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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05481827
Registration number
NCT05481827
Ethics application status
Date submitted
28/07/2022
Date registered
1/08/2022
Date last updated
22/03/2024
Titles & IDs
Public title
ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study
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Scientific title
ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study
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Secondary ID [1]
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2020-003987-22
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Secondary ID [2]
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GT-ORACLE
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Universal Trial Number (UTN)
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Trial acronym
ORACLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration (AMD)
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - GT005
Experimental: GT005 - GT005 is a gene therapy for GA and is a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I. GT005 was administered to all participants in an antecedent study prior to enrollment in ORACLE and GT005 is not administered in the ORACLE study
Other interventions: GT005
GT005 is a gene therapy for GA and is a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I. GT005 was administered to all participants in an antecedent study prior to enrollment in ORACLE and GT005 is not administered in the ORACLE study.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and severity of ocular and systemic adverse events (AEs)
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Assessment method [1]
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An AE is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the IMP.
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Timepoint [1]
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up to Week 260
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Eligibility
Key inclusion criteria
1. Able and willing to give written informed consent
2. Received GT005 in an antecedent study, GT005-01 (FOCUS, NCT03846193), GT005-02
(EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445)
3. Willing to attend study visits and complete the study procedures.
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/06/2028
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Actual
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Sample size
Target
225
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The University of Melbourne - The Centre for Eye Research Australia (CERA) - Melbourne E.
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Recruitment postcode(s) [1]
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3002 - Melbourne E.
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Illinois
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Ohio
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Oregon
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Pennsylvania
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Texas
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France
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Dijon
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France
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Nantes
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Germany
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Luebeck
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Germany
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Tuebingen
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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United Kingdom
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London
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United Kingdom
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Sunderland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gyroscope Therapeutics Limited
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novartis Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the long-term safety of GT005 in participants with
Geographic Atrophy (GA) secondary to AMD who have been treated in an antecedent study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05481827
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05481827
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