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An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)

Study acronym: Opti-GAIN
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 5 to 7
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Study sites: 4 to 5v6
  3. Study sites: 3 to 4v5
  4. Study sites: 1 to 3v4
  5. Re-verified, no change to tracked fieldsv3
  6. Secondary endpoints reorderedv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD). Safety and efficacy will be measured at regular intervals for 2 years after which long-term safety will be assessed annually for up to 5 years.
Trial Details
NCT Number NCT07392255
Lead Sponsor Complement Therapeutics
Conditions
(from sponsor)		 Geographic Atrophy Secondary to Age-related Macular Degeneration
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov