Dry Age-related Macular DegenerationPhase 2PATCH-AMDNCT06557460
A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
A Phase 2 study testing Surgical implantation of the CPCB-RPE1 implant in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Regenerative Patch Technologies, LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Dry Age-related Macular Degeneration, Geographic Atrophy
- What is being tested?
- Surgical implantation of the CPCB-RPE1 implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2025to Dec 2040
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligible participants include:
- Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
- 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.
- Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
- 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.
- 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.
- Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
- Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
- Participants also must be willing and able to provide written, signed informed consent for this study.
- Participants able to complete the baseline microperimetry retinal sensitivity testing.
- On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Austin Retina Associates
Austin, Texas, 78705
Clinical Research, 833-734-3678, clinicaltrials@regenerativepatch.com
Clinical Research, 650-394-5835
- Recruiting
Retina Associates of Southern California
Huntington Beach, California, 92647
833-734-3678, clinicaltrials@regenerativepatch.com
- Recruiting
University Retina
Lemont, Illinois, 60439
833-734-3678, clinicaltrials@regenerativepatch.com
- Recruiting
USC - Keck
Los Angeles, California, 90033
833-734-3678, clinicaltrials@regenerativepatch.com
- Recruiting
Retina Consultants of Texas
The Woodlands, Texas, 77384
833-734-3678, clinicaltrials@regenerativepatch.com
About this study
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
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)
- Being tested
- Surgical implantation of the CPCB-RPE1 implant
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical implantation of the CPCB-RPE1 implantDevice
Surgical implantation of the CPCB-RPE1 implant
| Study group | Role | What they receive |
|---|---|---|
| Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). | Experimental | Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). Receives: Device: Surgical implantation of the CPCB-RPE1 implant |
| Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) | Sham comparator | Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) Receives: Device: Surgical implantation of the CPCB-RPE1 implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal sensitivity
Change in retinal sensitivity by microperimetry
Measured: 1 year post implantation
Secondary outcomes (1)
Change in best corrected visual acuity
Change in best corrected visual acuity
Measured: 1 year post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regenerative Patch Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557460
- Sponsor's protocol ID
- RPT-14-02
- Acronym
- PATCH-AMD
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06557460
- Acronym / sponsor ID
- PATCH-AMD / RPT-14-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Regenerative Patch Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). | Experimental | Device: Surgical implantation of the CPCB-RPE1 implantActive treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). |
| Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) | Sham comparator | Device: Surgical implantation of the CPCB-RPE1 implantControl group receiving a simulated "sham" implantation procedure (up to 6 subjects) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical implantation of the CPCB-RPE1 implantSurgical implantation of the CPCB-RPE1 implant | Device | Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects)., Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) |
Primary outcome
Change in retinal sensitivity
Time frame: 1 year post implantation
Change in retinal sensitivity by microperimetry
1 secondary outcome
Change in best corrected visual acuity
Time frame: 1 year post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Research contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical implantation of the CPCB-RPE1 implant in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Regenerative Patch Technologies, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research (833-734-3678, clinicaltrials@regenerativepatch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in retinal sensitivity (time frame: 1 year post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.