Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-31 @ 12:05 PM
Study NCT ID:
NCT04597632
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D057135', 'term': 'Wet Macular Degeneration'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622091', 'term': 'brolucizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis 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 are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.', 'description': 'Adverse events and the death are reported in the Full Analysis Set that includes all participants who received at least one dose of study treatment in the extension study.', 'eventGroups': [{'id': 'EG000', 'title': 'Brolucizumab 6mg', 'description': 'Brolucizumab 6mg', 'otherNumAtRisk': 248, 'deathsNumAtRisk': 248, 'otherNumAffected': 58, 'seriousNumAtRisk': 248, 'deathsNumAffected': 1, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Cataract - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Eye pain - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Neovascular age-related macular degeneration - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Visual acuity reduced - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Intraocular pressure increased - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Retinal detachment - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Retinal occlusive vasculitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Uveitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vitreal cells - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vitreal cells - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': "Whipple's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Procedural vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'title': '20 weeks', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': '16 weeks', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 56', 'description': 'Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. Last interval with no disease activity (number of weeks): Number of subjects at 20/16/12/8/4-weeks intervals up to Week 56 for the study eye in the extension study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set. Subjects with at least two injections in the extension study'}, {'type': 'PRIMARY', 'title': 'Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg (Core Study)', 'description': 'Patients who received brolucizumab 6 mg in the core study and continued with the same treatment in the extension study'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg (Core Study)', 'description': 'Patients who received aflibercept 2 mg in the core study and switched to brolucizumab 6 mg in the extension study'}, {'id': 'OG002', 'title': 'Brolucizumab 6 mg (Extension Study Total)', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '8.29', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '7.33', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '7.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension study baseline, average of Week 52 and Week 56', 'description': 'Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nThe average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set - Last Observation Carried Forward. Participants were analyzed according to the originally assigned treatment arm in the core study (CRTH258A2303, NCT04005352).'}, {'type': 'SECONDARY', 'title': 'Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg (Core Study)', 'description': 'Patients who received brolucizumab 6 mg in the core study and continued with the same treatment in the extension study'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg (Core Study)', 'description': 'Patients who received aflibercept 2 mg in the core study and switched to brolucizumab 6 mg in the extension study'}, {'id': 'OG002', 'title': 'Brolucizumab 6 mg (Extension Study Total)', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '24.43', 'groupId': 'OG000'}, {'value': '-14.1', 'spread': '60.67', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '45.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension study baseline, average of Week 52 and Week 56', 'description': 'Central Subfield Thickness (μm): Analysis of Variance (ANOVA) results for the average change from extension study Baseline at Week 52 and Week 56 for the study eye in the extension study by core study treatment arm.\n\nCentral Subfield Thickness was assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with a valid measurement for the outcome measure. Participants were analyzed according to the originally assigned treatment arm in the core study (CRTH258A2303, NCT04005352).'}, {'type': 'SECONDARY', 'title': 'Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg (Core Study)', 'description': 'Patients who received brolucizumab 6 mg in the core study and continued with the same treatment in the extension study'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg (Core Study)', 'description': 'Patients who received aflibercept 2 mg in the core study and switched to brolucizumab 6 mg in the extension study'}, {'id': 'OG002', 'title': 'Brolucizumab 6 mg (Extension Study Total)', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'title': 'Week 52 IRF assessment - Present (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 IRF assessment - Absent (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 SRF assessment - Present (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 SRF assessment - Absent (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 Sub-RPE fluid - Present (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 Sub-RPE fluid - Absent (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 IRF and/or SRF - Present (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 IRF and/or SRF - Absent (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 IRF and SRF - Present (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 IRF and SRF - Absent (n=103,90,193)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 IRF assessment - Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 IRF assessment - Absent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 SRF assessment - Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 SRF assessment - Absent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 Sub-RPE fluid - Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 Sub-RPE fluid - Absent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 IRF and/or SRF - Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 IRF and/or SRF - Absent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 IRF and SRF - Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 IRF and SRF - Absent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 52 and 56', 'description': 'Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) status in the central subfield as assessed by Spectral Domain Ocular Coherence Tomography (SD-OCT): Number (%) of subjects with presence of IRF and/or SRF, and sub-Retinal Pigment Epithelium (RPE) fluid in the study eye at Week 52 and Week 56 overall and by core study treatment arm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set - 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for Subjects with at least two injections in the extension study'}, {'type': 'SECONDARY', 'title': 'Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg (Core Study)', 'description': 'Patients who received brolucizumab 6 mg in the core study and continued with the same treatment in the extension study'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg (Core Study)', 'description': 'Patients who received aflibercept 2 mg in the core study and switched to brolucizumab 6 mg in the extension study'}], 'classes': [{'title': '20 Weeks', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '16 Weeks', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': '8 Weeks', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '4 Weeks', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 56', 'description': 'Duration of the maximal intervals with no disease activity up to Week 52 by core study treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set - for Subjects with at least two injections in the extension study'}, {'type': 'SECONDARY', 'title': 'Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg (Core Study)', 'description': 'Patients who received brolucizumab 6 mg in the core study and continued with the same treatment in the extension study'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg (Core Study)', 'description': 'Patients who received aflibercept 2 mg in the core study and switched to brolucizumab 6 mg in the extension study'}], 'classes': [{'title': '16 Weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '8 Weeks', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '4 Weeks', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': '0 Weeks', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '- 4 Weeks', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '-8 Weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-12 Weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study baseline, up to Week 56', 'description': 'Change in last interval with no disease activity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set - for Subjects with at least two injections in the extension study'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'title': 'Number of subjects with at least one AE', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Cataract', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Eye pain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Visual acuity reduced', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Intraocular pressure increased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Retinal haemorrhage', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Ocular discomfort', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Vitreous floaters', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'title': 'Number of subjects with at least one AE', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'COVID-19', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Basal cell carcinoma', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'classes': [{'title': 'On-treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On-treatment death reporting - from first dose until 30 days after last dose for a maximum timeframe of approximately 56 weeks. Post-treatment death reporting - greater than 30 days after the last dose of study drug.', 'description': 'On treatment death monitoring occurred after the first dose of study drug in the extension study until 30 days after the last administration of study drug for a maximum timeframe of approximately 56 weeks. Post-treatment death monitoring occurred greater than 30 days after the last administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analyses Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brolucizumab 6 mg (Extension Study Total)', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brolucizumab 6 mg (Extension Study Total)', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.9', 'spread': '7.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '219', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', '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': '61', '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': '187', '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'}], 'populationDescription': 'Full Analysis Set composed of all subjects who received at least one dose of study treatment in the extension study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-20', 'size': 1035747, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-27T09:23', 'hasProtocol': True}, {'date': '2023-05-05', 'size': 534840, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-27T09:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2020-10-01', 'resultsFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-02', 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye', 'timeFrame': 'Up to Week 56', 'description': 'Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. Last interval with no disease activity (number of weeks): Number of subjects at 20/16/12/8/4-weeks intervals up to Week 56 for the study eye in the extension study'}, {'measure': 'Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye', 'timeFrame': 'Extension study baseline, average of Week 52 and Week 56', 'description': 'Best-Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nThe average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values.'}], 'secondaryOutcomes': [{'measure': 'Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye', 'timeFrame': 'Extension study baseline, average of Week 52 and Week 56', 'description': 'Central Subfield Thickness (μm): Analysis of Variance (ANOVA) results for the average change from extension study Baseline at Week 52 and Week 56 for the study eye in the extension study by core study treatment arm.\n\nCentral Subfield Thickness was assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.'}, {'measure': 'Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm', 'timeFrame': 'Weeks 52 and 56', 'description': 'Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) status in the central subfield as assessed by Spectral Domain Ocular Coherence Tomography (SD-OCT): Number (%) of subjects with presence of IRF and/or SRF, and sub-Retinal Pigment Epithelium (RPE) fluid in the study eye at Week 52 and Week 56 overall and by core study treatment arm'}, {'measure': 'Last Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study by Core Study Randomized Treatment Arm', 'timeFrame': 'up to Week 56', 'description': 'Duration of the last interval with no disease activity up to Week 52 by core study treatment arm.'}, {'measure': 'Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study', 'timeFrame': 'up to Week 56', 'description': 'Duration of the maximal intervals with no disease activity up to Week 52 by core study treatment arm.'}, {'measure': 'Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm', 'timeFrame': 'Extension study baseline, up to Week 56', 'description': 'Change in last interval with no disease activity'}, {'measure': 'Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye', 'timeFrame': 'Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.'}, {'measure': 'Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term', 'timeFrame': 'Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neovascular age-related macular degeneration', 'wet age-related macular degeneration', 'wet AMD', 'choroidal neovascularization', 'individualized treatment', 'anti-VEGF', 'Macular degeneration', 'age-related macular degeneration (ARMD)', 'vision loss', 'macula damage', 'retina damage', 'dry macular degeneration', 'wet macular degeneration', 'Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1913', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': "The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks.\n\nAll eligible participants were treated with brolucizumab regardless of their treatment in the TALON study.\n\nThe study period was 56 weeks including post-treatment follow-up.", 'detailedDescription': "This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.\n\nThe maximum study duration for a subject was 56 weeks, including post-treatment follow-up.\n\nThere were two periods in this study:\n\n* Treat-to-Control treatment period: from Baseline (Day 1) to Week 52\n* Post-treatment follow-up period: from Week 52 to Week 56.\n\nAll participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).\n\nTreatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent\n2. Successfully completed TALON core study at week 64 (End of Study)\n\nExclusion Criteria:\n\n1. Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator\n2. Discontinued study treatment in the core study\n3. Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.\n4. Pregnant or nursing (lactating) women\n5. Women of child-bearing potential not using highly effective methods of contraception"}, 'identificationModule': {'nctId': 'NCT04597632', 'acronym': 'TALON Ext', 'briefTitle': 'An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study', 'orgStudyIdInfo': {'id': 'CRTH258A2303E1'}, 'secondaryIdInfos': [{'id': '2020-002349-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brolucizumab 6 mg', 'description': "Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. 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