Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-07 @ 6:55 AM
Study NCT ID:
NCT06557460
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in retinal sensitivity', 'timeFrame': '1 year post implantation', 'description': 'Change in retinal sensitivity by microperimetry'}], 'secondaryOutcomes': [{'measure': 'Change in best corrected visual acuity', 'timeFrame': '1 year post implantation', 'description': 'Change in best corrected visual acuity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dry Age-related Macular Degeneration', 'Geographic Atrophy']}, 'descriptionModule': {'briefSummary': '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.\n\nUp 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:\n\n* The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).\n* The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligible participants include:\n\n1. Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.\n2. 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.\n3. Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.\n4. 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.\n5. 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.\n6. Medically suitable for general anesthesia or monitored intravenous sedation, if needed.\n7. Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.\n8. Participants also must be willing and able to provide written, signed informed consent for this study.\n9. Participants able to complete the baseline microperimetry retinal sensitivity testing.\n10. On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.'}, 'identificationModule': {'nctId': 'NCT06557460', 'acronym': 'PATCH-AMD', 'briefTitle': 'A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regenerative Patch Technologies, LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RPT-14-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).', 'description': 'Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).', 'interventionNames': ['Device: Surgical implantation of the CPCB-RPE1 implant']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)', 'description': 'Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)', 'interventionNames': ['Device: Surgical implantation of the CPCB-RPE1 implant']}], 'interventions': [{'name': 'Surgical implantation of the CPCB-RPE1 implant', 'type': 'DEVICE', 'description': 'Surgical implantation of the CPCB-RPE1 implant', 'armGroupLabels': ['Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).', 'Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'clinicaltrials@regenerativepatch.com', 'phone': '833-734-3678'}], 'facility': 'Retina-Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'clinicaltrials@regenerativepatch.com', 'phone': '833-734-3678'}], 'facility': 'Retina Associates of Southern California', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'clinicaltrials@regenerativepatch.com', 'phone': '833-734-3678'}], 'facility': 'USC - Keck', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'clinicaltrials@regenerativepatch.com', 'phone': '833-734-3678'}], 'facility': 'University Retina', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'clinicaltrials@regenerativepatch.com', 'phone': '833-734-3678'}], 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'centralContacts': [{'name': 'Clinical Research', 'role': 'CONTACT', 'email': 'clinicaltrials@regenerativepatch.com', 'phone': '833-734-3678'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regenerative Patch Technologies, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'California Institute for Regenerative Medicine (CIRM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}