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NCT06557460From ClinicalTrials.govRecruiting

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

  • Dry Age-related Macular Degeneration
  • Geographic Atrophy

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Regenerative Patch Technologies, LLC
Enrolment target
24
Started
1 August 2025
Main results due
December 2027
Study sites
5
Registry updated
23 September 2026

Can you take part?

  • Ages 55 years to 90 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Eligible participants include:

1. Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
2. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 15.0 mm2 of geographic atrophy involving the fovea.
3. Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
4. The best-corrected visual acuity (BCVA) of the eye to receive the implant will be ≥20/200 (35 EDTRS letters) to 20/63 (60 EDTRS letters) inclusive. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant.
5. Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required.
6. Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
7. Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
8. Participants also must be willing and able to provide written, signed informed consent for this study.
9. Participants able to complete the baseline microperimetry retinal sensitivity testing.
10. On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.

What this study is about

In the sponsor’s own words, from the registry.

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)

Study sites(5)

  • Retina Associates of Southern California

    Huntington Beach, California, United States

    Recruiting

  • USC - Keck

    Los Angeles, California, United States

    Recruiting

  • University Retina

    Lemont, Illinois, United States

    Recruiting

  • Austin Retina Associates

    Austin, Texas, United States

    Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas, United States

    Recruiting

Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06557460. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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