Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
Study NCT ID:
NCT06556368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2024-08-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized 1:1:1 into one of three treatment groups: tarcocimab-ted, tabirafusp-ted or aflibercept.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 675}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity (BCVA)', 'timeFrame': 'Week 48', 'description': 'Mean change in BCVA from Day 1 to Year 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wet AMD', 'KSI-301', 'KSI-501', 'Tarcocimab', 'Tabirafusp', 'Aflibercept', 'Antibody biopolymer conjugate', 'AMD', 'Anti-VEGF', 'Vascular endothelial growth factor', 'Kodiak Sciences'], 'conditions': ['Wet Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening\n* BCVA ETDRS score between 78 and 25 letters (Snellen equivalent \\~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)\n* Fibrosis or atrophy of \\>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening'}, 'identificationModule': {'nctId': 'NCT06556368', 'acronym': 'DAYBREAK', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kodiak Sciences Inc'}, 'officialTitle': 'A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)', 'orgStudyIdInfo': {'id': 'KS301P109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tarcocimab tedromer 5 mg (KSI-301)', 'description': 'Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.', 'interventionNames': ['Drug: Tarcocimab tedromer']}, {'type': 'EXPERIMENTAL', 'label': 'Tabirafusp tedromer 5 mg (KSI-501)', 'description': 'Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)', 'interventionNames': ['Drug: Tabirafusp tedromer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept 2 mg', 'description': 'Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing', 'interventionNames': ['Drug: Aflibercept']}], 'interventions': [{'name': 'Tarcocimab tedromer', 'type': 'DRUG', 'otherNames': ['KSI-301'], 'description': 'Intravitreal injection', 'armGroupLabels': ['Tarcocimab tedromer 5 mg (KSI-301)']}, {'name': 'Tabirafusp tedromer', 'type': 'DRUG', 'otherNames': ['KSI-501'], 'description': 'Intravitreal injection', 'armGroupLabels': ['Tabirafusp tedromer 5 mg (KSI-501)']}, {'name': 'Aflibercept', 'type': 'DRUG', 'otherNames': ['Eylea'], 'description': 'Intravitreal injection', 'armGroupLabels': ['Aflibercept 2 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Macula Institute of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Associates SW', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92835', 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