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RECRUITING
NCT06557460
PHASE2

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

Sponsor: Regenerative Patch Technologies, LLC

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-01

Completion Date

2040-12

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DEVICE

Surgical implantation of the CPCB-RPE1 implant

Surgical implantation of the CPCB-RPE1 implant

Locations (5)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Retina Associates of Southern California

Huntington Beach, California, United States

USC - Keck

Los Angeles, California, United States

University Retina

Lemont, Illinois, United States

Retina Consultants of Texas

The Woodlands, Texas, United States