NCT06557460

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Subjects With Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) - PATCH AMD

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Regenerative Patch Technologies, LLC · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea. Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups: * The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). * The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Conditions

• Dry Age-related Macular Degeneration
• Geographic Atrophy

Interventions

Type	Name	Description
DEVICE	Surgical implantation of the CPCB-RPE1 implant	Surgical implantation of the CPCB-RPE1 implant

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-12-01
• Completion: 2040-12-01
• First posted: 2024-08-16
• Last updated: 2026-03-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study