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

Korábbi kezelés

• 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
• Recent participation in another interventional clinical study or exposure to investigational therapies

Más betegség

• Macular atrophy or retinal disease not attributable to AMD
• Ocular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging
• Systemic medical or psychiatric conditions that may increase risk or limit compliance
• Any condition that, in the investigator's judgment, poses unacceptable risk or precludes safe participation

Egyéb

• Uncontrolled glaucoma, diabetic retinopathy, or clinically significant refractive error
• Aphakia or compromised posterior capsule, except as permitted by protocol

• 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