Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT05282004
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2022-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Sandoz' agreements with its investigators may vary. However, Sandoz does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the study for 31 days', 'description': 'Any signs or symptoms were collected throughout the study for 31 days', 'eventGroups': [{'id': 'EG000', 'title': 'SOK583A1 40 mg/mL', 'description': 'SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 17, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}], 'seriousEvents': [{'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Ocular Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOK583A1 40 mg/mL', 'description': 'SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '31 days', 'description': 'Number of participants with ocular treatment emergent adverse events were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): FAS included all participants who received an injection of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Non-ocular Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOK583A1 40 mg/mL', 'description': 'SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '31 days', 'description': 'Number of participants with non-ocular treatment emergent adverse events were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): FAS included all participants who received an injection of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOK583A1 40 mg/mL', 'description': 'SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 5 study sites in the USA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SOK583A1 40 mg/mL', 'description': 'SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'spread': '8.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-14', 'size': 462362, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-17T08:17', 'hasProtocol': True}, {'date': '2021-12-14', 'size': 315049, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-17T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2022-03-07', 'resultsFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-17', 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Ocular Treatment Emergent Adverse Events', 'timeFrame': '31 days', 'description': 'Number of participants with ocular treatment emergent adverse events were reported.'}, {'measure': 'Number of Participants With Non-ocular Treatment Emergent Adverse Events', 'timeFrame': '31 days', 'description': 'Number of participants with non-ocular treatment emergent adverse events were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open label study,', 'intravitreal injection,', 'biosimilar,', 'aflibercept,', 'vial kit'], 'conditions': ['Neovascular Age-related Macular Degeneration (nAMD)']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.', 'detailedDescription': 'Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their routine treatment scheme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 50 years of age at baseline\n* Patients diagnosed with nAMD (uni- or bilateral)\n* Patients already under IVT Eylea treatment (last injection of the induction period or maintenance phase)\n* Willing and able to comply with all study procedures, and be likely to complete the study\n* Signed informed consent must be obtained before any assessment is performed\n\nExclusion Criteria:\n\n* Active, suspected or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis\n* Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP ≥ 26 mmHg, despite treatment with anti-glaucomatous medication)\n* History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product\n* Visual acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness\n* Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening\n* Systemic treatment with long-acting corticosteroids (more than 10 mg prednisolone equivalent) within 3 months prior to screening Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol\n* Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye any time during the past 3 months\n* Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment\n* Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening)\n* Participants who do not comply with the local COVID-19 regulations of the study site"}, 'identificationModule': {'nctId': 'NCT05282004', 'briefTitle': 'Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Vial Kit', 'orgStudyIdInfo': {'id': 'CSOK583A12303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOK583A1', 'description': 'SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)', 'interventionNames': ['Drug: SOK583A1']}], 'interventions': [{'name': 'SOK583A1', 'type': 'DRUG', 'description': 'SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)', 'armGroupLabels': ['SOK583A1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60452', 'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}, {'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}