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  

Age Related Macular Degeneration (AMD) Clinical Trial

Official 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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Age Related Macular Degeneration (AMD)
• Atrophy
• Geographic Atrophy
• Macular Degeneration

• NCT number: NCT05481827
• Study type: Interventional
• Source: Gyroscope Therapeutics Limited
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: July 12, 2022
• Completion date: June 2, 2028