A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
NCT ID: NCT06557460
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2025-08-01
2040-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD
NCT02590692
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
NCT04339764
A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
NCT00447954
A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa
NCT00447980
A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa
NCT00447993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
Surgical implantation of the CPCB-RPE1 implant
Surgical implantation of the CPCB-RPE1 implant
Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
Surgical implantation of the CPCB-RPE1 implant
Surgical implantation of the CPCB-RPE1 implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgical implantation of the CPCB-RPE1 implant
Surgical implantation of the CPCB-RPE1 implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 10.0 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.
55 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California Institute for Regenerative Medicine (CIRM)
OTHER
Regenerative Patch Technologies, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RPT-14-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.