Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT06087458
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2023-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Central Reading Center is masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase 1 follows a standard dose escalation model to evaluate safety and tolerability of VOY-101 and recommended Phase 2a dose (RP2D). This dose will be used in Phase 2a to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall effect of treatment on retinal structural health', 'timeFrame': 'Week 48', 'description': 'GA growth rate and Change in Ellipsoid Zone Integrity'}], 'secondaryOutcomes': [{'measure': 'Overall effect of treatment on retinal structural health', 'timeFrame': 'Weeks 36, 48, and 96', 'description': 'GA Growth Rate and Change in Ellipsoid Zone Integrity'}, {'measure': 'Effect of treatment on vision function', 'timeFrame': 'Change from baseline', 'description': 'Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and LLVA and microperimetry.'}, {'measure': 'Incidence of neovascular AMD', 'timeFrame': 'Baseline to Week 96', 'description': 'Incidence, frequency, severity, and timing of development of neovascular AMD'}, {'measure': 'VOY-101 Safety', 'timeFrame': 'Baseline to Week 96', 'description': 'Frequency of related ocular and systemic AEs (SAEs and non-serious), adverse events of special interest (AESI) and non-serious TEAEs).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration', 'Geographic Atrophy', 'Non-neovascular AMD']}, 'descriptionModule': {'briefSummary': 'The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.', 'detailedDescription': 'This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of escalating dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are ≥60 years of age at the time of consent.\n* Are willing and able to understand and provide written informed consent.\n* Are willing and able to return for scheduled treatment and follow-up examinations.\n* Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.\n* Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV for both eyes.\n* Absence of signs of non-exudative MNV.\n* Additional Ocular Inclusion Criteria for both eyes.\n* Meet certain genotype criteria for risk of AMD.\n\nExclusion Criteria:\n\n* Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.\n* Additional Systemic, Ocular, and Genetic Exclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT06087458', 'acronym': 'JOURNEY', 'briefTitle': 'Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perceive Biotherapeutics, Inc.'}, 'officialTitle': 'Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non- Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'PBI-AMD-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOY-101', 'description': 'Single intravitreal injection of VOY-101', 'interventionNames': ['Biological: VOY-101']}, {'type': 'NO_INTERVENTION', 'label': 'Controll', 'description': 'Fellow Eye'}], 'interventions': [{'name': 'VOY-101', 'type': 'BIOLOGICAL', 'description': 'VOY-101', 'armGroupLabels': ['VOY-101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Macula Institute of AZ', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Retina Partners', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92064', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '76028', 'city': 'Burleson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Star Retina', 'geoPoint': {'lat': 32.54208, 'lon': -97.32085}}, {'zip': '76092', 'city': 'Southlake', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Center of Texas', 'geoPoint': {'lat': 32.94124, 'lon': -97.13418}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Utah John A. Moran Eye Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Sydney Retina Clinic and Day Surgery', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Cerulea Clinical Trials', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '64239', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center, Ophthalmology Division', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Anne Fung, MD', 'role': 'CONTACT', 'email': 'Voy101clinical@perceivebio.com', 'phone': '(800) 867-7960'}], 'overallOfficials': [{'name': 'Anne Fung, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Perceive Biotherapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perceive Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}