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

• Conditions: Age Related Macular Degeneration (AMD)

• 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.

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2028-06-02
• Study Completion: 2028-06-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 225

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (31)

Retina Consultants San Diego - Poway; 🇺🇸 Poway, California, United States

Southwest Retina Research Center; 🇺🇸 Durango, Colorado, United States

Vitreo Retinal Associates Pa - the Millennium Center Location; 🇺🇸 Gainesville, Florida, United States

Rand Eye Institute, Inc. (Rei); 🇺🇸 Pompano Beach, Florida, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

University Retina and Macula Associates, P.C. - Lemont Office; 🇺🇸 Lemont, Illinois, United States

Midwest Eye Institute Northside; 🇺🇸 Indianapolis, Indiana, 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

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