Comparing 4 approaches for geographic atrophy secondary to age-related macular

Exclusion

• −Any ocular disease or condition that is not GA secondary to AMD: Macular atrophy secondary to a condition other than AMD; Exudative AMD diagnosis or any history of or active macular neovascularization (in study eye or fellow eye) and/or retinal angiomatous proliferation associated with AMD or any other cause; Presence of an active ocular disease that in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → compromises or confounds visual function; Active ocular or periocular infection or active uncontrolled intraocular inflammation within 3 months of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →; History of vitrectomy, retinal detachment, or corneal transplant in the study eye; Active/history of uveitis.
• −Any ocular condition that prevents adequate imaging.
• −Medical, cognitive or psychiatric conditions that, in the opinion of the Investigator, make consistent study assessment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study.
• −Hospitalization within 1 year prior to Screening that, in the opinion of the Investigator, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or could increase the risk to the participant by participating in the study or confound the outcome of the study.
• −Any Screening test (e.g., ECG) or laboratory value (e.g., hematology) that in the opinion of the Investigator and/or Medical Monitor is clinically significant and renders the participant not suitable for study participation.
• −Participant has a direct contraindication to the steroid regimen (both oral and topical) or has a condition that significantly increases the risk of complication.
• −History of laser therapy in the macular region.
• −History of intravitreal (IVT) therapy, such as IVT steroid injections, within 6 months prior to Screening.
• −COVID-19 vaccine within 90 days of Screening or plan to receive COVID-19 vaccine within 6 months of treatment.
• −Active use of systemic immunomodulatory drugs or systemic corticosteroids in the last 60 days. Topical steroids are not exclusionary.
• −Prior participation in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study for GA within the past 12 months from the last dosing at Screening.
• −Active/history of malignancy within the past 5 years from Screening or any previous therapeutic radiation in the region of the study eye(s) at Screening. History of non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia (CIN), and localized prostate cancer after treatment are not exclusionary.
• −Intraocular surgery (including lens replacement surgery) within 3 months prior to Screening.