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    Summary
    EudraCT Number:2020-003987-22
    Sponsor's Protocol Code Number:GT-ORACLE
    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:2022-10-21
    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 number2020-003987-22
    A.3Full title of the trial
    ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study.
    ORACLE: Estudio de seguimiento a largo plazo para evaluar la seguridad y durabilidad de GT005 en participantes con atrofia geográfica secundaria a la degeneración macular relacionada con la edad, tratados en un estudio anterior patrocinado por Gyroscope
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the long term safety of GT005 in participants having macular degeneration that led to geographic atrophy in their eyes and that have been previously treated in a prior Gyroscope study using the same product.
    Estudio para evaluar la seguridad a largo plazo de GT005 en participantes con degeneración macular que les produjo atrofia geográfica en los ojos y que han sido tratados en un estudio previo de Gyroscope con el mismo producto
    A.3.2Name or abbreviated title of the trial where available
    GT-ORACLE
    GT-ORACLE
    A.4.1Sponsor's protocol code numberGT-ORACLE
    A.5.4Other Identifiers
    Name:EudraCT NumberNumber:2020-003987-22
    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 SponsorGyroscope Therapeutics Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportGyroscope Therapeutics Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccovion S.L.
    B.5.2Functional name of contact pointMonica Reale
    B.5.3 Address:
    B.5.3.1Street AddressC/ O’Donnell, 12 4a planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34657 316 821
    B.5.6E-maileuclinicaltrials@clinipace.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.3.2Product code GT005
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubretinal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone
    D.3.9.1CAS number None
    D.3.9.2Current sponsor codeGT005
    D.3.9.3Other descriptive nameGT005
    D.3.9.4EV Substance CodeSUB215825
    D.3.10 Strength
    D.3.10.1Concentration unit Vector genome
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2000000000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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
    Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in participants already treated with GT005 in the GT005-02 (EXPLORE) and GT005-03 (HORIZON) antecedent studies.
    Atrofia geográfica (AG) secundaria a la degeneración macular asociada a la edad (DMAE) en participantes ya tratados con GT005 en los estudios previos GT005-02 (EXPLORE) y GT005-03 (HORIZON).
    E.1.1.1Medical condition in easily understood language
    Geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a progressive disease that results in a blurred area or blank spot in the centre of vision, and very common in elderly.
    LA AG secundaria a la degeneración macular asociada a la edad (DMAE), una enfermedad progresiva que da lugar a una zona borrosa/una mancha en blanco, en el centro de la visión, frecuente en mayores.
    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 LLT
    E.1.2Classification code 10075719
    E.1.2Term Atrophic age-related macular degeneration
    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
    The overall objectives of the study are to evaluate the long-term safety and durability of GT005 in participants with GA secondary to AMD who have been treated in an antecedent study. The primary endpoint of this study (GT-ORACLE) is to evaluate the long-term safety of GT005 for up to 5 years post-treatment, evaluating the incidence and severity of ocular and systemic adverse events (AEs).
    Los objetivos generales del estudio son evaluar la seguridad y la durabilidad a largo plazo de GT005 en participantes con AG secundaria a DMAE que hayan sido tratados en un estudio anterior. El objetivo principal de este estudio (GT-ORACLE) es evaluar la seguridad a largo plazo de GT005 hasta 5 años después del tratamiento, evaluando la incidencia y la gravedad de los acontecimientos adversos (EA) oculares y sistémicos.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term durability of GT005 on GA progression.
    To evaluate the long-term durability of GT005 on functional measures.
    Evaluar la durabilidad a largo plazo de GT005 en la progresión de la AG.
    Evaluar la durabilidad a largo plazo de GT005 en las medidas funcionales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to give written informed consent
    2. Received GT005 in an antecedent study, GT005-02 (EXPLORE, NCT04437368 and GT005-03 (HORIZON, NCT04566445)
    3. Willing to attend study visits and complete the study procedures.
    1. Capaz y dispuesto a dar su consentimiento informado por escrito
    2. Haber recibido GT005 en un estudio anterior, GT005-02 (EXPLORE, NCT04437368 y GT005-03 (HORIZON, NCT04566445)
    3. Estar dispuesto a asistir a las visitas del estudio y completar los procedimientos del mismo.
    E.4Principal exclusion criteria
    Not Applicable. If the participant is not able to attend Week 96 visit (End of Study visit for antecedent study) due to personal or medical reasons, the Sponsor should be consulted, and participant asked to attend the Study Centre at their next available opportunity to complete the Visit 1 for the ORACLE study.
    No aplicable. Si el participante no puede asistir a la visita de la semana 96 (visita de fin de estudio para el estudio antecedente) debido a razones personales o médicas, se debe consultar al promotor y pedir al participante que asista al centro de estudio cuando le sea posible para completar la visita 1 del estudio ORACLE.
    E.5 End points
    E.5.1Primary end point(s)
    Primary: Incidence and severity of ocular and systemic adverse events (AEs)
    Primario: Incidencia y gravedad de los acontecimientos adversos (AA) oculares y sistémicos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants in this follow-up study will be evaluated for 3 years (a total duration of 5 years post-GT005 administration in the antecedent study).
    Los participantes en este estudio de seguimiento serán evaluados durante 3 años (una duración total de 5 años tras la administración de GT005 en el estudio anterior).
    E.5.2Secondary end point(s)
    • Change from baseline (pre-administration of GT005) in GA area as measured by fundus autofluorescence (FAF)
    • Change from baseline (pre-administration of GT005) in best corrected visual acuity (BCVA) via early
    treatment diabetic retinopathy study (ETDRS) chart
    - Cambio con respecto a la valor inicial (antes de la administración de GT005) en el área de la AG medida por autofluorescencia del fondo de ojo (AFO)
    - Cambio con respecto al valor inicial (antes de la administración de GT005) en la agudeza visual mejor corregida (AVMC) mediante el optotipo de estudio de retinopatía diabética de tratamiento temprano (ETDRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Participants in this follow-up study will be evaluated for 3 years (a total duration of 5 years post-GT005 administration in an antecedent study).
    Los participantes en este estudio de seguimiento serán evaluados durante 3 años (una duración total de 5 años tras la administración de GT005 en un estudio previo)
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    Estudio de seguimiento a largo plazo para determinar la seguridad y durabilidad del GT005 de dos EC
    Long-Term Follow Up study to determine safety and durability of GT005 of two Phase II Clinical Trial
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Yes
    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
    United States
    France
    Poland
    Netherlands
    Spain
    Germany
    Ireland
    United Kingdom
    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
    This long-term follow-up study will consist of up to five study visits for up to a 5-year period: Visit 1 (Week 96 post-GT005 administration) should coincide with the final visit in the antecedent study; Visit 2 (Week 126 post-GT005 administration); Visit 3 (Week 156/3 years post-GT005 administration); Visit 4 (Week 208/4 years post-GT005 administration) and Visit 5 (Week 260/5 years post-GT005 administration).
    Este estudio de seguimiento a largo plazo consistirá en un máximo de cinco visitas de estudio durante un período máximo de 5 años: Visita 1 (semana 96 tras la administración del GT005) debe coincidir con la visita final del estudio anterior; la visita 2 (semana 126 tras la administración del GT005); la visita 3 (semana 156/3 años tras la administración del GT005); la visita 4 (semana 208/4 años tras la administración del GT005) y la visita 5 (semana 260/5 años tras la administración del GT005).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 200
    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 end of the study will be defined as the last visit by the last participant. All participants will be followed, post-study, as per normal standard of care for their disease, and at the discretion of their physician.
    El final del estudio se definirá como la última visita del último participante. Todos los participantes serán seguidos, después del estudio, según la práctica clínica habitual para su enfermedad, y a discreción de su médico.
    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 Decision2023-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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