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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

Study acronym: ORACLE
StatusEnrolling by Invitation
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 3 words
  2. Study sites: 25 to 32v9
  3. Study sites: 18 to 25
    • Study arms: 0 to 1
    v8
  4. Phase: Not specified to Phase 2v7 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 200 to 225
    • Primary completion date: Mar 16, 2028 to Jun 2, 2028
    • Study completion date: Sep 16, 2028 to Jun 2, 2028
    • Eligibility criteria shortened, about 49 words
    • Secondary endpoints shortened, about 20 words
    • Study description expanded, about 48 words
    • Study title expanded, about 9 words
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 14 to 18v5
  2. Study sites: 5 to 14v4
  3. Study sites: 1 to 5v3
  4. Secondary endpoints: 7 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05481827
Lead Sponsor Gyroscope Therapeutics Limited
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 Age Related Macular Degeneration (AMD)
Related terms Anetoderma, Geographic Atrophy, Macular Degeneration, Retinal Degeneration, Retinal Diseases
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov