Phase 1b Study of ASP7317 Stem Cell Treatment for Geographic Atrophy in Dry Age-related Macular Degeneration in Adults 50 and Older

What this Trial Is About

Age-related macular degeneration AMD is an eye condition that causes gradual loss of sharp central vision, making activities like reading or driving difficult. This study focuses on people with geographic atrophy, the advanced stage of dry AMD, where damaged cells in the eye lead to vision loss. Researchers are evaluating ASP7317, a treatment made from human stem cells designed to replace damaged retinal cells and potentially improve vision. This Phase 1b study aims to assess the safety and tolerability of ASP7317 in senior adults with this condition. Participants receive ASP7317 through an injection under the macula after anesthesia, with three different dosage levels low, medium, and high. To reduce the risk of rejection, participants take tacrolimus and other medications before and after the injection to prevent infection. The study has two groups based on vision severitysevere and moderate vision losswith small subgroups receiving escalating doses. A medical panel reviews safety data after each dose before continuing or increasing the dose. Treatment and follow-up visits occur over 52 weeks. During the study, participants attend multiple clinic visits for eye exams, imaging, scans, and blood tests to monitor safety, vision changes, and any side effects. Vital signs such as blood pressure, pulse, and temperature are checked before and after treatment. Researchers track adverse events, graft rejection, and changes in vision and retinal health at set intervals up to one year. Participants may also have additional visits if needed for extra monitoring or care.

A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration