A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-90
SponsorRegenerative Patch Technologies, LLC
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Surgical implantation of the CPCB-RPE1 implant
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Regenerative Patch Technologies, LLC
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
Source ClinicalTrials.gov