A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
- Conditions
- Dry Age-related Macular DegenerationGeographic Atrophy
- Registration Number
- NCT06557460
- Lead Sponsor
- Regenerative Patch Technologies, LLC
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in retinal sensitivity 1 year post implantation Change in retinal sensitivity by microperimetry
- Secondary Outcome Measures
Name Time Method Change in best corrected visual acuity 1 year post implantation Change in best corrected visual acuity
Trial Locations
- Locations (5)
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
Retina-Vitreous Associates Medical Group🇺🇸Beverly Hills, California, United States