A Phase I/IIa Safety Study of Subretinal Implantation of CPCB-RPE1 (Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells Seeded on a Polymeric Substrate) in Subjects With Advanced, Dry Age-Related Macular Degeneration (AMD)
Sponsor study identifier
interventional
16
1 country
6
Study Start
February 16, 2016
Actual (reported)Primary Completion
July 2019
Actual (reported)Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety of Human Embryonic Stem Cell-Derived RPE Cells on a parylene membrane (CPCB-RPE1) in patients with advanced, dry age-related macular degeneration. Primary Objective:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2015
Actual (reported)October 29, 2015
Actual (reported)February 16, 2016
Actual (reported)July 2019
Actual (reported)June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Frequency and Severity of Treatment-Related Adverse Events [Safety and Tolerability]
Comparison of product, procedure and immunosuppression related adverse events in the implanted eye to those experienced in the non-treated eye
1 year
Visual Acuity
1 year
Visual Field
1 year
Photoreceptor Electrical Responses
1 year
Subretinal implantation of CPCB-RPE1 in dry AMD patients
Patients will receive one CPCB-RPE1 implant of approximately 100,000 differentiated RPE cells attached to a small parylene membrane. The density of cells on the membrane represents the approximate density of RPE cells in the human eye. The membrane size was chosen to cover a substantial portion of the macular region of the retina.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Retinal Consultants of Arizona LTD
Phoenix, Arizona, 85053, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
USC Keck School of Medicine / Eye Institute
Los Angeles, California, 90033, United States
Southern California Desert Retina Consultants
Palm Desert, California, 92211, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Jane Lebkowski, Ph.D.
Regenerative Patch Technologies
16 participants (actual enrollment reported by the registry).
First Submitted
October 23, 2015
First Posted
October 29, 2015
Study Start
February 16, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 2019
Actual (reported)Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 29, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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