ClinicalTrials.gg
RecruitingNCT06557460PATCH-AMDUpdated Sep 23, 2026

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A Phase 2 interventional study of Surgical implantation of the CPCB-RPE1 implant in Dry Age-related Macular Degeneration and Geographic Atrophy, sponsored by Regenerative Patch Technologies, LLC. Recruiting at 5 sites in United States. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Regenerative Patch Technologies, LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 46 under way, 5 of them phase 3. Geographic Atrophy · United States.

Planned enrollment
85th of 107
24 · median 98
Started
2025
with 19 others
Phase 2
43 of 131
11 open now
Primary completion
2027-12
later than 20 of 45 live
Registered
101st of 131
by date

Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 85th largest by planned enrollment of the 107 interventional ones, is one of 20 that started in 2025, is one of 43 in phase 2, reaches primary completion later than 20 of the 45 other live ones, and was the 101st registered.

By phase

131 studies; the count open now beside each. This study's row is marked.

Phase 2this study43 · 11 open
Observational24 · 7 open
Phase 1/217 · 7 open
Phase 116 · 3 open
Phase 315 · 2 open
No phase11 · 4 open
Phase 2/35 · 1 open

By the year they started

First in 2000; this study’s year is marked. 20 started in 2025.

Size and results

Median enrollment 98 across the 107 interventional studies, 138 across the 24 observational. Of the 78 that completed or were terminated, 40 (51%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 131 studies in Geographic Atrophy with a site in United States, or all of them as a file.
02

Study 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)
03

Conditions studied

  • Dry Age-related Macular Degeneration
  • Geographic Atrophy

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04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 15.0 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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

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

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

    Device: Surgical implantation of the CPCB-RPE1 implant

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

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

    Device: Surgical implantation of the CPCB-RPE1 implant

Interventions

  • DeviceSurgical implantation of the CPCB-RPE1 implant

    Surgical implantation of the CPCB-RPE1 implant

06

What researchers measure

Primary outcomes

  1. Change in retinal sensitivity

    Change in retinal sensitivity by microperimetry

    Time frame: 1 year post implantation

Secondary outcomes

  1. Change in best corrected visual acuity

    Change in best corrected visual acuity

    Time frame: 1 year post implantation

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Dec 2027, 28 months after the start.

Of 24 phase 2 interventional studies under Geographic Atrophy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 54. This study's planned 28 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2024
First posted
Aug 16, 2024
StartActual
Aug 1, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2040
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06557460
Lead sponsor
Regenerative Patch Technologies, LLC
Collaborators
California Institute for Regenerative Medicine (CIRM)
Responsible party
Sponsor
First posted
Aug 16, 2024
Start date
Aug 1, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2040 (estimated)
Last update
Sep 23, 2026

Study contacts

Clinical Research
Contact
clinicaltrials@regenerativepatch.com
833-734-3678
Clinical Research
Contact
650-394-5835

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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