Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-01 @ 10:52 AM
Study NCT ID:
NCT03861234
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057135', 'term': 'Wet Macular Degeneration'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.', 'description': 'Treated Set (TS): All patients who were treated with at least one dose of BI 836880.', 'eventGroups': [{'id': 'EG000', 'title': '0.06 mg BI 836880 - SRD Part', 'description': '0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '0.18 mg BI 836880 - SRD Part', 'description': '0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.5 mg BI 836880 - SRD Part', 'description': '0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1 mg BI 836880 - SRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '2 mg BI 836880 - SRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anterior chamber cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lenticular opacities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Meibomian gland dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Subretinal fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreal cells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous opacities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chorioretinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cataract operation 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'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Neovascular age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Retinal occlusive vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 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[{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.06 mg BI 836880 - SRD Part', 'description': '0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '0.18 mg BI 836880 - SRD Part', 'description': '0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG002', 'title': '0.5 mg BI 836880 - SRD Part', 'description': '0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT 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{'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.', 'description': 'Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set: All patients who were treated with at least on dose of BI 836880. SRD-part.'}, {'type': 'SECONDARY', 'title': 'SRD-part: Number of Participants With Drug Related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.06 mg BI 836880 - SRD Part', 'description': '0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '0.18 mg BI 836880 - SRD Part', 'description': '0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG002', 'title': '0.5 mg BI 836880 - SRD Part', 'description': '0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG003', 'title': '1 mg BI 836880 - SRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG004', 'title': '2 mg BI 836880 - SRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.', 'description': 'Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who were treated with at least one dose of BI 836680. SRD-part.'}, {'type': 'SECONDARY', 'title': 'SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.06 mg BI 836880 - SRD Part', 'description': '0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '0.18 mg BI 836880 - SRD Part', 'description': '0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG002', 'title': '0.5 mg BI 836880 - SRD Part', 'description': '0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG003', 'title': '1 mg BI 836880 - SRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG004', 'title': '2 mg BI 836880 - SRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.', 'description': 'Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who were treated with at least one dose of BI 836880. SRD-part.'}, {'type': 'PRIMARY', 'title': 'MRD-part: Number of Participants With Drug Related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'OG002', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.', 'description': 'Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set: All patients who were treated with at least on dose of BI 836880. MRD-part.'}, {'type': 'SECONDARY', 'title': 'MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'OG002', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.7554', 'spread': '18.9936', 'groupId': 'OG000'}, {'value': '-26.5552', 'spread': '12.1400', 'groupId': 'OG001'}, {'value': '-0.1372', 'spread': '20.1706', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at week 12.', 'description': 'Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All patients who were treated with at least one dose of BI 836880 and have baseline and on-treatment CSFT measurements for the study eye in the time interval from drug administration to Week 12. MRD part.'}, {'type': 'SECONDARY', 'title': 'MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'OG002', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '22.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at Week 12.', 'description': "Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts.\n\nBCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment.", 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All patients who were treated with at least one dose of BI 836880 and have baseline and on-treatment CSFT measurements for the study eye in the time interval from drug administration to Week 12. MRD part.'}, {'type': 'SECONDARY', 'title': 'MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'OG002', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '16.1'}, {'value': 'NA', 'comment': 'Median and confidence interval could not be calculated, as there was no event ("recurrence").', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper confidence interval could not be calculated, as all patients either censored or had events before the probability of recurrence reached to 50%.', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From last drug administration at Week 8 until End of Trial, up to 16 weeks.', 'description': "Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator:\n\n* Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR\n* Decrease in BCVA of \\>5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR\n* Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored.", 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who were treated with at least one dose of BI 836880. MRD-part.'}, {'type': 'SECONDARY', 'title': 'MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'OG001', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'OG002', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.', 'description': 'Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who were treated with at least one dose of BI 836880. MRD-part.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.06 mg BI 836880 - SRD Part', 'description': '0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'FG001', 'title': '0.18 mg BI 836880 - SRD Part', 'description': '0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'FG002', 'title': '0.5 mg BI 836880 - SRD Part', 'description': '0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'FG003', 'title': '1 mg BI 836880 - SRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'FG004', 'title': '2 mg BI 836880 - SRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'FG005', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'FG006', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'FG007', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '13'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'comment': 'Completed trial mediation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Study medication discontinued due to safety notification', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'As per sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'IMP on hold as per sponsor instructions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A non-randomised, uncontrolled, open label trial consisting of a single rising dose (SRD) part followed by a multiple rising dose (MRD) part. The SRD part and MRD cohort 1 included patients with treatment-resistant wet age-related macular degeneration (wAMD). Patients with treatment-naïve wAMD were included in MRD cohort 2 and patients within 3 years of initial wAMD were included in MRD cohort 3.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '0.06 mg BI 836880 - SRD Part', 'description': '0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'BG001', 'title': '0.18 mg BI 836880 - SRD Part', 'description': '0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'BG002', 'title': '0.5 mg BI 836880 - SRD Part', 'description': '0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'BG003', 'title': '1 mg BI 836880 - SRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'BG004', 'title': '2 mg BI 836880 - SRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'BG005', 'title': '1 mg BI 836880 - Cohort 1 MRD Part', 'description': '1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).'}, {'id': 'BG006', 'title': '2 mg BI 836680 - Cohort 2 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.'}, {'id': 'BG007', 'title': '2 mg BI 836680 - Cohort 3 MRD Part', 'description': '2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '76.7', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '75.3', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '75.7', 'spread': '1.5', 'groupId': 'BG003'}, {'value': '70.7', 'spread': '1.2', 'groupId': 'BG004'}, {'value': '77.0', 'spread': '4.8', 'groupId': 'BG005'}, {'value': '69.3', 'spread': '13.0', 'groupId': 'BG006'}, {'value': '77.0', 'spread': '6.3', 'groupId': 'BG007'}, {'value': '75.9', 'spread': '6.4', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): All patients who were treated with at least one dose of BI 836880.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-28', 'size': 996016, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-22T04:14', 'hasProtocol': True}, {'date': '2024-02-02', 'size': 342370, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-22T04:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2019-02-26', 'resultsFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-29', 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)', 'timeFrame': 'From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.', 'description': 'Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).'}, {'measure': 'MRD-part: Number of Participants With Drug Related Adverse Events (AEs)', 'timeFrame': 'From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.', 'description': 'Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs)'}], 'secondaryOutcomes': [{'measure': 'SRD-part: Number of Participants With Drug Related Adverse Events (AEs)', 'timeFrame': 'From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.', 'description': 'Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs).'}, {'measure': 'SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye', 'timeFrame': 'From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.', 'description': 'Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye.'}, {'measure': 'MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12', 'timeFrame': 'At baseline and at week 12.', 'description': 'Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12.'}, {'measure': 'MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12', 'timeFrame': 'At baseline and at Week 12.', 'description': "Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts.\n\nBCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment."}, {'measure': 'MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit', 'timeFrame': 'From last drug administration at Week 8 until End of Trial, up to 16 weeks.', 'description': "Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator:\n\n* Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR\n* Decrease in BCVA of \\>5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR\n* Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored."}, {'measure': 'MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye', 'timeFrame': 'From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.', 'description': 'Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wet Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a study in people with an eye disease called wet age-related macular degeneration (wAMD). The purpose of the study is to find out how well different doses of a medicine called BI 836880 are tolerated.\n\nPeople can participate if they are at least 55 years old and if they have new blood vessels in their eyes despite treatment (anti-VEGF therapies). The study has 2 parts. In the first part, people get only 1 dose of BI 836880. This part takes 6 weeks. In the second part, people get 3 times the same dose of BI 836880. This part takes 6 months. BI 836880 is injected into the eye. During the entire study doctors regularly check the health of the participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSRD part and MRD cohort 1 (treatment-resistant patients with wAMD):\n\n* Men and women over the age of 55 with active Choroidal Neovascularisation (CNV) secondary to age-related macular degeneration (AMD) despite anti-Vascualr endothelial growth factor (VEGF) therapies (at least 3 prior injections with the last injection within 16 to 4 weeks before treatment). Active CNV secondary to AMD is to be defined either by recent fluorescein or optical coherence tomography (OCT) angiogram within 4 weeks prior to screening or fluorescein or OCT angiogram obtained prior to first anti VEGF-treatment to confirm the diagnosis and still active according to investigator judgement.\n* For MRD part only: Central subfield retinal thickness \\>300 microns in the study eye on Heidelberg Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT).\n* Presence of sub- and/or intraretinal fluid on SD-OCT in the study eye.\n* Any active CNV with subfoveal leakage in the study eye as determined by OCT\n* No subretinal hemorrhage involving the fovea in the study eye.\n* No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator, is able to prevent improvement in best corrected visual acuity (BCVA) and/or central subfield thickness (CSFT).\n* Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 75 and 24 letters inclusive (approximately 20/32 and 20/320 or 6/9.5 and 6/95) at screening.\n* Best-corrected VA in the non-study eye better than best-corrected VA in the study-eye. If both eyes are eligible and have identical VA the investigator may select the study eye.\n* Male or female patients. Women of childbearing potential (WOCBP) cannot be included. Men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\n* Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.\n* Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.\n\nMRD cohort 2 (treatment-naive patients with wAMD):\n\n* No subretinal hemorrhage involving the fovea in the study eye.\n* No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator, is able to prevent improvement in BCVA and/or CSFT.\n* Male or female patients. Women of childbearing potential (WOCBP) cannot be included. Men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\n* Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.\n* Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.\n* Men and women over the age of 55 with treatment-naïve CNV secondary to AMD.\n* Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or angiographic leakage.\n* Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 6/7.5 and 6/95) at screening.\n* Best-corrected ETDRS VA in the non-study eye 50 letters inclusive (approximately 20/100 or 6/30) or better at screening.\n* If both eyes are eligible at screening, the study eye is the eye with the worse bestcorrected VA.\n\nMRD cohort 3 (frequently treated patients):\n\n* No subretinal hemorrhage involving the fovea in the study eye.\n* No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator and with the endorsement of the Sponsor, is able to prevent improvement in BCVA.\n* Male or female patients. Women of childbearing potential (WOCBP)1 cannot be included.Men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\n* Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.\n* Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.\n* Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or angiographic leakage.\n* Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 6/7.5 and 6/95) at screening.\n* If both eyes are eligible at screening, the study eye is the eye with the worse bestcorrected VA.\n* Men and women over the age of 55 with diagnosed wAMD that:\n\n * require frequent wAMD SoC (28-56 days between the last 3 treatments)\n * have had ≥ 3 previous treatments with IVT SoC (ranibizumab, aflibercept, or bevacizumab) in the study eye\n * had the last SoC injection ≥ 4 weeks, but no more than 8 weeks, before the first administration of the study drug\n * have been on SoC treatment ≥ 6 months and are within 3 years from initial wAMD diagnosis in the study eye\n\nExclusion criteria:\n\n* Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (intraocular pressure (IOP)\\> 24 mmHg on more than 2 consecutive measurements prior to screening), clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinalvascular occlusion, symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa); history of high myopia \\> 8 diopters in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with SD-OCT.\n* Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract within 3 months prior to screening.\n* Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy permitted, more than 1 month prior to enrollment in the study eye.\n* Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol).\n* Medical history or condition: Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) \\> 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, concomitant use of warfarin or anticoagulation therapy (use of antiplatelet therapy such as aspirin is allowed), major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension.\n* Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.0-fold the upper limit of normal at screening. Patients with total bilirubin 2.5x upper limit of normal at screening.\n* Patient with impaired renal function defined as calculated glomerular filtration rate (GFR) \\< 30 mL/min.\n* Significant alcohol or drug abuse within past 2 years per investigator judgement.\n* Further exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT03861234', 'briefTitle': 'A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Pharmacodynamics of Single Rising Intravitreal and Multiple Rising Intravitreal Doses of BI 836880 in Patients With wAMD (Open Label, Non-randomized, Uncontrolled).', 'orgStudyIdInfo': {'id': '1336-0007'}, 'secondaryIdInfos': [{'id': '2017-001221-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.06 mg BI 836880 - SRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '0.18 mg BI 836880 - SRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '0.5 mg BI 836880 - SRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '1 mg BI 836880 - SRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '2 mg BI 836880 - SRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '1 mg BI 836880 - cohort 1 MRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '2 mg BI 836680 - cohort 2 MRD part', 'interventionNames': ['Drug: BI 836880']}, {'type': 'EXPERIMENTAL', 'label': '2 mg BI 836680 - cohort 3 MRD part', 'interventionNames': ['Drug: BI 836880']}], 'interventions': [{'name': 'BI 836880', 'type': 'DRUG', 'description': 'Solution for Intravitreal (IVT) injection', 'armGroupLabels': ['0.06 mg BI 836880 - SRD part', '0.18 mg BI 836880 - SRD part', '0.5 mg BI 836880 - SRD part', '1 mg BI 836880 - SRD part', '1 mg BI 836880 - cohort 1 MRD part', '2 mg BI 836680 - cohort 2 MRD part', '2 mg BI 836680 - cohort 3 MRD part', '2 mg BI 836880 - SRD part']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary of Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Verum Research, LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Erie Retina Research, LLC', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Research Institute of Texas', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '78750', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Clinical Research, LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - 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