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By invitation only Phase 2 NCT05481827

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

Phase 2 – studying effectiveness and dosage
Conditions: Age Related Macular Degeneration (AMD)

Sponsor: Gyroscope Therapeutics Limited

trial.available_in: БГ
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.
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.
Who can participate
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.
Locations 6
Australia (1)
The University of Melbourne - The Centre for Eye Research Australia (CERA)
Melbourne E. , Victoria
France (1)
CHU Dijon - Hopital Mitterrand
Dijon
Germany (1)
Universitaetsklinikum Schleswig-Holstein
Lübeck
Spain (1)
Instituto de microcirugía ocular
Barcelona
United Kingdom (1)
The Retina Clinic London
London
United States (1)
Retina Consultants San Diego - Poway
Poway , California
Technical details
Status
By invitation only
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
55 Years
Healthy volunteers
No
Start date
12.07.2022
Completion date
02.06.2028
Registry ID
NCT05481827
Source
anzctr
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