An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Wor… (NCT07392255) | Clinical Trial Compass
RecruitingPhase 1/2
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
United States75 participantsStarted 2025-12-30
Plain-language 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.
Who can participate
Age range55 Years
SexALL
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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 inte…
What they're measuring
1
To monitor the safety and tolerability of a single administration of CTx001 at 3 dose levels