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)

Phase 2

Not yet recruiting

• Conditions: Dry Age-related Macular Degeneration; Geographic Atrophy
• Interventions: Device: Surgical implantation of the CPCB-RPE1 implant

• Registration Number: NCT06557460
• Lead Sponsor: Regenerative Patch Technologies, LLC

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 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Study Start: 2024-10
• Primary Completion: 2027-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).	Surgical implantation of the CPCB-RPE1 implant	Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)	Surgical implantation of the CPCB-RPE1 implant	Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Primary Outcome Measures

Name	Time	Method
Change in retinal sensitivity	1 year post implantation	Change in retinal sensitivity by microperimetry

Secondary Outcome Measures

Name	Time	Method
Change in best corrected visual acuity	1 year post implantation	Change in best corrected visual acuity