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) (PATCH-AMD)

Regenerative Patch Technologies

Status and phase: Not yet enrolling; Phase 2

Conditions: Geographic Atrophy; Dry Age-related Macular Degeneration

Treatments: Device: Surgical implantation of the CPCB-RPE1 implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06557460

RPT-14-02

Details and patient eligibility

About

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)

Enrollment: 24 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligible participants include:

1. Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
2. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 10.0 mm2 of geographic atrophy involving the fovea.
3. Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
4. 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.
5. Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required.
6. Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
7. Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
8. Participants also must be willing and able to provide written, signed informed consent for this study.
9. Participants able to complete the baseline microperimetry retinal sensitivity testing.
10. On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).

Experimental group

Description:

Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).

Treatment:

Device: Surgical implantation of the CPCB-RPE1 implant

Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Sham Comparator group

Description:

Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Treatment:

Device: Surgical implantation of the CPCB-RPE1 implant