Regenerative Patch Technologies announced that the first 2 patients have been treated in a phase 2b clinical trial evaluating its allogeneic bioengineered retinal pigment epithelium (RPE) cell implant for advanced dry age-related macular degeneration with geographic atrophy. The study, known as PATCH AMD, is a randomized, assessor-masked, multicenter trial designed to further assess safety and efficacy while expanding on findings from the company’s completed phase 1/2a program.
In the earlier trial, patients were followed for a mean of nearly 37 months. At final follow-up, 27% of treated eyes experienced gains of more than 5 letters in visual acuity, compared with 7% of untreated fellow eyes. Vision loss of more than 5 letters occurred more frequently in nonimplanted eyes than in treated eyes.
The PATCH AMD study will enroll patients with less advanced disease to better evaluate the implant’s potential effect on visual function, the company said in a press release. The trial will also assess a cryopreserved formulation of the implant, which allows for long-term storage and shipment to clinical sites before thawing and implantation. The study is being conducted at multiple centers in California, Illinois, and Texas. RP







