Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT04522167
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@formycon.com', 'phone': '+49 89 864667 100', 'title': 'Public Register Contact', 'organization': 'Formycon AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs reported until the final end of study visit at week 56 are included.', 'description': 'Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar), Systemic AE', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.\n\nIn this column all systemic AEs by patient for the FYB203 group are given.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 56, 'seriousNumAtRisk': 215, 'deathsNumAffected': 4, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Eylea® (Aflibercept), Systemic AE', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.\n\nIn this column all systemic AEs by patient for the Eylea® group are given.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 46, 'seriousNumAtRisk': 218, 'deathsNumAffected': 1, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Study Eye', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.\n\nIn this column all ocular AEs by patient for the FYB203 group occurring in the study eye are given.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 44, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Eylea® (Aflibercept), Ocular AE, Study Eye', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.\n\nIn this column all ocular AEs by patient for the Eylea® group occurring in the study eye are given.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 49, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Fellow Eye', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.\n\nThe fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 19 patients choose to get treatment for the fellow eye (from 1 to 6 injections).\n\nIn this column all ocular AEs by patient for the FYB203 group occurring in the fellow eye are given.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 37, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Eylea® (Aflibercept), Ocular AE, Fellow Eye', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.\n\nThe fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 20 patients choose to get treatment for the fellow eye (from 1 to 6 injections).\n\nIn this column all ocular AEs by patient for the Eylea® group occurring in the fellow eye are given.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 32, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Neovascular age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 25, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Gallbladder empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Toxic shock syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 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connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Nerve root injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Corneal dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 23.0 Mixed'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90.4', 'paramValue': '1.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the confidence interval for difference in LSMeans is completely contained in the interval \\]-3.5 letters; 3.5 letters\\[, FBY203 and Eylea are considered equivalent.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8', 'description': 'Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare Functional Changes of the Retina by BCVA Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'to Week 24 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '9.51', 'groupId': 'OG001'}]}]}, {'title': 'to Week 56 (Visit 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '10.37', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '11.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Change of BCVA by ETDRS letters over the whole study from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS = Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'to Week 4 (Visit 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-163.9', 'spread': '142.17', 'groupId': 'OG000'}, {'value': '-168.4', 'spread': '126.36', 'groupId': 'OG001'}]}]}, {'title': 'to Week 24 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-165.9', 'spread': '174.98', 'groupId': 'OG000'}, {'value': '-172.4', 'spread': '153.00', 'groupId': 'OG001'}]}]}, {'title': 'to Week 56 (Visit 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-188.4', 'spread': '181.08', 'groupId': 'OG000'}, {'value': '-202.4', 'spread': '156.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Change from Baseline Visit (Visit 1) in foveal center point FCP retinal thickness to Week 4 (Visit 2), Week 24 (Visit 5) and Week 56 (Visit 9) - FAS', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS = Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'to Week 24 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'title': '≥ 15 letters (gain 15 or more)', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': '≥ 10 and < 15 letters (gain 10-14)', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': '≥ 5 and < 10 letters (gain 5-9)', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': '> -5 and < 5 letters (gain or loss up to 4)', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': '> -10 and ≤ -5 letters (loss 5-9)', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '> -15 and ≤ -10 letters (loss 10-14)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '≤ -15 letters (loss 15 or more)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'to Week 56 (Visit 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'title': '≥ 15 letters (gain 15 or more)', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': '≥ 10 and < 15 letters (gain 10-14)', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': '≥ 5 and < 10 letters (gain 5-9)', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': '> -5 and < 5 letters (gain or loss up to 4)', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': '> -10 and ≤ -5 letters (loss 5-9)', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '> -15 and ≤ -10 letters (loss 10-14)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '≤ -15 letters (loss 15 or more)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, until Week 56 (Week 9)', 'description': 'Proportion of patients who gain or lose ≥ 5, 10, or 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS = Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'Baseline (Visit 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Assessment / Response = Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Assessment / Response = No', 'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Assessment / Response = Yes', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Assessment / Response = No', 'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Week 56 (Visit 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Assessment / Response = Yes', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'title': 'Assessment / Response = No', 'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Percentage of patients with fluid-free macula at Baseline (Visit 1), Week 24 (Visit 5), Week 56 (Visit 9) - FAS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS = Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'Baseline (Visit 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.000', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '2.000', 'spread': '0.0000', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3a (48h after 3rd dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.166', 'spread': '30.5161', 'groupId': 'OG000'}, {'value': '120.112', 'spread': '28.9556', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline and Visit 3a (48 hours after the 3rd dose)', 'description': 'Systemic concentrations (close to maximum concentration \\[Cmax\\]) of free aflibercept in a subgroup at selected sites - PKS:\n\n\\- 48 hours after the 3rd dose (Visit 3a)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS = Plasma Concentration Analysis Set. Baseline values that were reported as \\<LLOQ were analyzed with a numeric value of 0.5\\*LLOQ.'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'to Week 24 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '11.06', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '10.97', 'groupId': 'OG001'}]}]}, {'title': 'to Week 56 (Visit 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '12.22', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '12.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Change from Baseline Visit (Visit 1) in vision-related functioning and well-being measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS. The NEI VFQ-25 includes 12 subscales (e.g., general vision, ocular pain, driving, peripheral vision) scored from 0 to 100, where higher scores indicate better functioning. Subscales are averaged to produce a composite score, excluding the general health subscale. Both subscale and composite scores range from 0 (worst) to 100 (best), representing the percentage of the highest possible score achieved.', 'unitOfMeasure': 'score points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS = Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'Week 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Negative', 'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Negative', 'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}, {'title': 'Week 56 (Visit 9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Negative', 'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Number of patients with anti-drug antibodies (ADAs) at Baseline (Visit 1), Week 24 (Visit 5) and Week 56 (Visit 9) - SAF', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF = Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'OG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'local AEs, study eye', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'local AEs, fellow eye', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'systemic AEs', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) - SAF', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF = Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'FG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'Only 1 eye was selected from each patient as the study eye. Patients with signs of nAMD in the fellow eye likely to require IVT anti-VEGF treatment during the study were excluded. Any necessary treatment for wAMD in the fellow eye was prohibited for the first eight weeks and could only occur with Eylea at least 14 days after study eye treatment, without classifying the fellow eye as a study eye.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FYB203 (Proposed Aflibercept Biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.\n\nFYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'BG001', 'title': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.\n\nEylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'spread': '7.72', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '7.70', 'groupId': 'BG001'}, {'value': '73.5', 'spread': '7.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, Categorical', 'categories': [{'title': 'Between 18 and 64 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Between 65 and 84 years', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}, {'title': '>= 85 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '425', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set (SAF)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-15', 'size': 2533594, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-07T13:03', 'hasProtocol': True}, {'date': '2023-03-29', 'size': 851153, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-07T13:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 434}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2020-08-11', 'resultsFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-31', 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.', 'timeFrame': 'Week 8', 'description': 'Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.'}], 'secondaryOutcomes': [{'measure': 'Evaluate and Compare Functional Changes of the Retina by BCVA Over Time', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Change of BCVA by ETDRS letters over the whole study from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS'}, {'measure': 'Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Change from Baseline Visit (Visit 1) in foveal center point FCP retinal thickness to Week 4 (Visit 2), Week 24 (Visit 5) and Week 56 (Visit 9) - FAS'}, {'measure': 'Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline', 'timeFrame': 'Through study completion, until Week 56 (Week 9)', 'description': 'Proportion of patients who gain or lose ≥ 5, 10, or 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS'}, {'measure': 'Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Percentage of patients with fluid-free macula at Baseline (Visit 1), Week 24 (Visit 5), Week 56 (Visit 9) - FAS'}, {'measure': 'Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)', 'timeFrame': 'At Baseline and Visit 3a (48 hours after the 3rd dose)', 'description': 'Systemic concentrations (close to maximum concentration \\[Cmax\\]) of free aflibercept in a subgroup at selected sites - PKS:\n\n\\- 48 hours after the 3rd dose (Visit 3a)'}, {'measure': 'Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Change from Baseline Visit (Visit 1) in vision-related functioning and well-being measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS. The NEI VFQ-25 includes 12 subscales (e.g., general vision, ocular pain, driving, peripheral vision) scored from 0 to 100, where higher scores indicate better functioning. Subscales are averaged to produce a composite score, excluding the general health subscale. Both subscale and composite scores range from 0 (worst) to 100 (best), representing the percentage of the highest possible score achieved.'}, {'measure': 'Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Number of patients with anti-drug antibodies (ADAs) at Baseline (Visit 1), Week 24 (Visit 5) and Week 56 (Visit 9) - SAF'}, {'measure': 'Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Through study completion, until Week 56 (Visit 9)', 'description': 'Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) - SAF'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 50 years at Screening.\n* Male or female:\n\n * Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n 1. Not a woman of childbearing potential (WOCBP), OR\n 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Willingness and ability to undertake all scheduled visits and assessments.\n* Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD\n\nExclusion Criteria:\n\nPatients are not eligible for the study if any of the following criteria apply:\n\n* Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.\n* Study eye requiring immediate treatment.\n* Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.\n* Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure \\[IOP\\] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).\n* Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.\n* Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.\n* Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer.\n* Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.\n* Stroke or myocardial infarction within 6 months prior to randomization.\n* Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.'}, 'identificationModule': {'nctId': 'NCT04522167', 'acronym': 'MAGELLAN-AMD', 'briefTitle': 'Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioeq GmbH'}, 'officialTitle': 'A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'FYB203-03-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FYB203 (Proposed aflibercept biosimilar)', 'description': 'Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.', 'interventionNames': ['Drug: FYB203 (Proposed aflibercept biosimilar)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eylea® (Aflibercept)', 'description': 'Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.', 'interventionNames': ['Drug: Eylea® (Aflibercept)']}], 'interventions': [{'name': 'FYB203 (Proposed aflibercept biosimilar)', 'type': 'DRUG', 'description': 'Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.', 'armGroupLabels': ['FYB203 (Proposed aflibercept biosimilar)']}, {'name': 'Eylea® (Aflibercept)', 'type': 'DRUG', 'description': 'Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.', 'armGroupLabels': ['Eylea® (Aflibercept)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Sokolov', 'country': 'Czechia', 'facility': 'Research 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{'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Udine', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Amagasaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Asahikawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Chiyoda City', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.68449, 'lon': 139.75056}}, {'city': 'Chūō', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Hamamatsu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Himeji', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'city': 'Hirakata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Kita-ku', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.75264, 'lon': 139.73348}}, {'city': 'Kurume', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Meguro City', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6322, 'lon': 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{'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'city': 'Tarnów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kherson', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 46.63695, 'lon': 32.61458}}, {'city': 'Kropyvnytskyi', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 48.50834, 'lon': 32.26618}}, {'city': 'Lutsk', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}], 'overallOfficials': [{'name': 'Study Official', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bioeq GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioeq GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}