Clinical Advances in Retinal Implants: Phase IIb Trial of CPCB-RPE1 for Advanced AMD

Regenerative Patch Technologies has launched a Phase IIb trial of the CPCB-RPE1 implant for advanced dry age-related macular degeneration.

Earlier Phase I/IIa data suggested vision improvement or stabilization in a subset of treated eyes, and the Phase IIb is designed to confirm those signals in a larger, controlled cohort while refining the safety profile.

The trial has treated the first two patients to date. Early observations include improvement or stabilization in a subset of implanted eyes, and importantly, no new safety signals have been reported so far. Monitoring has emphasized visual acuity and lesion progression; initial follow-up is consistent with the previously observed safety profile.

CPCB-RPE1 is a bioengineered retinal pigment epithelium (RPE) cell patch intended to replace damaged RPE and underlying Bruch's membrane in geographic atrophy. The implant is designed to support photoreceptor survival and thereby stabilize or improve vision through restoration of metabolic and structural support. Delivery is by surgical subretinal implantation of an allogeneic RPE construct that is cryopreserved for site-level thawing prior to use. Replacing the RPE and Bruch's membrane aims to interrupt the degenerative cascade in advanced dry AMD and provides the clinical rationale for the approach.