An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
Recruiting now · Phase 1/Phase 2
Conditions studied: Geographic Atrophy Secondary to Age-related Macular Degeneration
In brief
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 facts
- Study ID
- NCT07392255
- Run by
- Complement Therapeutics
- People needed
- 75
- Starts
- 2025-12-30
- Expected to finish
- 2032-06-30
- Last updated by the study team
- 2026-06-22
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meet protocol-defined age eligibility
- Have bilateral geographic atrophy secondary to AMD, confirmed by the Reading Center
- Meet baseline lesion size requirements, as assessed by fundus autofluorescence imaging
- Meet best-corrected visual acuity and low-luminance visual acuity criteria, as measured by ETDRS charts
- Meet retinal sensitivity criteria, as measured by microperimetry
- Have sufficient fellow-eye visual function to ensure navigational vision
- Have adequate historical SD-OCT imaging available for longitudinal assessment
- Meet reproductive status and contraception requirements, where applicable
- Be able and willing to provide informed consent and comply with study procedures
You may not qualify if…
- Macular atrophy or retinal disease not attributable to AMD
- Evidence of current or prior choroidal neovascularization (wet AMD)
- Prior intraocular, macular, or retinal surgery or laser treatment that may confound assessments
- Prior AMD-directed or intravitreal therapy in the study eye, except permitted supplements
- Prior exposure to complement inhibitor therapies
- Ocular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging
- Uncontrolled glaucoma, diabetic retinopathy, or clinically significant refractive error
- Aphakia or compromised posterior capsule, except as permitted by protocol
- Systemic medical or psychiatric conditions that may increase risk or limit compliance
- Recent participation in another interventional clinical study or exposure to investigational therapies
- Any condition that, in the investigator's judgment, poses unacceptable risk or precludes safe participation
Where it is running
- Midwest Eye Institute — Carmel, Indiana, United States (enrolling)
- Sierra Eye Associates — Reno, Nevada, United States (enrolling)
- Retina Foundation of the Southwest — Dallas, Texas, United States (enrolling)
- Gundersen Health System — La Crosse, Wisconsin, United States (enrolling)
- The Retina Clinic London — London, London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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