A Phase 12a Study of Eyecyte-RPE12 Stem Cell Injection for Safety and Effectiveness in Treating Geographic Atrophy from Dry Age-Related Macular Degeneration in Adults Aged 50 to 100

What this Trial Is About

Researchers are evaluating the safety and potential effectiveness of a new stem cell treatment called Eyecyte-RPE for people aged 50 and older with Geographic Atrophy GA caused by dry Age-related Macular Degeneration d-AMD. GA is a late stage of dry AMD that leads to progressive and irreversible vision loss. This trial is a Phase 12a study conducted in India, aiming to address the unmet need for treatments that can restore damaged retinal cells and improve vision quality. Participants will receive a single subretinal injection of Eyecyte-RPE, which contains retinal pigment epithelial cells derived from stem cells. There are three dose levels 100,000 cells, 200,000 cells, or 300,000 cells, depending on group assignment. After the injection, participants will be closely monitored for safety and potential benefits. The study uses advanced imaging tools like Fundus Autofluorescence, Optical Coherence Tomography, and other vision assessments to track changes. During the study, participants will attend scheduled visits for eye exams, imaging tests, vision tests, and quality of life questionnaires up to 12 months after treatment. Researchers will focus on measuring changes in the GA area, visual acuity, retinal sensitivity, and overall visual function. Safety monitoring includes checks for any adverse effects or complications related to the injection or immunosuppression therapy. The total participation duration is about one year, ensuring thorough follow-up.

Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.