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

NCT06557460 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: RPT-14-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

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

Geographic Atrophy; Dry Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change in retinal sensitivity

  Change in retinal sensitivity by microperimetry

  1 year post implantation

Secondary Outcomes (1)

• Change in best corrected visual acuity

  1 year post implantation

Study Arms (2)

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

EXPERIMENTAL

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

Device: Surgical implantation of the CPCB-RPE1 implant

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

SHAM COMPARATOR

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

Device: Surgical implantation of the CPCB-RPE1 implant

Interventions

Surgical implantation of the CPCB-RPE1 implant DEVICE

Surgical implantation of the CPCB-RPE1 implant

Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).; Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Regenerative Patch Technologies, LLC: lead
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (5)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Retina Associates of Southern California

Huntington Beach, California, 92647, United States

RECRUITING

USC - Keck

Los Angeles, California, 90033, United States

RECRUITING

University Retina

Lemont, Illinois, 60439, United States

RECRUITING

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

RECRUITING

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Clinical Research

CONTACT

833-734-3678; clinicaltrials@regenerativepatch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2040
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)