Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-26 @ 2:37 AM
Study NCT ID:
NCT00964795
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2009-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '9148475385', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron'}, 'certainAgreement': {'otherDetails': 'The investigator (PI) may publish results provided a copy of oral/ written publication is received by sponsor at least 45 days in advance for review \\& comment. If the parties disagree, PI agrees to meet with sponsor prior to submission to resolve any disagreement. Sponsor reserves the right to remove confidential information from such submission. It is also agreed that publication of results shall be made only as part of a publication of the results obtained by all sites performing the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.', 'otherNumAtRisk': 323, 'otherNumAffected': 102, 'seriousNumAtRisk': 323, 'seriousNumAffected': 105}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Age-Related Macular Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 30}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 39}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cataract', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Conjunctival Haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 30}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Posterior Capsule Opacification', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal Detachment', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal Haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 34}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhagic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bundle Branch Block Right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendix Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal Angiodysplasia Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hiatus Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Large Intestine Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Device Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Biliary Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Escherichia Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis Norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pericolic Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia Respiratory Syncytial Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary Artery Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal Anastomotic Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatic Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Splenic Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wrist Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoporotic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Breast Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic Myelomonocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intraductal Proliferative Breast Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Invasive Ductal Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laryngeal Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophageal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Squamous Cell Carcinoma Of Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Embolic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Facial Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hemiplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertensive Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intracranial Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus Ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Obstructive Uropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal Failure Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ureteric Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Uterine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laryngospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Perivascular Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Medical Device Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angle Closure Glaucoma', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cataract', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Glaucoma', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal Haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal Oedema', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Visual Acuity Reduced', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Device Dislocation', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Endophthalmitis', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Corneal Abrasion', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intraocular Pressure Increased', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.'}], 'classes': [{'title': 'Number of participants with any TEAE', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}]}]}, {'title': 'Any ocular TEAE', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}]}]}, {'title': 'Any ocular TEAE: Study eye', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'Any ocular TEAE: Fellow eye', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}]}]}, {'title': 'Any non-ocular TEAE', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation of study due to AE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Any Death due to TEAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (day 1) through end of treatment (Week 180)', 'description': 'The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).\n\nTreatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BCVA Letter Score (mLOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '12.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 116', 'description': 'The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.\n\n(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).', 'unitOfMeasure': 'letters correctly read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Treatment Duration (Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.'}], 'classes': [{'categories': [{'measurements': [{'value': '110.4', 'spread': '42.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through end of treatment (Week 180)', 'description': 'Treatment Duration = (last dose date - first dose date + 28)/7', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Study Duration (Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.'}], 'classes': [{'categories': [{'measurements': [{'value': '116.9', 'spread': '44.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through end of treatment (Week 180)', 'description': 'Study Duration = (last visit/ discontinuation date - first dose date + 28)/7', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'randomized', 'groupId': 'FG000', 'numSubjects': '323'}]}, {'type': 'Number of Participants Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Prior to amendment 4, 16 participants completed up to Week 120. No participants completed Week 180.', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Termination of Study by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'Unwilling to sign ICF for amendment 4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'After informed consent was obtained, the 323 participants who completed the parent study, VGFT-OD-0605 (NCT00509795), and met the protocol eligibility criteria, were enrolled at 71 clinical sites in the US \\& Canada. The first visit occurred concurrently with the last visit in the parent study. The last participant entered this study on 18-May-2011.', 'preAssignmentDetails': 'Intravitreal Aflibercept Injection \\[commercially known EYLEA® (aflibercept) Injection\\] was approved in the US for treatment of neovascular ("wet") age-related macular degeneration (AMD) as the study was ongoing. For collection of long-term safety and best corrected visual acuity data on EYLEA®, the study was extended in the US from 30 to 45 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '7.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants included all participants who were enrolled in the study. The data were used to analyze the safety and efficacy parameters to characterize the long-term effect of Intravitreal Aflibercept Injection treatment. The average study duration for all enrolled participants was 116.9 weeks.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2009-08-20', 'resultsFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-10', 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Summary of Treatment Duration (Weeks)', 'timeFrame': 'Baseline through end of treatment (Week 180)', 'description': 'Treatment Duration = (last dose date - first dose date + 28)/7'}, {'measure': 'Summary of Study Duration (Weeks)', 'timeFrame': 'Baseline through end of treatment (Week 180)', 'description': 'Study Duration = (last visit/ discontinuation date - first dose date + 28)/7'}], 'primaryOutcomes': [{'measure': 'Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD', 'timeFrame': 'Baseline (day 1) through end of treatment (Week 180)', 'description': 'The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).\n\nTreatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs'}], 'secondaryOutcomes': [{'measure': 'Change in BCVA Letter Score (mLOCF)', 'timeFrame': 'Baseline through Week 116', 'description': 'The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.\n\n(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eyes', 'Neovascular', 'Macular Degeneration', 'Retina', 'AMD', 'VEGF Trap-Eye', 'Best Corrected Visual Acuity'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.', 'detailedDescription': 'The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.\n\nParticipants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participation in Study VGFT-OD-0605 through week 96.\n* In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.\n\nExclusion Criteria:\n\n* Presence of any condition that would jeopardize the patient's participation in this study.\n* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study."}, 'identificationModule': {'nctId': 'NCT00964795', 'briefTitle': 'Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'VGFT-OD-0910'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label Intravitreal Aflibercept Injection', 'description': 'Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.', 'interventionNames': ['Drug: Intravitreal Aflibercept Injection 2mg']}], 'interventions': [{'name': 'Intravitreal Aflibercept Injection 2mg', 'type': 'DRUG', 'otherNames': ['IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye'], 'armGroupLabels': ['Open-label Intravitreal Aflibercept Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham (2 Locations)', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix (2 Locations)', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson (2 Locations)', 'state': 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