RecruitingPhase 2NCT06557460

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


Sponsor

Regenerative Patch Technologies, LLC

Enrollment

24 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Surgical implantation of the CPCB-RPE1 implant for people with dry age-related macular degeneration and geographic atrophy. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESurgical 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

View Full Details on ClinicalTrials.gov

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NCT06557460


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