RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Complement Therapeutics • ClinicalTrials.gov ID: NCT07392255

Registry updated: 2026-10-16

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Description

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.

Interventions

CTx001 (Genetic)
Subretinal administration of CTx001

Eligibility criteria

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

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Locations

Midwest Eye Institute — Carmel, Indiana, United States
Sierra Eye Associates — Reno, Nevada, United States
Retina Foundation of the Southwest — Dallas, Texas, United States
Gundersen Health System — La Crosse, Wisconsin, United States
Gloucestershire Royal Hospital — Gloucester, Gloucestershire, United Kingdom
Moorfields Eye Hospital — London, London, United Kingdom
The Retina Clinic London — London, London, United Kingdom
Sunderland Specialist Eye Hospital — Sunderland, Tyne and Wear, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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