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

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Complement Therapeutics
Study ID
NCT07392255
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CTx001 — GENETIC
    Subretinal administration of CTx001

Study Details

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.

Key Dates

Start date
Dec 30, 2025
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2032

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Low Dose
  • Experimental: Cohort 2
    Medium Dose
  • Experimental: Cohort 3
    High Dose
  • Experimental: Cohort 4
    Expansion of a dose selected from Cohort 1-3
  • Experimental: Cohort 5
    Expansion of a second dose selected from Cohort 1-3

Primary Outcome Measure

To monitor the safety and tolerability of a single administration of CTx001 at 3 dose levels [ Time Frame: From dosage to Week 52 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Midwest Eye InstituteCarmelIndiana46290-
Sierra Eye AssociatesRenoNevada89502-
Retina Foundation of the SouthwestDallasTexas75231-
Gundersen Health SystemLa CrosseWisconsin54601-

Find similar trials in Carmel, IN

By research site
Midwest Eye Institute· Carmel, INSierra Eye Associates· Reno, NVRetina Foundation of the Southwest· Dallas, TXGundersen Health System· La Crosse, WI

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