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
ORACLE
3 other identifiers
interventional
225
6 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Longer than P75 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2022
CompletedFirst Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 2, 2028
March 22, 2024
March 1, 2024
5.9 years
July 28, 2022
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of ocular and systemic adverse events (AEs)
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.
up to Week 260
Study Arms (1)
GT005
EXPERIMENTALGT005 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Able and willing to give written informed consent
- Received GT005 in an antecedent study, GT005-01 (FOCUS, NCT03846193), GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445)
- Willing to attend study visits and complete the study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gyroscope Therapeutics Limitedlead
- Novartis Pharmaceuticalscollaborator
Study Sites (32)
Retina Consultants San Diego - Poway
Poway, California, 92064, United States
Southwest Retina Research Center
Durango, Colorado, 81303, United States
Vitreo Retinal Associates Pa - the Millennium Center Location
Gainesville, Florida, 32607-2557, United States
Rand Eye Institute, Inc. (Rei)
Pompano Beach, Florida, 33064, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
University Retina and Macula Associates, P.C. - Lemont Office
Lemont, Illinois, 60439-7421, United States
Midwest Eye Institute Northside
Indianapolis, Indiana, 46290, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
The Retina Care Center, Llc - Baltimore Location
Baltimore, Maryland, 21209, United States
Ophthalmic Consultants of Boston (OCB)
Boston, Massachusetts, 02114, United States
Pepose Vision Institute, P.C - Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Columbia University Medical Center
New York, New York, 10032, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Sterling Vision - Oregon Retina, Llp
Eugene, Oregon, 97401-2127, United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants of Austin
Austin, Texas, 78705, United States
Texas Retina Associates (Tra) - Dallas Main
Dallas, Texas, 75231, United States
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
Houston, Texas, 77030-2727, United States
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
Houston, Texas, 77030, United States
Retinal Consultants of San Antonio (Rcsa) - Medical Center
San Antonio, Texas, 78240, United States
The University of Melbourne - The Centre for Eye Research Australia (CERA)
Melbourne E., Victoria, 3002, Australia
CHU Dijon - Hopital Mitterrand
Dijon, 21000, France
CHU de Nantes - Hôtel-Dieu
Nantes, 44093, France
Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Instituto de microcirugía ocular
Barcelona, 08035, Spain
Clinica Baviera
Madrid, 28046, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008, Spain
The Retina Clinic London
London, W1G 7LB, United Kingdom
South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
August 1, 2022
Study Start
July 12, 2022
Primary Completion (Estimated)
June 2, 2028
Study Completion (Estimated)
June 2, 2028
Last Updated
March 22, 2024
Record last verified: 2024-03