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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

NCT ID: NCT05481827

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2028-06-02

Brief Summary

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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.

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EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

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HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

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Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

NCT05893537

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GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)

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Detailed Description

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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.

Conditions

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Age Related Macular Degeneration (AMD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

GT005

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Gyroscope Therapeutics Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retina Consultants San Diego - Poway

Poway, California, United States

Site Status

Southwest Retina Research Center

Durango, Colorado, United States

Site Status

Vitreo Retinal Associates Pa - the Millennium Center Location

Gainesville, Florida, United States

Site Status

Rand Eye Institute, Inc. (Rei)

Pompano Beach, Florida, United States

Site Status

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Site Status

University Retina and Macula Associates, P.C. - Lemont Office

Lemont, Illinois, United States

Site Status

Midwest Eye Institute Northside

Indianapolis, Indiana, United States

Site Status

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

The Retina Care Center, Llc - Baltimore Location

Baltimore, Maryland, United States

Site Status

Ophthalmic Consultants of Boston (OCB)

Boston, Massachusetts, United States

Site Status

Pepose Vision Institute, P.C - Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Retina Associates of Western New York

Rochester, New York, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Sterling Vision - Oregon Retina, Llp

Eugene, Oregon, United States

Site Status

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Retina Consultants of Austin

Austin, Texas, United States

Site Status

Texas Retina Associates (Tra) - Dallas Main

Dallas, Texas, United States

Site Status

Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center

Houston, Texas, United States

Site Status

Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center

Houston, Texas, United States

Site Status

Retinal Consultants of San Antonio (Rcsa) - Medical Center

San Antonio, Texas, United States

Site Status

The University of Melbourne - The Centre for Eye Research Australia (CERA)

Melbourne E., Victoria, Australia

Site Status

CHU Dijon - Hopital Mitterrand

Dijon, , France

Site Status

CHU de Nantes - Hôtel-Dieu

Nantes, , France

Site Status

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status

Instituto de microcirugía ocular

Barcelona, , Spain

Site Status

Clinica Baviera

Madrid, , Spain

Site Status

Clinica Universidad de Navarra - Pamplona

Pamplona, , Spain

Site Status

The Retina Clinic London

London, , United Kingdom

Site Status

South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status

Countries

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United States Australia France Germany Spain United Kingdom

Other Identifiers

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2020-003987-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CPPY988A12203B

Identifier Type: OTHER

Identifier Source: secondary_id

GT-ORACLE

Identifier Type: -

Identifier Source: org_study_id

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