Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01304693
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2011-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Georges Weissgerber, Executive Director, Novartis Pharma AG', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study (2 years, 5 months). An AE was considered to be any untoward medical occurrence in a patient exposed to study drug. The AE did not have to have had a causal relationship with the study drug.', 'description': 'This analysis population includes all patients exposed to the study drug, as treated. It should be noted that 6 patients were misdosed: 1 randomized to ESBA1008 B received ESBA1008 A; 1 randomized to ESBA1008 C received ESBA1008 B; and 4 randomized to ESBA1008 B received ESBA1008 D.', 'eventGroups': [{'id': 'EG000', 'title': 'ESBA1008 Dose A', 'description': 'Single intravitreal injection with 6-month follow-up', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ESBA1008 Dose B', 'description': 'Single intravitreal injection with 6-month follow-up', 'otherNumAtRisk': 31, 'otherNumAffected': 10, 'seriousNumAtRisk': 31, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'ESBA1008 Dose C', 'description': 'Single intravitreal injection with 6-month follow-up', 'otherNumAtRisk': 47, 'otherNumAffected': 17, 'seriousNumAtRisk': 47, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'ESBA1008 Dose D', 'description': 'Single intravitreal injection with 6-month follow-up', 'otherNumAtRisk': 44, 'otherNumAffected': 16, 'seriousNumAtRisk': 44, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Lucentis', 'description': 'Single intravitreal injection with 6-month follow-up', 'otherNumAtRisk': 61, 'otherNumAffected': 13, 'seriousNumAtRisk': 61, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharnygitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post-procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aortic bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ESBA1008 Dose A', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG001', 'title': 'ESBA1008 Dose B', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG002', 'title': 'ESBA1008 Dose C', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG003', 'title': 'ESBA1008 Dose D', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG004', 'title': 'Lucentis', 'description': 'Single intravitreal injection with 6-month follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '-142.3', 'spread': '78.8', 'groupId': 'OG000'}, {'value': '-181.6', 'spread': '107.2', 'groupId': 'OG001'}, {'value': '-175.6', 'spread': '138.9', 'groupId': 'OG002'}, {'value': '-174.9', 'spread': '101.3', 'groupId': 'OG003'}, {'value': '-159.4', 'spread': '110.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1', 'description': 'CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT). Efficacy data from visits occurring after standard of care (SoC) were censored and replaced based on LOCF,i.e. by the data observed at the time of the SoC decision.'}, {'type': 'SECONDARY', 'title': 'Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ESBA1008 Dose A', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG001', 'title': 'ESBA1008 Dose B', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG002', 'title': 'ESBA1008 Dose C', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG003', 'title': 'ESBA1008 Dose D', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'OG004', 'title': 'Lucentis', 'description': 'Single intravitreal injection with 6-month follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '60'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '120'}, {'value': '67.5', 'groupId': 'OG002', 'lowerLimit': '37.5', 'upperLimit': '120'}, {'value': '75', 'groupId': 'OG003', 'lowerLimit': '37.5', 'upperLimit': '150'}, {'value': '45', 'groupId': 'OG004', 'lowerLimit': '25', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time to event, up to Month 6', 'description': 'Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: All patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ESBA1008 Dose A', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'FG001', 'title': 'ESBA1008 Dose B', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'FG002', 'title': 'ESBA1008 Dose C', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'FG003', 'title': 'ESBA1008 Dose D', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'FG004', 'title': 'Lucentis', 'description': 'Single intravitreal injection with 6-month follow-up'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Decision Unrelated to an Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 51 investigational centers located in the United States, Europe, Israel, and Australia.', 'preAssignmentDetails': 'Of the 376 enrolled, 182 were exited as screen failures prior to exposure to randomization and exposure to the study drug. This reporting group includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT) (194).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '194', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'ESBA1008 Dose A', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'BG001', 'title': 'ESBA1008 Dose B', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'BG002', 'title': 'ESBA1008 Dose C', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'BG003', 'title': 'ESBA1008 Dose D', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'BG004', 'title': 'Lucentis', 'description': 'Single intravitreal injection with 6-month follow-up'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.9', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '78.5', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '75.2', 'spread': '7.7', 'groupId': 'BG002'}, {'value': '74.5', 'spread': '9.8', 'groupId': 'BG003'}, {'value': '77.8', 'spread': '8.1', 'groupId': 'BG004'}, {'value': '76.5', 'spread': '8.4', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (Intent-to-Treat).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '106', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '88', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2011-02-24', 'resultsFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-07', 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)', 'timeFrame': 'Baseline, Month 1', 'description': 'CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.'}], 'secondaryOutcomes': [{'measure': 'Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria', 'timeFrame': 'Time to event, up to Month 6', 'description': 'Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AMD', 'Wet AMD', 'Exudative', 'CNV'], 'conditions': ['Exudative Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).', 'detailedDescription': 'This study was conducted in two parts. In Part 1, patients were initially randomized (5:2) to receive either ESBA1008 at the lowest dose (Dose A) or LUCENTIS. After Safety Committee review, a second cohort was enrolled and randomized (5:2) to the next higher dose of ESBA1008 (Dose B). Safety review and enrollment of patients into the third cohort (Dose C) and fourth cohort (Dose D) was conducted in the same manner. Part 2, the expansion period, consisted of 2 arms. In the first arm patients were randomized to receive ESBA1008 Dose C or LUCENTIS (43:44) . In the second arm, patients were randomized to ESBA1008 Doses A:B:D:Lucentis (5:30:35:9). All enrolled patients (Part 1 and Part 2) were evaluated for safety and efficacy across 13 study visits, including Screening, Randomization, and 11 post- treatment follow-up visits (Day 1 through Month 6).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent.\n* Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.\n* New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.\n* Evidence of subretinal fluid or retinal cystic changes with a CSFT of \\> 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.\n* Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Previously administered therapy, approved or investigational, for wet AMD in the study eye.\n* Any current or history of macular or retinal disease in the stuy eye other than wet AMD.\n* Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.\n* Uncontrolled or advanced glaucoma in the study eye.\n* Use of systemic or topical ocular corticosteroids.\n* History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.\n* Abnormal or unsuitable laboratory results at Screening visit.\n* Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01304693', 'briefTitle': 'ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'C-10-083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESBA1008', 'description': 'ESBA1008 solution, single intravitreal injection', 'interventionNames': ['Biological: ESBA1008 solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LUCENTIS', 'description': 'Ranibizumab 0.5 mg, single intravitreal injection', 'interventionNames': ['Biological: Ranibizumab 0.5 mg']}], 'interventions': [{'name': 'ESBA1008 solution', 'type': 'BIOLOGICAL', 'description': 'Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)', 'armGroupLabels': ['ESBA1008']}, {'name': 'Ranibizumab 0.5 mg', 'type': 'BIOLOGICAL', 'otherNames': ['LUCENTIS®'], 'description': 'Administered as a single intravitreal injection', 'armGroupLabels': ['LUCENTIS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Georges Weissgerber, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}