Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-01 @ 5:48 PM
Study NCT ID:
NCT04679935
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D057135', 'term': 'Wet Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}]}, '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 first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 26, 'seriousNumAtRisk': 27, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anterior chamber cell- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blepharitis- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cataract- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cataract- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Chalazion- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Conjunctival haemorrhage- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Conjunctival hyperaemia- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Conjunctival irritation- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Conjunctivitis allergic- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Corneal epithelial microcysts- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Corneal erosion- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Detachment of retinal pigment epithelium- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dry eye- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eczema eyelids- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eczema eyelids- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Episcleritis- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eye inflammation- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eye inflammation- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eye irritation- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eye pain- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eye ulcer- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Foreign body sensation in eyes- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Macular oedema- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Macular oedema- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Neovascular age-related macular degeneration- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Neovascular age-related macular degeneration- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ocular hyperaemia- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Posterior capsule opacification- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal aneurysm- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal aneurysm- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal cyst- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal exudates- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal exudates- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal haemorrhage- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal oedema- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal oedema- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal vasculitis- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinopathy hypertensive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Scleritis- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Subretinal fibrosis- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Subretinal fluid- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Subretinal fluid- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vision blurred- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Visual acuity reduced- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Visual acuity reduced- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Visual acuity reduced- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreal cells- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreous detachment- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreous floaters- Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreous floaters- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreous haemorrhage- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreous opacities- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tooth impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Application site wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Injection site pain- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retention cyst- Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Conjunctivitis- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hordeolum- Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Chromophobe renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ballismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Week 40', 'categories': [{'measurements': [{'value': '3.24', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '3.88', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '3.12', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '-2.23', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '2.76', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.74', 'ciLowerLimit': '-7.47', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.84', 'groupDescription': 'Week 40', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis was purely descriptive.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.15', 'ciLowerLimit': '-8.78', 'ciUpperLimit': '-0.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30', 'groupDescription': 'Week 44', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis was purely descriptive.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.35', 'ciLowerLimit': '-10.13', 'ciUpperLimit': '-0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.38', 'groupDescription': 'Week 48', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis was purely descriptive.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.19', 'ciLowerLimit': '-8.77', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Week 52', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis was purely descriptive.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.36', 'ciLowerLimit': '-8.56', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.09', 'groupDescription': 'Mean of Week 40 to Week 52', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis was purely descriptive.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set - included all patients with a valid assessment without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Treatment Intervals Before and During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'within 24 weeks prior to baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '152.0'}, {'value': '68.5', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '165.0'}]}]}, {'title': 'from baseline to week 52 (n=23,25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '85.3'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '85.8'}]}]}, {'title': 'Last treatment interval during the study (n=25,25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '88.0'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '91.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-24 Weeks, Baseline, Week 52', 'description': 'Treatment interval distribution.\n\nTreatment interval during the study, within 24 weeks prior to baseline and interval between the last 2 injections in the study. In the loading arm, data from the loading period was excluded.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Prolonged Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'from baseline to week 52', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Last treatment interval during the study', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 52', 'description': 'Treatment interval distribution.\n\nProlongation was calculated by comparing the mean treatment interval in last 24 weeks prior to first brolucizumab injection (a) with the mean of the average treatment interval during the study (loading phase excluded in the loading arm) and (b) with the last treatment interval during the study. Patients with only 1 injection during the treatment period were calculated as non-responders (no prolon-gation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set - included all patients with a valid assessment without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Maintained on q12w Regimen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 52', 'description': 'Treatment interval distribution up to Week 52.\n\nProportion of patients maintained on q12w treatment frequency in the two brolucizumab groups up to week 52. Patients who discontinued treatment before week 52 were rated as non-responders, i.e., as patients who did not maintain the q12w regimen. In the loading arm, the loading period up to week 12 was not considered in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Distribution of Patients at Every 8 Weeks / Every 12 Weeks Intervals - Frequency of Switches in Treatment Intervals Between Baseline and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Switch q12w to q8w (overall)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Switch q8w to q12w (overall)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 52', 'description': 'Treatment interval distribution', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Mean Change in Best-corrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '72.0', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '71.6', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Mean of weeks 16 to 28', 'categories': [{'measurements': [{'value': '74.9', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '71.2', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '74.8', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '16.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 16 to 28, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'BCVA ≥ 5 ETDRS letters improvement during the study', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'BCVA ≥ 10 ETDRS letters improvement during the study', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'BCVA ≥ 15 ETDRS letters improvement during the study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Best-corrected Visual Acuity >= 69 Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'LS Mean Change in Best-corrected Visual Acuity From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.19', 'ciLowerLimit': '-8.77', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'groupDescription': 'Week 52', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Analysis was purely descriptive.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set - included all patients with a valid assessment without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-74.0', 'groupId': 'OG000', 'lowerLimit': '-275', 'upperLimit': '27'}, {'value': '-8.5', 'groupId': 'OG001', 'lowerLimit': '-232', 'upperLimit': '650'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-20.0', 'groupId': 'OG000', 'lowerLimit': '-240', 'upperLimit': '208'}, {'value': '-51.0', 'groupId': 'OG001', 'lowerLimit': '-317', 'upperLimit': '80'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-21.0', 'groupId': 'OG000', 'lowerLimit': '-273', 'upperLimit': '393'}, {'value': '-53.0', 'groupId': 'OG001', 'lowerLimit': '-357', 'upperLimit': '60'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-15.0', 'groupId': 'OG000', 'lowerLimit': '-268', 'upperLimit': '269'}, {'value': '-49.5', 'groupId': 'OG001', 'lowerLimit': '-359', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 12, 16, 28 and 52', 'description': 'Change in central subfield thickness was measured by Spectral domain optical coherence tomography.', 'unitOfMeasure': 'µm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Absence of Intraretinal Fluid in the Central Subfield', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 4 weeks from baseline up to Week 52', 'description': 'Change in fluids was measured by Spectral domain optical coherence tomography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Absence of Subretinal Fluid in the Central Subfield', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 4 weeks from baseline up to Week 52', 'description': 'Change in fluids was measured by Spectral domain optical coherence tomography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 4 weeks from baseline up to Week 52', 'description': 'Change in fluids was measured by Spectral domain optical coherence tomography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Presence of Active Choroidal Neovascularization Leakage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Active CNV leakage at week 52 - Yes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Active CNV leakage at week 52 - No', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Active CNV leakage at week 52 - missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CNV location at week 52 - Subfoveal', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'CNV location at week 52 - Extrafoveal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'CNV location at week 52 - Not applicable', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'CNV location at week 52 - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CNV subtype at week 52 - Type 1 MNV', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'CNV subtype at week 52 - Mixed type 1 and type 2 MNV', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'CNV subtype at week 52 -Type 3 MNV', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'CNV subtype at week 52 - Not applicable', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'CNV subtype at week 52 - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 52', 'description': 'Presence of active choroidal neovascularization leakage was measured by Fluorescein angiography.\n\nCNV = choroidal neovascularization; MNV = macular neovascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'full analysis set'}, {'type': 'SECONDARY', 'title': 'Overview of TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Ocular AE(s) in the study eye', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Ocular AE(s) in the fellow eye', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Non-ocular AE(s)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'AE(s) related to injection procedure', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'AE(s) related to study drug', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'SAE(s)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Ocular SAE(s) in the study eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Non-ocular SAE(s)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Non-fatal SAE(s)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuation of study treatment due to any AE(s)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuation of study treatment due to non-serious AE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuation of study treatment due to any SAE(s)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'SECONDARY', 'title': 'Ocular TEAEs in the Study Eye by Primary System Organ Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'General disorders and administration site conditions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'SECONDARY', 'title': 'Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Conjunctival haemorrhage', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Visual acuity reduced', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Eye inflammation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Intraocular pressure increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Retinal oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Dry Eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neovascular age-related macular degeneration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Vitreous detachment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cataract', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Retinal exudates', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Vitreous floaters', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'SECONDARY', 'title': 'Non-ocular TEAEs - Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'SECONDARY', 'title': 'Ocular TEAEs in the Study Eye of Moderate or Severe Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'Any AE of moderate intensity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Cataract - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctival haemorrhage - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctival irritation - moderate intensity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctivitis allergic - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dry eye - moderate intensity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eye inflammation - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eye pain - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neovascular age-related macular degeneration - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Retinal vasculitis - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subretinal fluid - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visual acuity reduced - moderate intensity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vital dye staining cornea present - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vitreous opacities - moderate intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any AE of severe intensity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Endophthalmitis - severe intensity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye inflammation - severe intensity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Intraocular pressure increased - severe intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Retinal haemorrhage - severe intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Retinal neovascularization - severe intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visual acuity reduced - severe intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'classes': [{'title': 'On-treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Fatality data are reported from first dose of study treatment until approximately Week 52.', 'description': 'On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 30 days after last treatment, up to a maximum timeframe of approximately 52 weeks.\n\nPost-treatment death data are reported from day 31 after last treatment to end of study (Week 52).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'FG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'If both eyes were eligible as per the inclusion and exclusion criteria, the eye with the worse visual acuity should have been selected for study eye, unless the investigator deemed it more appropriate to select the eye with better visual acuity, based on medical reasons or local ethical requirements.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brolucizumab 6 mg Loading', 'description': '3 x 4-weekly initial injections followed by an injection every 12 weeks'}, {'id': 'BG001', 'title': 'Brolucizumab 6 mg Non-loading', 'description': 'One initial injection followed by treatment every 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '77.4', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '77.5', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-30', 'size': 1247759, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-19T10:00', 'hasProtocol': True}, {'date': '2024-03-25', 'size': 493298, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-19T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open-label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two arm, multicenter'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2020-12-03', 'resultsFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-12-19', 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'timeFrame': 'Baseline, Week 40 to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.'}], 'secondaryOutcomes': [{'measure': 'Treatment Intervals Before and During the Study', 'timeFrame': '-24 Weeks, Baseline, Week 52', 'description': 'Treatment interval distribution.\n\nTreatment interval during the study, within 24 weeks prior to baseline and interval between the last 2 injections in the study. In the loading arm, data from the loading period was excluded.'}, {'measure': 'Number of Patients With Prolonged Interval', 'timeFrame': 'Baseline, Week 52', 'description': 'Treatment interval distribution.\n\nProlongation was calculated by comparing the mean treatment interval in last 24 weeks prior to first brolucizumab injection (a) with the mean of the average treatment interval during the study (loading phase excluded in the loading arm) and (b) with the last treatment interval during the study. Patients with only 1 injection during the treatment period were calculated as non-responders (no prolon-gation).'}, {'measure': 'Proportion of Patients Who Maintained on q12w Regimen.', 'timeFrame': 'Up to week 52', 'description': 'Treatment interval distribution up to Week 52.\n\nProportion of patients maintained on q12w treatment frequency in the two brolucizumab groups up to week 52. Patients who discontinued treatment before week 52 were rated as non-responders, i.e., as patients who did not maintain the q12w regimen. In the loading arm, the loading period up to week 12 was not considered in the analysis.'}, {'measure': 'Distribution of Patients at Every 8 Weeks / Every 12 Weeks Intervals - Frequency of Switches in Treatment Intervals Between Baseline and Week 52', 'timeFrame': 'Up to Week 52', 'description': 'Treatment interval distribution'}, {'measure': 'Mean Change in Best-corrected Visual Acuity', 'timeFrame': 'Baseline, Weeks 16 to 28, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.'}, {'measure': 'Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters', 'timeFrame': 'Baseline, up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.'}, {'measure': 'Number of Patients With Best-corrected Visual Acuity >= 69 Letters', 'timeFrame': 'Baseline, up to Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.'}, {'measure': 'LS Mean Change in Best-corrected Visual Acuity From Baseline at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better functioning.'}, {'measure': 'Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52', 'timeFrame': 'Baseline, Weeks 12, 16, 28 and 52', 'description': 'Change in central subfield thickness was measured by Spectral domain optical coherence tomography.'}, {'measure': 'Absence of Intraretinal Fluid in the Central Subfield', 'timeFrame': 'Every 4 weeks from baseline up to Week 52', 'description': 'Change in fluids was measured by Spectral domain optical coherence tomography.'}, {'measure': 'Absence of Subretinal Fluid in the Central Subfield', 'timeFrame': 'Every 4 weeks from baseline up to Week 52', 'description': 'Change in fluids was measured by Spectral domain optical coherence tomography.'}, {'measure': 'Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield', 'timeFrame': 'Every 4 weeks from baseline up to Week 52', 'description': 'Change in fluids was measured by Spectral domain optical coherence tomography.'}, {'measure': 'Presence of Active Choroidal Neovascularization Leakage', 'timeFrame': 'At Week 52', 'description': 'Presence of active choroidal neovascularization leakage was measured by Fluorescein angiography.\n\nCNV = choroidal neovascularization; MNV = macular neovascularization'}, {'measure': 'Overview of TEAEs', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.'}, {'measure': 'Ocular TEAEs in the Study Eye by Primary System Organ Class', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.'}, {'measure': 'Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group)', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.'}, {'measure': 'Non-ocular TEAEs - Total', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.'}, {'measure': 'Ocular TEAEs in the Study Eye of Moderate or Severe Intensity', 'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 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 subject or clinical investigation subject after providing written informed consent for participation in the study.\n\nTreatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neovascular age-related macular degeneration', 'anti-VEGF', 'choroidal neovascularization', 'brolucizumab', 'loading vs. non-loading', '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', 'Retinal Degeneration', 'Retinal Diseases', 'Eye Diseases'], 'conditions': ['Age-related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '35188581', 'type': 'DERIVED', 'citation': 'Holz FG, Schmitz-Valckenberg S, Wolf A, Agostini H, Lorenz K, Pielen A, Feltgen N, Guthoff R, Quiering C, Clemens A, Jaeger K. A randomized, open-label, multicenter study of switching to brolucizumab with or without a loading dose for patients with suboptimal anatomically controlled neovascular age-related macular degeneration-the FALCON study. Graefes Arch Clin Exp Ophthalmol. 2022 Aug;260(8):2695-2702. doi: 10.1007/s00417-022-05591-z. Epub 2022 Feb 21.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2506', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of two different brolucizumab 6 mg dosing regimens in patients with visual impairment due to age-related macular degeneration (AMD) who have previously received anti-VEGF (vascular endothelial growth factor) treatment.', 'detailedDescription': 'This study was a 52-week randomized, open-label, multi-center, two-arm study for pretreated patients with suboptimal anatomically controlled nAMD. Patients who consented were screened to evaluate eligibility. Eligible patients were randomized in a 1:1 ratio to one of the two treatment arms:\n\n* Brolucizumab 6 mg "loading arm": 1 loading injection every 4 weeks for 3 consecutive injections (baseline, weeks 4 and 8) followed by an injection every 12 weeks.\n* Brolucizumab 6 mg "non-loading arm": one initial injection followed by an injection every 12 weeks\n\nThere were three periods in this study:\n\n* Screening period: from day -14 to baseline\n* Open-label treatment period: from baseline (day 1) to week 48\n* Post-treatment follow-up period: from week 48 to week 52\n\nIn both study arms, treatment intervals after the initiation phase were either 8 weeks or 12 weeks depending on disease activity status. More frequent injections, i.e., treatment intervals of \\< 8 weeks were not allowed after the initiation phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients ≥ 50 years of age at screening\n* Active choroidal neovascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (intraretinal fluid (IRF) and/or subretinal fluid (SRF) and/or sub-retinal pigment epithelium (sub-RPE) fluid that affects the central subfield, as seen by spectral domain optical coherence tomography (SD-OCT)) at screening, as confirmed by central reading center (study eye). If active CNV according to the above explained activity criteria is not detectable in screening image data (no IRF and no SRF), presence of residual and/or recurrent fluid (IRF and / or SRF) within the last 6 months before baseline visit is also considered eligible. In this case, historical images must be submitted for analysis by the central reading center.\n* Pretreatment with any anti-VEGF drug for a maximum of five years (60 months). Patients should have shown functional and/or anatomical treatment response to the pretreatment(s), prior to participating in this study.\n* The treatment initiation phase with the current anti-VEGF must have been completed for at least 6 months with continuous treatment in a ≥ q4w to ≤ q12w injection interval (±2-day window, i.e., 26 to 86 days inclusive) before the baseline visit. At least 4 weeks (minimum 26 days) must have passed between the last anti-VEGF pretreatment and baseline.\n* Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)\n\nExclusion Criteria:\n\n* Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)\n* Uncontrolled glaucoma defined as intraocular pressure (IOP) \\> 25 mmHg on medication, or according to investigator's judgement, at screening or baseline (study eye)\n* Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \\<20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)\n* Ocular treatments: treatment with anti-VEGF drugs for \\> 5 years in the study eye, pretreatment with brolucizumab at any time in the study eye, previous treatment with investigational drugs in the last 6 months, intraocular or periocular steroids at any time, macular laser photocoagulation or photodynamic therapy at any time, peripheral laser photocoagulation within 3 months prior to baseline, intraocular surgery within 3 months prior to baseline, vitreoretinal surgery at any time, aphakia with the absence of posterior capsule (study eye)\n* Stroke or myocardial infarction during the 6 month period prior to baseline\n* Systemic anti-VEGF therapy during the 3-month period prior to baseline"}, 'identificationModule': {'nctId': 'NCT04679935', 'acronym': 'FALCON', 'briefTitle': 'Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'CRTH258ADE01'}, 'secondaryIdInfos': [{'id': '2019-004767-53', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brolucizumab 6 mg non-loading', 'description': 'One initial injection followed by treatment every 12 weeks.', 'interventionNames': ['Biological: Brolucizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Brolucizumab 6 mg loading', 'description': '3 x 4-weekly injections followed by treatment every 12 weeks.', 'interventionNames': ['Biological: Brolucizumab']}], 'interventions': [{'name': 'Brolucizumab', 'type': 'BIOLOGICAL', 'otherNames': ['RTH258, Beovu'], 'description': 'Intravitreal injection', 'armGroupLabels': ['Brolucizumab 6 mg loading', 'Brolucizumab 6 mg non-loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Novartis 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'http://www.clinicalstudydatarequest.com/', '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. This trial data availability is according to the criteria and process described on ww.clinicalstudydatarequest.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}