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
- Conditions
- Age Related Macular Degeneration (AMD)
- Interventions
- Genetic: GT005
- Registration Number
- NCT05481827
- Lead Sponsor
- Gyroscope Therapeutics Limited
- 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.
- Detailed Description
This is a prospective, multi-centre, long-term, follow-up study for participants who have previously received GT005 in one of the antecedent clinical studies which were prematurely terminated GT005-01 (FOCUS), GT005-02 (EXPLORE) or GT005-03 (HORIZON). Participants from GT005-01 (FOCUS) study with only 1 last study visit to be conducted (Week 240) will remain in the study to complete their last visit. No investigational product will be administered within this study, and participants will be invited to enter ORACLE upon their completion or termination of the antecedent interventional study (whichever is soonest). This study will consist of up to three study visits prior to Week 96, and up to five study visits thereafter, for an overall period of 5-years post-GT005 administration.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 225
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GT005 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
- Primary Outcome Measures
Name Time Method Incidence and severity of ocular and systemic adverse events (AEs) up to Week 260 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Retina Consultants San Diego - Poway
🇺🇸Poway, California, United States
Vitreo Retinal Associates Pa - the Millennium Center Location
🇺🇸Gainesville, Florida, United States
Southwest Retina Research Center
🇺🇸Durango, Colorado, United States
Midwest Eye Institute Northside
🇺🇸Indianapolis, Indiana, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Rand Eye Institute, Inc. (Rei)
🇺🇸Pompano Beach, Florida, United States
University Retina and Macula Associates, P.C. - Lemont Office
🇺🇸Lemont, Illinois, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
The Retina Care Center, Llc - Baltimore Location
🇺🇸Baltimore, Maryland, United States
Ophthalmic Consultants of Boston (OCB)
🇺🇸Boston, Massachusetts, United States
Pepose Vision Institute, P.C - Midwest Vision Research Foundation
🇺🇸Chesterfield, Missouri, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Sterling Vision - Oregon Retina, Llp
🇺🇸Eugene, Oregon, United States
Mid Atlantic Retina - Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Retina Consultants of Austin
🇺🇸Austin, Texas, United States
Texas Retina Associates (Tra) - Dallas Main
🇺🇸Dallas, Texas, United States
Retinal Consultants of San Antonio (Rcsa) - Medical Center
🇺🇸San Antonio, Texas, United States
CHU Dijon - Hopital Mitterrand
🇫🇷Dijon, France
The University of Melbourne - The Centre for Eye Research Australia (CERA)
🇦🇺Melbourne E., Victoria, Australia
Universitaetsklinikum Schleswig-Holstein
🇩🇪Luebeck, Germany
CHU de Nantes - Hôtel-Dieu
🇫🇷Nantes, France
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Instituto de microcirugía ocular
🇪🇸Barcelona, Spain
Clinica Baviera
🇪🇸Madrid, Spain
Clinica Universidad de Navarra - Pamplona
🇪🇸Pamplona, Spain
The Retina Clinic London
🇬🇧London, United Kingdom
South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary
🇬🇧Sunderland, United Kingdom
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
🇺🇸Houston, Texas, United States