Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-27 @ 7:20 PM
Study NCT ID:
NCT04049266
Status:
TERMINATED
Last Update Posted:
2024-07-18
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057135', 'term': 'Wet Macular Degeneration'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinOps@kodiak.com', 'phone': '1 (650) 281-0850', 'title': 'Pablo Velazquez-Martin, MD', 'organization': 'Kodiak Sciences Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) reported through Week 52 or Early Termination (ET) if occurred before Week 52.', 'description': 'Safety results for the KSI-301 5mg arm are presented together as patients treated with Q12W dosing received 6 total doses in Year 1 and the patients treated with Q20W dosing received 5 total doses in Year 1. Therefore, presenting all treatment intervals together provides a more robust dataset to evaluate the safety profile of KSI-301.', 'eventGroups': [{'id': 'EG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.', 'otherNumAtRisk': 277, 'deathsNumAtRisk': 277, 'otherNumAffected': 82, 'seriousNumAtRisk': 277, 'deathsNumAffected': 4, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52', 'otherNumAtRisk': 280, 'deathsNumAtRisk': 280, 'otherNumAffected': 84, 'seriousNumAtRisk': 280, 'deathsNumAffected': 8, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Neovascular age-related macular degeneration - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Retinal haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Conjunctival haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Endophthalmitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Retinal haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Neovascular age-related macular degeneration - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Rhegmatogenous retinal detachment - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Ilium fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Intestinal dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Perforated ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Transient aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Benign gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Colon cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Prostatic varices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 277, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '7', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.9999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.03', 'paramValue': '-6.0', 'ciLowerLimit': '-8', 'ciUpperLimit': '-4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'MMRM model with treatment, visit, treatment by visit interaction, categories for baseline BCVA, BCVA-low luminance VA baseline, geographical location.', 'nonInferiorityComment': 'The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4 ETDRS letters, i.e. the non-inferiority margin (NI) is 4 letters.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 1', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set defined as all randomized subjects who received at least one treatment injection in Year 1. Subjects will be analyzed according to their randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'KSI-301 5 mg', 'description': 'Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol.\n\nDrug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.\n\nKSI-301: Intravitreal Injection\n\nSham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.'}], 'classes': [{'categories': [{'title': 'Number of participants on the KSI-301 Q12W', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}, {'title': 'Number of participants on the KSI-301 Q16W', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Number of participants on the KSI-301 Q20W', 'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Year 1', 'description': 'Percentage of subjects on KSI-301 arm achieving a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval based on individualized treatment response', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Available Data at the Planned Durability Assessment at Year 1'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KSI-301 5 mg', 'description': 'Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol.\n\nDrug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.\n\nKSI-301: Intravitreal Injection\n\nSham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg', 'description': 'Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.\n\nDrug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.\n\nAflibercept: Intravitreal Injection\n\nSham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.'}], 'classes': [{'title': 'Gain >=5 ETDRS Letters at Year 1', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}, {'title': 'Gain >=10 ETDRS Letters at Year 1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Gain >=15 ETDRS Letters at Year 1', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Year 1', 'description': 'Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received at least one treatment injection in Year 1 with available data at Year 1 for analysis. Number of participants in each Row Title is not mutually exclusive as number of participants who gained \\>=15 ETDRS letters includes participants who gained \\>=10 ETDRS letters and participants who gained \\>=5 ETDRS letters.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Year 1', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/40 was defined as ≥69 ETDRS letters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received at least one treatment injection in Year 1 with available data at Year 1 for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Year 1', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/200 or Worse was defined as BCVA ≤ 38 ETDRS Letters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received at least one treatment injection in Year 1 with available data at Year 1 for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.'}, {'id': 'OG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '-96.1', 'spread': '123.39', 'groupId': 'OG000'}, {'value': '-134.1', 'spread': '111.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Year 1', 'description': 'Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center.', 'unitOfMeasure': 'Microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set defined as all randomized subjects who received at least one treatment injection in Year 1. Subjects will be analyzed according to their randomized treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.'}, {'id': 'FG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant did not receive any treatment.', 'groupId': 'FG000', 'numSubjects': '277'}, {'comment': 'One participant did not receive any treatment.', 'groupId': 'FG001', 'numSubjects': '280'}]}, {'type': 'COMPLETED', 'comment': 'Completed is defined as participants who completed treatment through Year 1.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral at 72 medical centers between September 2019 and November 2020. The first participant was enrolled on 08 October 2019 and the last on 24 November 2020.', 'preAssignmentDetails': 'Of 785 participants screened, 559 were randomized to treatment. Two randomized subjects (one subject in KSI-301 arm and one subject in aflibercept arm) never received treatment, so do not have reason for not completing treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KSI-301 5 mg Q12W-Q20W', 'description': 'Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52.'}, {'id': 'BG001', 'title': 'Aflibercept 2 mg Q8W', 'description': 'Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '516', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.6', 'spread': '7.35', 'groupId': 'BG000'}, {'value': '76.2', 'spread': '8.27', 'groupId': 'BG001'}, {'value': '76.4', 'spread': '7.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BCVA in the Study Eye, Letters', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '12.34', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '12.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Letters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-02', 'size': 1936165, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-04T15:21', 'hasProtocol': True}, {'date': '2022-02-03', 'size': 1878514, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-04T15:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A masked evaluating investigator will be responsible for subject care except the injections and the safety assessment following the injections. An unmasked treating investigator will perform the injections and assess patient safety following the injections.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 559}}, 'statusModule': {'whyStopped': 'Primary Endpoint Not Met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2019-08-06', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1', 'timeFrame': 'Year 1', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval', 'timeFrame': 'Year 1', 'description': 'Percentage of subjects on KSI-301 arm achieving a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval based on individualized treatment response'}, {'measure': 'Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1', 'timeFrame': 'Year 1', 'description': 'Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart'}, {'measure': 'Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1', 'timeFrame': 'Year 1', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/40 was defined as ≥69 ETDRS letters'}, {'measure': 'Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1', 'timeFrame': 'Year 1', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/200 or Worse was defined as BCVA ≤ 38 ETDRS Letters.'}, {'measure': 'Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1', 'timeFrame': 'Year 1', 'description': 'Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AMD', 'Wet AMD', 'choroidal neovascularization secondary to age-related macular degeneration', 'KSI-301', 'Aflibercept', 'Vascular endothelial growth factor', 'VEGF', 'Anti-VEGF', 'Antibody biopolymer conjugate', 'Macular Degeneration', 'Wet Macular Degeneration', 'Retinal Degeneration', 'Retinal Diseases', 'Eye Diseases', 'Vision Disorders', 'Vision, low', 'Kodiak'], 'conditions': ['Wet Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).', 'detailedDescription': 'This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent prior to participation in the study.\n* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.\n* BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.\n* Other protocol-specified inclusion criteria may apply\n\nExclusion Criteria:\n\n* CNV secondary to other causes in the Study Eye.\n* Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.\n* Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.\n* Active ocular or periocular infection or inflammation.\n* Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.\n* Uncontrolled glaucoma in the Study Eye.\n* Women who are pregnant or lactating or intending to become pregnant during the study.\n* Stroke or myocardial infarction in the 6-month period prior to Day 1.\n* Uncontrolled blood pressure defined as a systolic value \\> 180 mmHg or diastolic value ≥100 mmHg while at rest.\n* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04049266', 'acronym': 'DAZZLE', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kodiak Sciences Inc'}, 'officialTitle': 'A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.', 'orgStudyIdInfo': {'id': 'KSI-CL-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KSI-301 5 mg', 'description': 'Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol.\n\nDrug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.', 'interventionNames': ['Drug: KSI-301', 'Other: Sham Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept 2 mg', 'description': 'Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.\n\nDrug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.', 'interventionNames': ['Drug: Aflibercept', 'Other: Sham Procedure']}], 'interventions': [{'name': 'KSI-301', 'type': 'DRUG', 'description': 'Intravitreal Injection', 'armGroupLabels': ['KSI-301 5 mg']}, {'name': 'Aflibercept', 'type': 'DRUG', 'otherNames': ['Eylea'], 'description': 'Intravitreal Injection', 'armGroupLabels': ['Aflibercept 2 mg']}, {'name': 'Sham Procedure', 'type': 'OTHER', 'description': 'The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.', 'armGroupLabels': ['Aflibercept 2 mg', 'KSI-301 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Retina Associates', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Associates', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '93720', 'city': 'Fresno', 'state': 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'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Retinal Consultants PC', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Vitreoretinal Surgery PA', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Springfield Clinic LLP', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07017', 'city': 'Bloomfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Retina Center of New Jersey', 'geoPoint': {'lat': 40.80677, 'lon': -74.18542}}, {'zip': '07605', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NJ Retina', 'geoPoint': {'lat': 40.8976, 'lon': 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'facility': 'Retina Consultants of Texas (Katy)', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Retina Associates (Round Rock)', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas (Woodlands)', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '76087', 'city': 'Willow Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Strategic Clinical Research Group, LLC', 'geoPoint': {'lat': 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