Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT02510794
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
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': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to approximately Month 38', 'description': 'Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 57, 'seriousNumAtRisk': 58, 'deathsNumAffected': 1, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 59, 'seriousNumAtRisk': 62, 'deathsNumAffected': 2, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 58, 'seriousNumAtRisk': 59, 'deathsNumAffected': 1, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 35, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'ANTERIOR CHAMBER CELL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'ANTERIOR CHAMBER FLARE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'BLEPHARITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CATARACT CORTICAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CATARACT NUCLEAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CHOROIDAL DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CHOROIDAL NEOVASCULARISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CONJUNCTIVAL BLEB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CONJUNCTIVAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 53, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 54, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 38, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CONJUNCTIVAL HYPERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CONJUNCTIVAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CORNEAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'DERMATOCHALASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'DIPLOPIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'EYE DISCHARGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'EYE IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'EYE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'EYELID OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'EYELID PTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'EYELIDS PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'FOREIGN BODY SENSATION IN EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'IRIDOCYCLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'IRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'LACRIMATION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'MACULAR DEGENERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'NEOVASCULAR AGE-RELATED MACULAR DEGENERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'OCULAR HYPERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'PHOTOPHOBIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'POSTERIOR CAPSULE OPACIFICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'PUNCTATE KERATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'RETINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'VISUAL ACUITY REDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'VITREOUS DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 9, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'INTERVERTEBRAL DISC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'ADENOCARCINOMA GASTRIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'BREAST CANCER RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'PANCREATIC CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CAROTID ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'HYPERTENSIVE ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'SUBARACHNOID HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'DEVICE DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'DEVICE MALFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'ACUTE KIDNEY INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'PROSTATOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'LUNG CONSOLIDATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'RESPIRATORY DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'AORTIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'FEMORAL ARTERY ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '6.93', 'upperLimit': '9.00'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '11.76', 'upperLimit': '24.61'}, {'value': '15.8', 'groupId': 'OG002', 'lowerLimit': '12.06', 'upperLimit': '20.63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 38 months', 'description': 'Protocol-Defined Refill Criteria\n\nAt 1 month after initial fill:\n\n* Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR\n* Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR\n* Presence of new macular hemorrhage, due to nAMD disease activity\n\nFor subsequent assessments:\n\n* Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR\n* Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR\n* Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR\n* Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR\n* Presence of new macular hemorrhage, due to nAMD disease activity', 'unitOfMeasure': 'Months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment, excluding 5 participants who were given surgery.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '-1.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '1.8'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '7.2'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '5.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 9, 10', 'description': 'Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.', 'unitOfMeasure': 'Units on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations:\n\n* At the time of an ITV anti-VEGF injection in study eye prior to Month 10.\n* Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment.\n* At the time of explant.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'groupId': 'OG000', 'lowerLimit': '-11.0', 'upperLimit': '-2.3'}, {'value': '-4.7', 'groupId': 'OG001', 'lowerLimit': '-8.8', 'upperLimit': '-0.6'}, {'value': '-4.9', 'groupId': 'OG002', 'lowerLimit': '-9.1', 'upperLimit': '-0.6'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '-2.6', 'upperLimit': '7.5'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '-0.6'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '0.4'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '3.5'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '-0.2', 'upperLimit': '4.2'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '1.0'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '1.0'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '4.1'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '4.7'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '0.7'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '0.8'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '5.1'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '-0.4', 'upperLimit': '4.3'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '0.8'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '1.4'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '5.8'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '5.3'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '2.3'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '0.8'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '6.4'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '-0.4', 'upperLimit': '5.7'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '1.4'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '0.3'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '6.1'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '6.1'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-0.1'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '1.0'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '6.2'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '5.9'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-5.7', 'upperLimit': '-0.9'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '1.7'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '7.3'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '6.6'}]}]}, {'title': 'Month 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-5.7', 'upperLimit': '-1.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '2.0'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '7.3'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '-0.2', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Month 10', 'description': 'Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.', 'unitOfMeasure': 'Units on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations:\n\n* At the time of an ITV anti-VEGF injection in study eye prior to Month 10.\n* Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment.\n* At the time of explant.'}, {'type': 'SECONDARY', 'title': 'Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.5', 'spread': '74.0', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '59.1', 'groupId': 'OG001'}, {'value': '29.7', 'spread': '54.7', 'groupId': 'OG002'}, {'value': '21.3', 'spread': '65.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Month 10', 'description': 'Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations:\n\n* At the time of an ITV anti-VEGF injection in study eye prior to Month 10.\n* Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment.\n* At the time of explant.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '29.0'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '-4.5', 'upperLimit': '18.9'}, {'value': '-2.9', 'groupId': 'OG002', 'lowerLimit': '-15.1', 'upperLimit': '9.2'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '-11.7', 'upperLimit': '16.7'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '32.7'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '24.1'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-14.5', 'upperLimit': '10.9'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '-13.3', 'upperLimit': '16.4'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '38.3'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '-5.5', 'upperLimit': '20.0'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '-6.8', 'upperLimit': '19.6'}, {'value': '-7.3', 'groupId': 'OG003', 'lowerLimit': '-22.9', 'upperLimit': '8.3'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '46.1'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '-10.3', 'upperLimit': '18.5'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '-13.2', 'upperLimit': '16.9'}, {'value': '-1.7', 'groupId': 'OG003', 'lowerLimit': '-19.2', 'upperLimit': '15.9'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '45.7'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-13.6', 'upperLimit': '14.5'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '-6.7', 'upperLimit': '22.9'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '-13.0', 'upperLimit': '21.1'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '48.1'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '-13.1', 'upperLimit': '17.3'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '-10.0', 'upperLimit': '21.7'}, {'value': '-2.0', 'groupId': 'OG003', 'lowerLimit': '-20.4', 'upperLimit': '16.4'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '54.3'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-12.5', 'upperLimit': '14.0'}, {'value': '-4.3', 'groupId': 'OG002', 'lowerLimit': '-18.3', 'upperLimit': '9.6'}, {'value': '-9.8', 'groupId': 'OG003', 'lowerLimit': '-25.9', 'upperLimit': '6.3'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42.8', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '59.1'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '-12.1', 'upperLimit': '18.3'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '-10.6', 'upperLimit': '20.8'}, {'value': '-2.4', 'groupId': 'OG003', 'lowerLimit': '-20.8', 'upperLimit': '16.1'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '37.1', 'upperLimit': '72.4'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-16.9', 'upperLimit': '15.5'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-18.5', 'upperLimit': '15.1'}, {'value': '-6.3', 'groupId': 'OG003', 'lowerLimit': '-26.1', 'upperLimit': '13.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Month 9', 'description': 'Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea', 'unitOfMeasure': 'microns', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population defined as all participants who received at least one study treatment. Here, "Number of Participants analyzed" indicates Number of Participants Included in MMRM Analysis. Assessments are censored for PDS participants meeting the following situations:\n\n* At the time of an ITV anti-VEGF injection in study eye prior to Month 10.\n* Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment.\n* At the time of explant.'}, {'type': 'SECONDARY', 'title': 'Number of Implant Clogging at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment.'}, {'type': 'SECONDARY', 'title': 'Observed Maximum Serum Concentration (Cmax) of Ranibizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Interval following implant insertion before first refill', 'categories': [{'measurements': [{'value': '105.52', 'spread': '258.0', 'groupId': 'OG000'}, {'value': '220.87', 'spread': '46.4', 'groupId': 'OG001'}, {'value': '1080.69', 'spread': '272.5', 'groupId': 'OG002'}]}]}, {'title': 'All Dose Intervals', 'categories': [{'measurements': [{'value': '91.47', 'spread': '187.2', 'groupId': 'OG000'}, {'value': '297.61', 'spread': '115.2', 'groupId': 'OG001'}, {'value': '1131.01', 'spread': '256.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'description': 'The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Interval following implant insertion before first refill', 'categories': [{'measurements': [{'value': '5.89', 'spread': '225.1', 'groupId': 'OG000'}, {'value': '28.39', 'spread': '107.6', 'groupId': 'OG001'}, {'value': '90.83', 'spread': '64.7', 'groupId': 'OG002'}]}]}, {'title': 'All Dose Intervals', 'categories': [{'measurements': [{'value': '3.43', 'spread': '176.8', 'groupId': 'OG000'}, {'value': '22.93', 'spread': '96.9', 'groupId': 'OG001'}, {'value': '66.12', 'spread': '71.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field)', 'description': 'AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.', 'unitOfMeasure': 'ng∙day/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of Ranibizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Interval following implant insertion before first refill', 'categories': [{'measurements': [{'value': '11.45', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '688.1'}, {'value': '12.87', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '86.0'}, {'value': '29.01', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '180.3'}]}]}, {'title': 'All Dose Intervals', 'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '688.1'}, {'value': '6.71', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '91.1'}, {'value': '6.97', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '180.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'description': 'The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of Ranibizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Interval following implant insertion before first refill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '168.20', 'spread': '163.3', 'groupId': 'OG000'}, {'value': '88.30', 'spread': '46.7', 'groupId': 'OG001'}, {'value': '119.07', 'spread': '128.4', 'groupId': 'OG002'}]}]}, {'title': 'All Dose Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '162.36', 'spread': '129.3', 'groupId': 'OG000'}, {'value': '118.87', 'spread': '76.2', 'groupId': 'OG001'}, {'value': '143.87', 'spread': '171.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'description': 'The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.', 'unitOfMeasure': 'days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)'}, {'type': 'SECONDARY', 'title': 'Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Interval following implant insertion before first refill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.96', 'spread': '76.4', 'groupId': 'OG000'}, {'value': '61.64', 'spread': '95.8', 'groupId': 'OG001'}, {'value': '129.63', 'spread': '149.2', 'groupId': 'OG002'}]}]}, {'title': 'All Dose Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.58', 'spread': '65.7', 'groupId': 'OG000'}, {'value': '105.07', 'spread': '77.4', 'groupId': 'OG001'}, {'value': '62.19', 'spread': '345.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Ranibizumab PD All Participants', 'description': 'Participants had the Implant (prefilled with approximately 20 μL either the 10 mg/mL \\[approximately 0.2 mg dose\\], 40 mg/mL \\[approximately 0.8 mg dose\\], or 100 mg/mL formulation \\[approximately 2-mg dose\\] of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10 mg/mL, 40 mg/mL, or 100 mg/mL formulations of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG004', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Participants with ocular SAEs in study eye', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Participants with ocular AEs in study eye', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'Participants with non-ocular SAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Participants with non-ocular AEs', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Month 38', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyses were based on the Safety Population which was composed of participants receiving at least one study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Serum Antibodies to Ranibizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG003', 'title': 'Ranibizumab PD All Participants', 'description': 'Participants had the Implant (prefilled with approximately 20 μL either the 10 mg/mL \\[approximately 0.2 mg dose\\], 40 mg/mL \\[approximately 0.8 mg dose\\], or 100 mg/mL formulation \\[approximately 2-mg dose\\] of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10 mg/mL, 40 mg/mL, or 100 mg/mL formulations of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'OG004', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'classes': [{'title': 'Participants with a positive sample at time of entry into the study (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}, {'value': '6.8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Participants positive for Treatment Emergent ADA (Post-baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}, {'value': '15.3', 'groupId': 'OG002'}, {'value': '12.3', 'groupId': 'OG003'}, {'value': '14.6', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 38 months', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyses were based on the Safety Population which was composed of participants receiving at least one study treatment. Here, number of analyzed participants represents number of participants from whom samples were collected and analyzed. Baseline evaluable participant is a participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant is a participant with an ADA assay result from at least one post-baseline sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'FG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'FG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'FG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant moved out of the area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "Participants with subfoveal neovascularization secondary to AMD diagnosed within 9 months and treated with ITV anti-VEGF agents were enrolled in the study. Written informed consent was obtained before initiation of any study-related procedures. A participant's screening occurred no sooner than 7 days following administration of the last ITV ranibizumab treatment to the study eye. The screening visit was followed by the randomization visit."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Port Delivery System With Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'BG001', 'title': 'Port Delivery System With Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'BG002', 'title': 'Port Delivery System With Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.'}, {'id': 'BG003', 'title': 'Intravitreal Injection With Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '194', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '75.0', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '73.8', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '71.9', 'spread': '8.8', 'groupId': 'BG003'}, {'value': '74.0', 'spread': '8.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '211', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], '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': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-07', 'size': 2501783, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-23T17:23', 'hasProtocol': True}, {'date': '2018-06-21', 'size': 901876, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-23T17:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2019-04-10', 'completionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2015-07-17', 'dispFirstSubmitQcDate': '2019-04-18', 'resultsFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2015-07-27', 'dispFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-12', 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria', 'timeFrame': 'Baseline up to approximately 38 months', 'description': 'Protocol-Defined Refill Criteria\n\nAt 1 month after initial fill:\n\n* Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR\n* Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR\n* Presence of new macular hemorrhage, due to nAMD disease activity\n\nFor subsequent assessments:\n\n* Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR\n* Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR\n* Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR\n* Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR\n* Presence of new macular hemorrhage, due to nAMD disease activity'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10', 'timeFrame': 'Baseline, Months 9, 10', 'description': 'Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.'}, {'measure': 'Change From Baseline in BCVA Over Time', 'timeFrame': 'Baseline up to Month 10', 'description': 'Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.'}, {'measure': 'Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis)', 'timeFrame': 'Baseline up to Month 10', 'description': 'Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).'}, {'measure': 'Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)', 'timeFrame': 'Baseline up to Month 9', 'description': 'Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea'}, {'measure': 'Number of Implant Clogging at Month 9', 'timeFrame': 'Month 9', 'description': 'Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.'}, {'measure': 'Observed Maximum Serum Concentration (Cmax) of Ranibizumab', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'description': 'The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.'}, {'measure': 'Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab', 'timeFrame': 'Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field)', 'description': 'AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.'}, {'measure': 'Time to Maximum Concentration (Tmax) of Ranibizumab', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'description': 'The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.'}, {'measure': 'Terminal Half-Life (t1/2) of Ranibizumab', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months', 'description': 'The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.'}, {'measure': 'Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab', 'timeFrame': 'Predose (0 hour) on Day 1 up to 38 months'}, {'measure': 'Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)', 'timeFrame': 'Baseline up to approximately Month 38'}, {'measure': 'Percentage of Participants With Positive Serum Antibodies to Ranibizumab', 'timeFrame': 'Baseline up to 38 months'}]}, 'conditionsModule': {'conditions': ['Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '39209113', 'type': 'DERIVED', 'citation': 'Campochiaro PA, Eichenbaum D, Chang MA, Clark WL, Graff JM, Le Pogam S, Cavichini Cordeiro M, Gune S, Rabena M, Singh N, Lin S, Callaway N. Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2025 Feb;9(2):144-155. doi: 10.1016/j.oret.2024.05.021. Epub 2024 Aug 30.'}, {'pmid': '35759124', 'type': 'DERIVED', 'citation': 'Wykoff CC, Campochiaro PA, Pieramici DJ, Khanani AM, Gune S, Maia M, Kagedal M, Ding HT, Maass KF. Pharmacokinetics of the Port Delivery System with Ranibizumab in the Ladder Phase 2 Trial for Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2022 Oct;11(5):1705-1717. doi: 10.1007/s40123-022-00532-9. Epub 2022 Jun 27.'}, {'pmid': '35589078', 'type': 'DERIVED', 'citation': 'Awh CC, Barteselli G, Makadia S, Chang RT, Stewart JM, Wieland MR, Brassard R, Callaway NF, Gune S, Heatherton P, Malhotra V, Willis JR, Pieramici DJ. Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab. Ophthalmol Retina. 2022 Nov;6(11):1028-1043. doi: 10.1016/j.oret.2022.05.011. Epub 2022 May 16.'}, {'pmid': '35248647', 'type': 'DERIVED', 'citation': 'Yohe S, Maass KF, Horvath J, Rea J, Barteselli G, Ranade SV. In-vitro characterization of ranibizumab release from the Port Delivery System. J Control Release. 2022 May;345:101-107. doi: 10.1016/j.jconrel.2022.03.005. Epub 2022 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal neovascular age-related macular degeneration (nAMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed with wet AMD within 9 months of screening visit\n* Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit\n* Demonstrated response to prior ITV anti-VEGF treatment\n* Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent\n\nExclusion Criteria:\n\n* Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye\n* Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit\n* History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye\n* Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit\n* Subretinal hemorrhage in the study eye that involves the center of the fovea\n* Subfoveal fibrosis, or atrophy in the study eye\n* Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia\n* Uncontrolled ocular hypertension or glaucoma in the study eye\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye\n* Uncontrolled blood pressure\n* Uncontrolled atrial fibrillation within 3 months of informed consent\n* History of myocardial infarction or stroke within the last 3 months prior to informed consent\n* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications\n* Use of oral corticosteroids\n* Current treatment for any active systemic infection\n* Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects\n* Active malignancy within 12 months of randomization\n* History of allergy to fluorescein\n* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)'}, 'identificationModule': {'nctId': 'NCT02510794', 'acronym': 'LADDER', 'briefTitle': 'Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'GX28228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Port Delivery System with Ranibizumab 10mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Port Delivery System with Ranibizumab 40mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Port Delivery System with Ranibizumab 100mg/mL', 'description': 'Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravitreal Injection with Ranibizumab 0.5mg', 'description': 'Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.', 'interventionNames': ['Drug: Ranibizumab']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis®'], 'description': 'Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations.', 'armGroupLabels': ['Intravitreal Injection with Ranibizumab 0.5mg', 'Port Delivery System with Ranibizumab 100mg/mL', 'Port Delivery System with Ranibizumab 10mg/mL', 'Port Delivery System with Ranibizumab 40mg/mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barnet Dulaney Perkins Eye Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'The Retina Partners', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Jacobs Retina center at the Shiley eye Institute UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095-7000', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jules Stein Eye Institute/ UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'N CA Retina Vitreous Assoc', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Consultants Med Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Retina Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF; 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