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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GT005.
- Who it may be relevant to
- Registry conditions: Age Related Macular Degeneration (AMD). Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, France, Germany, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Genetic 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
- Incidence and severity of ocular and systemic adverse events (AEs) [Time frame: up to Week 260]
Eligibility criteria
Inclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 22 centers
- Retina Consultants San Diego - Poway — Poway
- Southwest Retina Research Center — Durango
- Vitreo Retinal Associates Pa - the Millennium Center Location — Gainesville
- Rand Eye Institute, Inc. (Rei) — Pompano Beach
- Retina Vitreous Associates of Florida — St. Petersburg
- University Retina and Macula Associates, P.C. - Lemont Office — Lemont
- Midwest Eye Institute Northside — Indianapolis
- Wolfe Eye Clinic — West Des Moines
- … and 14 more centers
Spain · 3 centers
- Instituto de microcirugía ocular — Barcelona
- Clinica Baviera — Madrid
- Clinica Universidad de Navarra - Pamplona — Pamplona
France · 2 centers
- CHU Dijon - Hopital Mitterrand — Dijon
- CHU de Nantes - Hôtel-Dieu — Nantes
Germany · 2 centers
- Universitaetsklinikum Schleswig-Holstein — Lübeck
- Universitaetsklinikum Tuebingen — Tübingen
United Kingdom · 2 centers
- The Retina Clinic London — London
- South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary — Sunderland
Australia · 1 center
- The University of Melbourne - The Centre for Eye Research Australia (CERA) — Melbourne E.
Identifiers
NCT: NCT05481827 · GT-ORACLE · 2020-003987-22 · CPPY988A12203B