A Phase 2b, Randomized, Assessor-Masked Clinical Trial to Assess the Safety and Efficacy of the CPCB-RPE1 Implant in Subjects with Geographic Atrophy
Grant Award Details
Grant Type:
Grant Number:
CLIN2-14787
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$12,373,748
Status:
Active
Grant Application Details
Application Title:
A Phase 2b, Randomized, Assessor-Masked Clinical Trial to Assess the Safety and Efficacy of the CPCB-RPE1 Implant in Subjects with Geographic Atrophy
Public Abstract:
Therapeutic Candidate or Device
A patch comprised of a layer of stem cell-derived retinal pigmented epithelial (RPE) cells on a supporting matrix that is implanted under the retina
Indication
Geographic atrophy, the late-stage form of age-related macular degeneration
Therapeutic Mechanism
The healthy RPE cells on the implant replace dying RPE cells in the eye that are the cause of geographic atrophy. This promotes survival of the cells of the adjacent retina.
Unmet Medical Need
There are currently no therapeutics that are effective in improving vision in geographic atrophy
Project Objective
Completion of Phase 2b clinical trial
Major Proposed Activities
A patch comprised of a layer of stem cell-derived retinal pigmented epithelial (RPE) cells on a supporting matrix that is implanted under the retina
Indication
Geographic atrophy, the late-stage form of age-related macular degeneration
Therapeutic Mechanism
The healthy RPE cells on the implant replace dying RPE cells in the eye that are the cause of geographic atrophy. This promotes survival of the cells of the adjacent retina.
Unmet Medical Need
There are currently no therapeutics that are effective in improving vision in geographic atrophy
Project Objective
Completion of Phase 2b clinical trial
Major Proposed Activities
- Manufacture of the cryopreserved formulation of the CPCB-RPE1 implant for use in the Phase IIb clinical trial
- Completion of a multi-center, randomized Phase IIb clinical trial testing the efficacy and safety of the CPCB-RPE1 implant in geographic atrophy
Statement of Benefit to California:
It is estimated that over 400,000 Californians will develop advanced forms of age-related macular degeneration over the next 10 years. AMD has devastating consequences including loss
of independence and productivity, and increased injuries. The financial impact is estimated to be $3 billion annually in California. CPCB-RPE1 is being developed in California by a
California based company providing potential treatments and jobs to Californians.