Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT04632056
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622091', 'term': 'brolucizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events in the eyes on therapy', 'timeFrame': '52 weeks', 'description': 'Number of patients with adverse events (AEs) in the eyes on therapy were reported'}, {'measure': 'Number of patients with adverse events in other parts of the body (non-ocular)', 'timeFrame': '52 weeks', 'description': 'Number of patients with adverse events (AEs) in other parts of the body (non-ocular) were reported'}], 'secondaryOutcomes': [{'measure': 'Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy', 'timeFrame': '52 weeks', 'description': 'A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.\n\nAn adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.'}, {'measure': 'Number of patients with SAEs and ADRs in other parts of the body (non-ocular)', 'timeFrame': '52 weeks', 'description': 'A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.\n\nAn adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.'}, {'measure': 'Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications', 'timeFrame': '52 weeks', 'description': 'The following events were chosen as the safety specifications for this study that should be investigated:\n\n* Intraocular inflammation\n* Endophthalmitis\n* Increased intraocular pressure\n* Retinal pigment epithelial tear\n* Retinal detachment and retinal tear\n* Retinal artery embolic events\n* Non-ocular arterial thromboembolic events\n* Retinal vasculitis and retinal vascular occlusion'}, {'measure': 'Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)', 'timeFrame': '52 weeks', 'description': 'Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) were reported'}, {'measure': 'Proportion of patients with visual acuity (VA) worsening', 'timeFrame': '52 weeks', 'description': 'Visual acuity commonly refers to the clarity of vision'}, {'measure': 'Data on Beovu administration in the induction phase and maintenance phase', 'timeFrame': '52 weeks', 'description': 'For data on Beovu administration (dosing duration, dosing frequency) in the primary treated eye and the secondary primary eyes in the safety analysis set, summary statistics were calculated respectively. The same calculation applied to data on administration respectively for the induction period and the maintenance period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Japan', 'brolucizumab', 'neovascular age-related macular degeneration', '(nAMD)', 'non-interventional study', 'post-marketing surveillance'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18111', 'label': 'Results for CRTH258A1401 that is getting linked from the Novartis Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.', 'detailedDescription': 'The observational period was 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye.\n\nHowever, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. This was set in order to collect data as much as possible based on the clinical effect of the drug. If 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient was to be monitored for adverse events until 30 days after the last dose of this drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population was patients using Beovu kit for intravitreal injection for nAMD with subfoveal CNV', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection\n2. Patients using Beovu kit for intravitreal injection for the first time for the following indication:\n\n * Indication: age-related macular degeneration with subfoveal choroidal neovascularization\n\nExclusion Criteria:\n\n1\\. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as Beovu kit for intravitreal injection'}, 'identificationModule': {'nctId': 'NCT04632056', 'briefTitle': 'A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)', 'orgStudyIdInfo': {'id': 'CRTH258A1401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Beovu', 'description': 'Brolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks', 'interventionNames': ['Drug: Beovu']}], 'interventions': [{'name': 'Beovu', 'type': 'DRUG', 'otherNames': ['Brolucizumab'], 'description': 'There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled.', 'armGroupLabels': ['Beovu']}]}, 'contactsLocationsModule': {'locations': [{'zip': '456-0032', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '457 8510', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '460-0008', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '462-0825', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466 8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis 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'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}