NCT07392255PHASE1, PHASE2Recruiting
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
Complement Therapeutics
Start Date
12/30/2025
Completion Date
6/30/2032
Summary
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.
Eligibility Criteria
Age Range: 55 years to No maximum
Inclusion Criteria:
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
Exclusion Criteria:
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
Interventions
GENETIC
CTx001
Conditions
Geographic Atrophy Secondary to Age-related Macular Degeneration
Locations
Midwest Eye Institute
Carmel, Indiana 46290
United States
Sierra Eye Associates
Reno, Nevada 89502
United States
Retina Foundation of the Southwest
Dallas, Texas 75231
United States
Gundersen Health System
La Crosse, Wisconsin 54601
United States
The Retina Clinic London
London, London W1G 7LB
United Kingdom