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    Summary
    EudraCT Number:2019-003421-22
    Sponsor's Protocol Code Number:GT005-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 number2019-003421-22
    A.3Full title of the trial
    EXPLORE: A phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration
    EXPLORE: Estudio de fase 2, con enmascaramiento para el evaluador de los resultados, multicéntrico y aleatorizado para evaluar la seguridad y la eficacia de dos dosis de GT005 administradas en una única inyección subretiniana en sujetos con atrofia geográfica secundaria a la 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 to test the safety and effect of a treatment for people with sight loss due to dry Age-related Macular Degeneration
    Estudio para evaluar la seguridad y el efecto de un tratamiento en personas con pérdida de visión debida a degeneración macular seca asociada a la edad.
    A.4.1Sponsor's protocol code numberGT005-02
    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
    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
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGyroscope Therapeutics
    B.5.2Functional name of contact pointAlex Bloom
    B.5.3 Address:
    B.5.3.1Street AddressGunnels Wood Road, Stevenage Bioscience Catalyst,
    B.5.3.2Town/ cityStevenage, Hertfordshire
    B.5.3.3Post codeSG1 2FX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441438906770
    B.5.6E-maila.bloom@gyroscopetx.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 nameRecombinant, non-replicating AAV2 expressing human CFI
    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 CodeSUB195182
    D.3.10 Strength
    D.3.10.1Concentration unit vector genomes (vg)/mL
    D.3.10.2Concentration typeequal
    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 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
    Age-related Macular Degeneration (AMD) presents as a progressive loss of vision in the centre of the retina (the macula) resulting in a blurred area or blank spot in the centre of vision. The primary clinical characteristic of late stage AMD is atrophy of the Retinal Pigment Epithelium, known as macular atrophy due to AMD, which leads to the gradual degeneration of nearby photoreceptors, resulting in thinning of the retina and a progressive visual impairment.
    DMAE se manifiesta como una pérdida progresiva de visión en el centro de la retina (la mácula) que origina una zona borrosa o una mancha en blanco en el centro de la visión. La característica clínica principal de la DMAE en fase avanzada es la atrofia del epitelio pigmentario de la retina, conocida como atrofia macular debida a DMAE, que origina una degeneración gradual de los fotorreceptores cercanos, lo que produce un adelgazamiento de la retina y un deterioro visual progresivo.
    E.1.1.1Medical condition in easily understood language
    Age-related Macular Degeneration (AMD) presents as a progressive loss of vision in the centre of the retina (the macula) resulting in a blurred area or blank spot in the centre of vision.
    DMAE se manifiesta como una pérdida progresiva de visión en el centro de la retina (la mácula) que origina una zona borrosa o una mancha en blanco en el centro de la visión.
    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 safety and efficacy (anatomical and functional visual outcomes) of two doses of GT005 in genetically defined subjects with GA due to AMD.

    Primary objective:
    To evaluate the effect of GT005 on the progression of GA in subjects with GA due to AMD
    Los objetivos generales del estudio son evaluar la seguridad y la eficacia (parámetros anatómicos y visuales funcionales) de dos dosis de GT005 en pacientes con AG debida a DMAE definidos genéticamente.

    Principal:
    Evaluar el efecto de GT005 sobre la progresión de la AG en pacientes con AG debida a DMAE
    E.2.2Secondary objectives of the trial
    Secondary:
    - To evaluate the safety and tolerability of GT005.
    - To evaluate the effect of GT005 on retinal anatomical measures.
    - To evaluate the effect of GT005 on functional measures.
    - To evaluate the effect of GT005 on functional vision.
    - To evaluate the effect of GT005 on patient-reported outcomes.

    Exploratory:
    - To evaluate complement factor expression and activation.
    - To evaluate immunogenicity of GT005.
    - To evaluate biomarkers of AMD.
    Secundarios
    - Evaluar la seguridad y la tolerabilidad de GT005.
    - Evaluar el efecto de GT005 sobre las mediciones anatómicas de la retina.
    - Evaluar el efecto de GT005 sobre las medidas funcionale.
    - Evaluar el efecto de GT005 sobre la visión functional.
    - Evaluar el efecto de GT005 sobre los resultados comunicados por los pacientes.

    Exploratorios:
    - Evaluar la expresión y activación de factores del complement.
    - Evaluar la inmunogenicidad de GT005.
    - Evaluar los biomarcadores de la DMAE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to give written informed consent
    2. Age ≥18 years
    3. Have a clinical diagnosis of GA secondary to AMD as determined by the Investigator
    4. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye
    5. The GA lesion in the study eye must reside completely within the FAF image
    6. Have a BCVA of 34 letters (6/60 and 20/200 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
    7. Serum CFI level less than the lower limit of the normal range (11.6 to 35.7 mcg/mL) on an Enzyme-linked immunosorbent assay
    8. Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
    9. Able to attend all study visits and complete the study procedures
    10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation
    1. Capacidad y disposición para otorgar el consentimiento informado por escrito
    2. Edad ≥18 años
    3. Tener un diagnóstico clínico de AG secundaria a DMAE según lo determinado por el investigador
    4. Tener un tamaño total de las lesiones de AG igual o superior a 1,25 mm2 y hasta 17,5 mm2 en el ojo en estudio
    5. La lesión de AG en el ojo en estudio debe estar completamente dentro de la imagen de AFF
    6. Tener una MAVC de 34 letras (equivalente de agudeza de Snellen de 6/60 y 20/200) o mejor, utilizando los optotipos del ETDRS, en el ojo en estudio
    7. Concentración plasmática de FIC por debajo del límite inferior del intervalo normal (11,6 a 35,7 µg/ml) en un ensayo de inmunosorbente ligado a enzimas
    8. Presencia de una variante genética rara del gen del FIC, definida como una frecuencia alélica menor <1 %.
    9. Capacidad para acudir a todas las visitas del estudio y someterse a los procedimientos del estudio
    10. Las mujeres potencialmente fértiles deberán tener una prueba de embarazo negativa en las 2 semanas previas a la aleatorización
    E.4Principal exclusion criteria
    1. Have evidence or history of CNV or diabetic retinopathy in either eye
    2. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
    3. Have clinically significant cataract that may require surgery during the study period in the study eye
    4. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
    5. Have a contraindication to oral prednisolone/prednisone
    6. Have participated in another research study involving an investigational product in the previous 12 weeks, or five half-lives, whichever is longer, or received a gene or cell therapy at any time
    7. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
    8. Have a history or presence of cutaneous squamous cell carcinoma
    1. Signos o antecedentes de NVC o retinopatía diabética en cualquiera de los ojos
    2. Antecedentes de vitrectomía, cirugía submacular o fotocoagulación macular en el ojo en estudio
    3. Presencia de cataratas de importancia clínica que puedan precisar cirugía durante el periodo del estudio en el ojo en estudio
    4. Cualquier otro trastorno médico ocular o no ocular o psiquiátrico importante que, en opinión del investigador, pueda suponer un riesgo para el sujeto o influir en los resultados del estudio
    5. Tener una contraindicación a recibir prednisolona/prednisona oral
    6. Haber participado en otro estudio de investigación en el que se utilice un producto en investigación en las 12 semanas previas o el equivalente a cinco semividas, lo que suponga más tiempo, o haber recibido una terapia génica o celular en algún momento
    7. No estar dispuesto a utilizar dos métodos anticonceptivos (uno de los cuales sea un método de barrera) durante 90 días después de la administración, si procede
    8. Tener antecedentes o presencia de carcinoma espinocelular cutáneo
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    - The change from baseline to Week 48 in GA area as measured by fundus autofluorescence (FAF)
    Principal:
    - Variación del área de AG a lo largo del tiempo, determinada mediante autofluorescencia del fondo de ojo (AFF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Weeks 12, 24, 36, 48 (EoS), Early termination visit (ETV)
    Selección, Semana 12, 24, 36, 48 final del estudio (FDE), Visita de retirada premature (VRP)
    E.5.2Secondary end point(s)
    Secondary:
    • Frequency of Treatment Emergent Adverse Events
    • Change on ophthalmic examination
    • Change in other parameters of safety, including imaging modalities, Best Corrected Visual Acuity (BCVA), vital signs, and laboratory assessments
    • Change in retinal microstructures on spectral domain optical coherence tomography (SD-OCT)
    • Change in area of nascent GA on SD-OCT
    • Change in GA morphology on colour fundus photography
    • Macular Sensitivity as assessed by Mesopic Microperimetry
    • Change in BCVA Score via the early treatment for diabetic retinopathy (ETDRS) chart
    • Change in Low Luminance Difference (LLD) via the ETDRS chart
    • Change in reading performance as assessed by Minnesota Low-Vision Reading Test (MNRead) Chart
    • Change in Functional Reading Independence Index
    • Change in quality of life measured on the Visual Functioning Questionnaire-25 (VFQ-25)
    • Frecuencia de acontecimientos adversos surgidos durante el tratamiento
    • Cambios en la exploración oftalmológica
    • Cambios en otros parámetros de seguridad, incluidas las modalidades de imagen, mejor agudeza visual corregida (MAVC), constantes vitales y evaluaciones analíticas
    • Variación de las microestructuras retinianas en la tomografía de coherencia óptica de dominio espectral (TCO-DE)
    • Variación de la superficie de AG incipiente en la TCO-DE
    • Variación de la morfología de la AG en la fotografía en color del fondo de ojo
    • Sensibilidad macular evaluada mediante microperimetría en condiciones mesópicas
    • Variación de la puntuación de la MAVC mediante el optotipo del estudio Tratamiento precoz de la retinopatía diabética (ETDRS)
    • Variación de la diferencia de luminancia baja (DLB) mediante el optotipo del ETDRS
    • Variación del rendimiento en lectura evaluado mediante la prueba de lectura de Minnesota para pacientes con poca visión (MNRead)
    • Cambio en el índice de independencia lectora funcional
    • Variación de la calidad de vida medida con el Cuestionario de función visual-25 (VFQ-25)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • AEs-Randomisation, pre and post surgery/surgery, Day3, Weeks 1, 2, 5, 12, 24, 36, 48 (EoS), Early termination visit (ETV)
    • Ophthalmic exam-Screening, pre and post surgery, Wks 5, 12, 24, 36, 48, ETV
    • Other parameters of safety-Screening, pre and post surgery, Wks 1, 5, 12, 24, 36, 48, ETV
    • SD-OCT-Screening, post surgery, Wks 5, 12, 24, 36, 48, ETV
    • Colour fundus photog-Screening, Wk 48, ETV
    • Microperimetry-Screening, pre surgery, Wks 12, 24, 36, 48, ETV
    • BCVA with ETDRS-Screening, pre surgery, Wks 1, 5, 12, 24, 36, 48, ETV
    • LLD with ETDRS-Screening, pre surgery, Wks 12, 24, 36, 48, ETV
    • MNRead-Screening, Wks 24, 36, 48, ETV
    • Functional Reading Independence Index-Screening, Wks 24, 36, 48, ETV
    • VFQ-25-Screening, Wks 24, 36, 48, ETV
    • Acontecimientos adversos-Aleatorización,pre y posquirúrgica/intervención quirúrgica,Día 3,Semana 1,2,5,12,24,36,48,EoS,VRP
    • Exploración oftalmológica-Selección,pre y posquirúrgica,Semana 5,12,24,36,48,VRP
    • Cambios en otros parámetros de seguridad-Selección,pre y posquirúrgica,Semana 1,5,12,24,36,48,VRP
    • SD-OCT-Selección, posquirúrgica, Semana 5,12,24,36,48,VRP
    • Fotografía del fondo de ojo en color-Selección,Semana 48,VRP
    • Microperimetry-Selección, Prequirúrgica,Semana 12,24,36,48,VRP
    • MAVC con ETDRS-Selección, Prequirúrgica,Semana 1,5,12,24,36,48,VRP
    • DLB con ETDRS-Selección, Prequirúrgica,Semana 12,24,36,48,VRP
    • MNRead-Selección,Semana 24,36,48,VRP
    • Índice de independencia lectora funcional-Selección,Semana 24,36,48,VRP
    • VFQ-25-Selección,Semana 24, 36, 48, VRP
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.1Randomised Yes
    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
    Todos los involucrados en el estudio desconocerán la dosis recibida por los sujetos asignados aGT005
    All involved with the study will be masked to the dose received for subjects allocated to GT005
    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
    Grupo de control sin tratamiento
    Untreated control group
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    France
    Germany
    Netherlands
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days2
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 54
    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)
    All subjects who receive treatment with GT005, including those that have withdrawn from the study for any reason, will, subject to consent, be enrolled in a separate long-term follow-up study (ORACLE). The long-term follow-up study will evaluate the long-term safety and durability of GT005 after the final follow-up visit at Week 48.
    Todos los sujetos que reciban tratamiento con GT005, incluidos los que se hayan retirado del estudio por cualquier motivo, serán invitados a participar en un estudio de seguimiento a largo plazo (ORACLE) después de la visita de seguimiento final en la semana 48.
    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 Decision2020-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-08-24
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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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