A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical implantation of the CPCB-RPE1 implant.
- Who it may be relevant to
- Registry conditions: Dry Age-related Macular Degeneration, Geographic Atrophy. Basic parameters: 55 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Subjects With Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) - PATCH AMD
Overview
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)
Interventions
- Device Surgical implantation of the CPCB-RPE1 implant
Surgical implantation of the CPCB-RPE1 implant
Primary outcome measures
- Change in retinal sensitivity [Time frame: 1 year post implantation]
Secondary outcome measures (1)
- Change in best corrected visual acuity [Time frame: 1 year post implantation]
Eligibility criteria
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 15.0 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Retina Associates of Southern California — Huntington Beach
- USC - Keck — Los Angeles
- University Retina — Lemont
- Retina Consultants of Texas — The Woodlands
Identifiers
NCT: NCT06557460 · RPT-14-02