Phase 12a Study to Assess Safety and Tolerability of RPE Stem Cell Transplantation for Dry Age-related Macular Degeneration in Adults Over 55

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new therapy called RPESC-RPE-4W, which involves transplanting stem cell-derived retinal pigment epithelial RPE cells to treat dry age-related macular degeneration AMD. This first-in-human Phase 12a open-label study aims to enroll 18 adults with dry AMD to assess this treatment. The study is sponsored by Luxa Biotechnology, LLC and focuses on monitoring safety and visual function over time. Participants will receive a single dose of RPESC-RPE-4W cells transplanted under the macular area of the eye. There are three groups in this study, each receiving a different dose 50,000 cells, 150,000 cells, or 250,000 cells. The study is non-randomized and open-label, meaning both researchers and participants know which dose is administered. During the 24-month study period, participants will undergo regular assessments including measurements of best corrected visual acuity, visual sensitivity using microperimetry, and changes in geographic atrophy lesion area. Researchers will also look for structural changes in the retina. Safety monitoring will be ongoing to evaluate the tolerability of the transplanted cells. Participants will be followed for two years to assess both safety and potential changes in vision.

Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)