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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

NCT05481827 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2024-03-22

No results posted yet for this study

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.

Conditions

  • Age Related Macular Degeneration (AMD)

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2028-06-02
Completion
2028-06-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481827 on ClinicalTrials.gov