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

Age Related Macular Degeneration (AMD) Clinical Trial

— ORACLE  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05481827
• Other study ID #: GT-ORACLE
• Secondary ID: 2020-003987-22CP
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: July 12, 2022
• Est. completion date: June 2, 2028

Study information

• Verified date: March 2024
• Source: Gyroscope Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 225
• Est. completion date: June 2, 2028
• Est. primary completion date: June 2, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Australia	The University of Melbourne - The Centre for Eye Research Australia (CERA)	Melbourne E.	Victoria
France	CHU Dijon - Hopital Mitterrand	Dijon
France	CHU de Nantes - Hôtel-Dieu	Nantes
Germany	Universitaetsklinikum Schleswig-Holstein	Luebeck
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Spain	Instituto de microcirugía ocular	Barcelona
Spain	Clinica Baviera	Madrid
Spain	Clinica Universidad de Navarra - Pamplona	Pamplona
United Kingdom	The Retina Clinic London	London
United Kingdom	South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary	Sunderland
United States	Retina Consultants of Austin	Austin	Texas
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	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Texas Retina Associates (Tra) - Dallas Main	Dallas	Texas
United States	Southwest Retina Research Center	Durango	Colorado
United States	Sterling Vision - Oregon Retina, Llp	Eugene	Oregon
United States	Vitreo Retinal Associates Pa - the Millennium Center Location	Gainesville	Florida
United States	Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center	Houston	Texas
United States	Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center	Houston	Texas
United States	Midwest Eye Institute Northside	Indianapolis	Indiana
United States	University Retina and Macula Associates, P.C. - Lemont Office	Lemont	Illinois
United States	Columbia University Medical Center	New York	New York
United States	Mid Atlantic Retina - Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Rand Eye Institute, Inc. (Rei)	Pompano Beach	Florida
United States	Retina Consultants San Diego - Poway	Poway	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Associates of Western New York	Rochester	New York
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Retinal Consultants of San Antonio (Rcsa) - Medical Center	San Antonio	Texas
United States	Wolfe Eye Clinic	West Des Moines	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Gyroscope Therapeutics Limited	Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of ocular and systemic adverse events (AEs)	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.	up to Week 260