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)

March 21, 2024 updated by: Gyroscope Therapeutics Limited
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

225

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne E., Victoria, Australia, 3002
        • The University of Melbourne - The Centre for Eye Research Australia (CERA)
  • France
      • Dijon, France, 21000
        • CHU Dijon - Hopital Mitterrand
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel-Dieu
  • Germany
      • Luebeck, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Spain
      • Barcelona, Spain, 08035
        • Instituto de Microcirugia Ocular
      • Madrid, Spain, 28046
        • Clinica Baviera
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
  • United Kingdom
      • London, United Kingdom, W1G 7LB
        • The Retina Clinic London
      • Sunderland, United Kingdom, SR2 9HP
        • South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary
  • United States
    • California
      • Poway, California, United States, 92064
        • Retina Consultants San Diego - Poway
    • Colorado
      • Durango, Colorado, United States, 81303
        • Southwest Retina Research Center
    • Florida
      • Gainesville, Florida, United States, 32607-2557
        • Vitreo Retinal Associates Pa - the Millennium Center Location
      • Pompano Beach, Florida, United States, 33064
        • Rand Eye Institute, Inc. (Rei)
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
    • Illinois
      • Lemont, Illinois, United States, 60439-7421
        • University Retina and Macula Associates, P.C. - Lemont Office
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute Northside
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center, Llc - Baltimore Location
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston (OCB)
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pepose Vision Institute, P.C - Midwest Vision Research Foundation
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Oregon
      • Eugene, Oregon, United States, 97401-2127
        • Sterling Vision - Oregon Retina, Llp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina - Wills Eye Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Consultants of Austin
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates (Tra) - Dallas Main
      • Houston, Texas, United States, 77030-2727
        • Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
      • Houston, Texas, United States, 77030
        • Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of San Antonio (RCSA) - Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Approximately 200 participants are planned for this study.

All participants treated with GT005 in the GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445) study will be invited to enroll in this long-term, follow-up study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of ocular and systemic adverse events (AEs)
Time Frame: 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.
up to Week 260

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the long-term durability of GT005 on GA progression
Time Frame: 260 weeks
Change from baseline (pre-administration of GT005) in GA area as measured by fundus autofluorescence (FAF)
260 weeks
To evaluate the long-term durability of GT005 on functional measures
Time Frame: 260 weeks
Change from baseline (pre-administration of GT005) in best corrected visual acuity (BCVA) via early treatment diabetic retinopathy study (ETDRS) scale chart
260 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyroscope Therapeutics Limited

Collaborators

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Estimated)

June 2, 2028

Study Completion (Estimated)

June 2, 2028

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-ORACLE
  • 2020-003987-22 (EudraCT Number)
  • CPPY988A12203B (Other Identifier: Novartis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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