Status:
RECRUITING
A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Lead Sponsor:
Regenerative Patch Technologies, LLC
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Dry Age-related Macular Degeneration
Geographic Atrophy
Eligibility:
All Genders
55-90 years
Phase:
PHASE2
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. ...
Eligibility Criteria
Inclusion
- Eligible participants include:
- Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
- 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.
- Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
- 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.
- 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.
- Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
- Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
- Participants also must be willing and able to provide written, signed informed consent for this study.
- Participants able to complete the baseline microperimetry retinal sensitivity testing.
- On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2040
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06557460
Start Date
August 1 2025
End Date
December 1 2040
Last Update
August 15 2025
Active Locations (5)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
3
USC - Keck
Los Angeles, California, United States, 90033
4
University Retina
Lemont, Illinois, United States, 60439