo plazo de ranibizumab administrado a través del dispositivo portal delivery sistem (PDS) cada 24 semanas (C24S) o cada 36 semanas (C36S) utilizando la formulación de 100 mg/ml
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of ranibizumab delivered via the PDS Q24W or Q36W with the 100 mg/mL formulation, as assessed by visual acuity
    - To evaluate the efficacy of ranibizumab, delivered via the PDS Q24W or Q36W with the 100-mg/mL formulation, as assessed by center point thickness (CPT) on optical coherence tomography (OCT)
    - To evaluate the proportion of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg
    - Evaluar la eficacia de ranibizumab administrado a través del dispositivo PDS C24S o C36S utilizando la formulación de 100 mg/ml, basándose en la agudeza visual
    - Evaluar la eficacia de ranibizumab administrado a través del dispositivo PDS C24S o C36S utilizando la formulación de 100 mg/ml, basándose en el grosor del punto central (GPC) medido en tomografía de coherencia óptica (OCT)
    - Evaluar el porcentaje de pacientes que reciben tratamiento complementario con inyecciones intravítreas de 0,5 mg de ranibizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study (monthly intravitreal ranibizumab 0.5 mg or implant arms) OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
    - Ability and willingness to undertake all scheduled visits and assessments
    - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
    - Haber participado y completado previamente los estudios GX28228 (Ladder) o GR40548 (Archway), sin haber terminado prematuramente el tratamiento ni haber sido retirados de estos estudios (pacientes de los grupos tratados con inyecciones intravítreas mensuales de 0,5 mg de ranibizumab o el implante) O haber sido incluidos previamente en el estudio WR42221 (Velodrome) y no ser elegibles para ser aleatorizados en ese estudio en la semana 24, o haber completado el estudio (pacientes de los grupos C24S o C36S)
    - Tener capacidad y disposición para realizar todas las visitas y evaluaciones planificadas
    - Las mujeres deben practicar la abstinencia sexual (abstenerse de mantener relaciones heterosexuales) o usar métodos anticonceptivos durante el período de tratamiento y como mínimo hasta 28 días después de la última inyección intravítrea de ranibizumab y hasta 1 año después de la última recarga-intercambio del implante con ranibizumab.
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
    - History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
    - History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
    - Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"
    - Mujeres embarazadas, en período de lactancia o que tengan intención de quedarse embarazadas durante el período de tratamiento y, como mínimo, hasta 28 días después de la última inyección intravítrea de ranibizumab o hasta 1 año después de la última recarga-intercambio del implante con ranibizumab
    - Antecedentes de otras enfermedades oculares que lleven a sospechar razonablemente la presencia de una enfermedad o trastorno que contraindiquen el uso de ranibizumab y que pudieran afectar a la interpretación de los resultados del estudio o suponer para el paciente un riesgo alto de complicaciones relacionadas con el tratamiento
    - Antecedentes de otras enfermedades, alteraciones metabólicas o hallazgos de laboratorio clínico que lleven a sospechar razonablemente la presencia de una enfermedad o trastorno que contraindiquen el uso de ranibizumab o la inserción del implante y que pudieran afectar a la interpretación de los resultados del estudio o suponer para el paciente un riesgo alto de complicaciones relacionadas con el tratamiento
    - Necesidad de utilizar de forma continua cualquiera de las medicaciones o tratamientos indicados en la sección del protocolo correspondiente a terapia no permitida
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of ocular and systemic (non-ocular) adverse events (AEs)
    2. Incidence, severity, and duration of adverse event of special interest (AESIs)
    3. Incidence, severity, and duration of ocular AESIs during the postoperative period (up to 37 days of initial implantation) and follow-up period (>37 days after implantation surgery) for patients who receive the implant in the study
    4. Incidence and severity of adverse device effects
    5. Incidence, causality, severity, and duration of anticipated serious adverse device effects
    1. Incidencia e intensidad de los acontecimientos adversos (AA) oculares y sistémicos (no oculares)
    2. Incidencia, intensidad y duración de los acontecimientos adversos de especial interés (AESIs).
    3. Incidencia, severidad y duración de los AESIs oculares durante el período postoperatorio (hasta 37 días después del implante inicial) y el período de seguimiento (> 37 días después de la cirugía del implante) en los pacientes que reciban el implante en el estudio
    4. Incidencia e intensidad de los efectos adversos relacionados con el dispositivo
    5. Incidencia, causalidad, intensidad y duración de los efectos adversos graves previstos relacionados con el dispositivo
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-5. Up to Week 144
    1-5 hasta la semana 144
    E.5.2Secondary end point(s)
    1. Change in best-corrected visual acuity (BCVA) score from baseline over time, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters
    2. Percentage of patients who lose < 15, < 10, or < 5 letters in BCVA score from baseline over time
    3. Percentage of patients with BCVA score of 38 letters (of 20/200 approximate Snellen equivalent) or worse over time
    4. Percentage of patients with BCVA score of 69 letters (20/40 approximate Snellen equivalent) or better over time
    5. Change from baseline in CPT over time
    6. Percentage of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg during each refill-exchange interval
    1. Cambio en la puntuación de la mejor agudeza visual corregida (MAVC) respecto al estado basal en el transcurso del tiempo, evaluado en una cartilla de agudeza visual Early Treatment Diabetic Retinopathy Study (ETDRS) a una distancia inicial de 4 metros
    2. Porcentaje de pacientes con pérdida de <15, <10 o <5 letras en la puntuación de la MAVC respecto al estado basal, en el transcurso del tiempo
    3. Porcentaje de pacientes con puntuación de la MAVC de 38 letras (aproximadamente 20/200 en equivalentes de Snellen) o peor, en el transcurso del tiempo
    4. Porcentaje de pacientes con puntuación de la MAVC de 69 letras (aproximadamente 20/40 en equivalentes de Snellen) o mejor, en el transcurso del tiempo
    5. Cambio en el valor de CST respecto al estado basal en el transcurso del tiempo
    6. Porcentaje de pacientes que reciben tratamiento complementario con inyecciones intravítreas de 0,5 mg de ranibizumab durante cada intervalo de recarga-intercambio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline to Week 144
    2-4. Up to Week 144
    5. Baseline to Week 144
    6. Weeks 16 to Week 136
    1. momento basal a la semana 144
    2-4. hasta la semana 144
    5. momento basal a la semana 144
    6. semanas 16 a la semana 136
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarkers, exploratory patient experience
    Tolerabilidad, biomarcadores , experiencia exploratoria del paciente
    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 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 Yes
    E.8.1.7.1Other trial design description
    Pacientes que han completado fase II GX28228 , fase III GR40548, fase IIIb WR42221 o completado S24
    Patients completed Phase II GX28228 , Phase III GR40548, Phase IIIb WR42221 or completed W24
    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.8.2.4Number of treatment arms in the trial7
    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 concerned11
    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
    Australia
    Brazil
    Canada
    Israel
    Korea, Republic of
    Singapore
    Taiwan
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    Argentina
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days12
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 890
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 1035
    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 terminate the trial once Ranibizumab becomes commercially available. Currently, the Sponsor does not have any plans to provide Ranibizumab to patients who have completed the study. The Sponsor may evaluate whether to continue providing Ranibizumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website: http://www.roche.com/policy_continued_access_to_investigational_ medicines.pdf
    El promotor pondrá fin al ensayo una vez que ranibizumab esté disponible en el mercado.Actualmente,el promotor no tiene planes de proporcionar Ranibizumab a los pacientes que hayan completado el estudio. El promotor podrá evaluar si continúa proporcionando Ranibizumab de acuerdo con la Política Global de Roche sobre el Acceso Continuado a los Medicamentos en Investigación está disponible en el siguiente sitio web:http://www.roche.com/policy_continued_access_to_investigational_ medicines.pdf
    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 Decision2021-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-22
    P. End of Trial
    P.End of Trial StatusOngoing
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