Phase IIa Study to Improve Subretinal Surgery and Test Safety and Effectiveness of OpRegen in People with Geographic Atrophy from Age-Related Macular Degeneration

What this Trial Is About

Researchers are studying the safety and success of delivering OpRegen cells through subretinal surgery in people with geographic atrophy caused by age-related macular degeneration AMD. This Phase IIa study focuses on how well the cells reach target areas in the eye and evaluates procedure-related side effects. There is also an optional substudy assessing a new retinal imaging device called EarlySight Cellularis Discovery to explore its usefulness for eye assessment, but this device does not affect clinical care or outcomes. Participants will receive a dose of up to approximately 200,000 OpRegen cells delivered into the subretinal space via surgery. The study is open-label and involves a single treatment group. The optional imaging substudy is available to those who meet additional criteria and can comply with extra assessments using the EarlySight Cellularis Discovery device. During the study, participants will undergo detailed eye exams including optical coherence tomography OCT imaging to observe retinal structure changes. Researchers will monitor the participants for adverse events and evaluate treatment delivery success at 3 months after surgery. The study is expected to continue until March 2031, with regular visits to assess safety and retinal improvements. Participation involves surgical procedures and follow-up assessments focused on the study eyes condition.

A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251