FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD

Exclusion Criteria

• •1. Have evidence or history of Choroidal Neovascularisation (CNV) in the study eye. Subjects are permitted to have CNV in the fellow eye defined as either:
• •1. Non-exudative/sub-clinical fellow eye CNV identified at screening, or
• •2. Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to screening
• •2. Presence of moderate/severe non-proliferative diabetic retinopathy or worse in the study eye
• •3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
• •4. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminum garnet capsulotomy is permitted if performed \>10 weeks prior to Visit 1
• •5. Have clinically significant cataract that may require surgery during the study period in the study eye
• •6. Presence of moderate to severe glaucomatous optic neuropathy in the study eye; uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve surgery is also excluded
• •7. Axial myopia of greater than -8 diopters in the study eye
• •8. Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the Age-Related Eye Disease Study (AREDS) formula
• •9. Have received a gene or cell therapy at any time
• •10. Have a contraindication to the specified protocol corticosteroid regimen
• •11. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
• •12. Active malignancy within the past 12 months, except for: Appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥12 months
• •13. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
• •14. Cohorts 5 to 7 only: presence of metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, and other implanted electrodes or stimulators