Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557460
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief 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 AMD GEOGRAPHIC ATROPHY
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATCH-AMD
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 31 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
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 31 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None