A First in Human Phase 1 / 2 Multi-center Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CTx001 Administered Via a Single Subretinal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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.
• 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