CPCB-RPE1 Implant for Age-Related Macular Degeneration

(PATCH-AMD Trial)

Recruiting at 4 trial locations

Overseen By Clinical Research

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regenerative Patch Technologies, LLC

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implant called CPCB-RPE1 to determine its effectiveness for people with advanced dry age-related macular degeneration (AMD), specifically those with geographic atrophy affecting the fovea, a crucial part of the eye for sharp vision. The trial aims to assess the implant's safety and effectiveness compared to a simulated procedure, which serves as a control. Participants will be divided into two groups: one receiving the real implant and the other undergoing the sham procedure. This trial may suit individuals with advanced dry AMD who have significant vision loss in one eye but retain some vision. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CPCB-RPE1 implant is safe for age-related macular degeneration?

Research has shown that the CPCB-RPE1 implant is safe and well-tolerated. In one study, after one year, the implant proved safe for individuals with advanced dry age-related macular degeneration, a condition that causes vision loss. Another study found that even after three years, the implant remained safe for patients. This suggests the treatment is well-tolerated over time. These studies offer a positive indication for potential participants regarding the safety of the CPCB-RPE1 implant. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for age-related macular degeneration?

Researchers are excited about the CPCB-RPE1 implant for age-related macular degeneration (AMD) because it represents a novel approach to treating this condition. Unlike current treatments, which typically involve injections of drugs like anti-VEGF therapies to slow vision loss, the CPCB-RPE1 implant uses a cell-based method, potentially offering a more durable solution. This implant aims to replace damaged retinal cells with healthy ones, which could restore vision rather than just maintaining it. This innovative approach has the potential to fundamentally change how we address AMD by targeting the underlying cause of vision loss instead of just managing symptoms.

What evidence suggests that the CPCB-RPE1 implant is effective for age-related macular degeneration?

Research has shown that the CPCB-RPE1 implant, which participants in this trial may receive, could help treat geographic atrophy, a condition related to age-related macular degeneration. One study found that 27% of recipients improved their vision by more than 5 letters on an eye chart, a significant improvement for those with this condition. Long-term follow-up has indicated that the implant remains safe and well-tolerated over several years. The implant uses cells from human embryonic stem cells to replace damaged retinal cells, which are crucial for vision. These early results suggest that the CPCB-RPE1 implant may help slow vision loss in affected individuals. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people aged 55 to 90 with advanced dry age-related macular degeneration (AMD) and geographic atrophy involving the fovea. Participants must have certain levels of visual acuity, be medically fit for surgery under anesthesia, and able to follow post-op instructions. Those with cataracts are excluded.

Inclusion Criteria

I am willing and able to sign the consent form for this study.

I am medically cleared to undergo anesthesia if required.

I have been diagnosed with geographic atrophy through eye exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CPCB-RPE1 implant or a simulated 'sham' procedure

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CPCB-RPE1

Trial Overview The study tests a surgical implant called CPCB-RPE1 in patients with AMD. It's randomized: some get the real implant while others get a 'sham' procedure without actual treatment. The goal is to see if the implant improves vision or slows down disease progression.

How Is the Trial Designed?

Group I: Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). Experimental Treatment 1 Intervention

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

Group II: Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Regenerative Patch Technologies, LLC

Lead Sponsor

Trials

2

Recruited

40+

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials

70

Recruited

3,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8496407/

One-Year Follow-Up in a Phase 1/2a Clinical Trial of an ... Preliminary signals of efficacy included improvement of BCVA by >5 letters in 27% of implanted subjects, despite the large extent of retinal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02590692

NCT02590692 | Study of Subretinal Implantation of Human ... To assess visual acuity, visual field, and retinal function after CPCB-RPE1 implantation. Implanted and fellow eyes will be compared post-implantation to assess ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642023009351

Long-term Follow-up of a Phase 1/2a Clinical Trial ... Results show that the implant, at a median 3-year follow-up, is safe and well tolerated in patients with advanced dry age-related macular degeneration.

4. europe.ophthalmologytimes.com europe.ophthalmologytimes.com/view/subretinal-implant-for-advanced-dry-amd-determined-to-be-safe-well-tolerated

Subretinal implant for advanced dry AMD determined to be ... This study showed that an investigational subretinal implant, CPCB-RPE1, containing allogeneic human embryonic stem cell-derived RPE cells, was safe and well- ...

5. cirm.ca.gov cirm.ca.gov/our-progress/awards/phase-2b-randomized-assessor-masked-clinical-trial-assess-safety-and-efficacy-cpcb-rpe1-implant-subjects-geographic-atrophy/

A Phase 2b, Randomized, Assessor-Masked Clinical Trial to ... A Phase 2b, Randomized, Assessor-Masked Clinical Trial to Assess the Safety and Efficacy of the CPCB-RPE1 Implant in Subjects with Geographic Atrophy.

6. cirm.ca.gov cirm.ca.gov/our-progress/awards/phase-1-safety-assessment-cpcb-rpe1-hesc-derived-rpe-cell-coated-parylene-membrane-implants-patients-advanced-dry-age-related-macular-degeneration/

Phase 1 Safety Assessment of CPCB-RPE1, hESC-derived ... Phase 1 Safety Assessment of CPCB-RPE1, hESC-derived RPE Cell Coated Parylene Membrane Implants, in Patients with Advanced Dry Age Related Macular Degeneration.