Recruiting
Phase 2

CPCB-RPE1

Sponsor:

Regenerative Patch Technologies, LLC

Code:

NCT06557460

Conditions

Dry Age-related Macular Degeneration

Geographic Atrophy

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Surgical implantation of the CPCB-RPE1 implant

Study Details

Brief 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

Study ID

NCT06557460

Start date

Aug 1, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).

Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).

sham comparator: Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Interventions

Surgical implantation of the CPCB-RPE1 implant

Surgical implantation of the CPCB-RPE1 implant

Primary outcome measure

  • Change in retinal sensitivity [ Time Frame: 1 year post implantation ]

Central Contacts and Locations

Central contacts

Locations

Retina-Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Retina Associates of Southern California

Recruiting

Huntington Beach, California, United States, 92647

Contacts

USC - Keck

Recruiting

Los Angeles, California, United States, 90033

Contacts

University Retina

Recruiting

Lemont, Illinois, United States, 60439

Contacts

Retina Consultants of Texas

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

More Information

Sponsor

Regenerative Patch Technologies, LLC

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regenerative Patch Technologies, LLC on 2026-03-25.