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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Regenerative Patch Technologies, LLC
Study ID
NCT06557460
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgical implantation of the CPCB-RPE1 implant — DEVICE
    Surgical implantation of the CPCB-RPE1 implant

Study Details

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)

Key Dates

Start date
Aug 1, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2040

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211
[email protected]
833-734-3678
Retina Associates of Southern CaliforniaHuntington BeachCalifornia92647
[email protected]
833-734-3678
USC - KeckLos AngelesCalifornia90033
[email protected]
833-734-3678
University RetinaLemontIllinois60439
[email protected]
833-734-3678
Retina Consultants of TexasThe WoodlandsTexas77384
[email protected]
833-734-3678

Find similar trials in Beverly Hills, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CARetina Associates of Southern California· Huntington Beach, CAUSC - Keck· Los Angeles, CAUniversity Retina· Lemont, ILRetina Consultants of Texas· The Woodlands, TX

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