Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04418427
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2020-05-28
Is Possible Gene Therapy:
True
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ADVM-022 Intravitreal Gene Therapy for DME
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@adverum.com', 'phone': '650-656-9323', 'title': 'Study Medical Director', 'organization': 'Adverum Biotechnologies'}, 'certainAgreement': {'otherDetails': 'Investigators agreed to postponement of single-site study publications until after publication of all multi-center study results, until notification by the Sponsor that a multi-center publication is not planned, or until eighteen (18) months after final database lock.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Although this study was initiated as a randomized, double-masked study, the Sponsor and the independent data monitoring committee agreed to unmask the study following an ocular suspected unexpected serious adverse reaction (SUSAR) of Hypotony and concerns regarding the appropriate management of ocular inflammation and hypotony. All participants had reached the 12-week assessment at the time of unmasking.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data are presented from study treatment on Day 1 through Week 96.', 'description': 'The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).', 'eventGroups': [{'id': 'EG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Abdominal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iridocyclitis', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Anterior chamber cell', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iris transillumination defect', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iris adhesions', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ocular hypertension', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Conjunctival haemorrhage', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic retinal oedema', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pigment dispersion syndrome', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cataract', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Keratic precipitates', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreous floaters', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cataract subcapsular', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iris hyperpigmentation', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iritis', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Uveitis', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Decrease in intraocular pressure', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Corneal striae', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Punctate keratitis', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Anterior chamber flare', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Lenticular pigmentation', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreous detachment', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Corneal oedema', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Flat anterior chamber of eye', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iris atrophy', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Mydriasis', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Posterior capsule opacification', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreous haemorrhage', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreous opacities', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ocular hypotension', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vision blurred', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cataract nuclear', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Chalazion', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ciliary body disorder', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Conjunctivitis allergic', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Corneal erosion', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic retinopathy', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Epiretinal membrane', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Eyelid margin crusting', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Eyelid ptosis', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Foreign body sensation in eyes', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypotony', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypotony maculopathy', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'IOP 5mmHG Post injection', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Narrow anterior chamber angle', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ocular discomfort', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Periorbital oedema', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Periorbital pain', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Photophobia', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Swelling of eyelid', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Visual impairment', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreal cells', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreoretinal traction syndrome', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitreous haze', 'notes': 'Ocular AEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Urinary tract infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hyphaema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Degenerative bone disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cerebral ventricle dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Renal atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pelvic fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Lung opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gastrooesophageal hypot disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'seriousEvents': [{'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cataract', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cataract subcapsular', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Visual impairment', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypotony of eye', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Iridocyclitis', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Angle closure glaucoma', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cataract nuclear', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Choroidal effusion', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cystoid macular oedema', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vitritis', 'notes': 'Ocular SAEs are presented for the Study Eye only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Worsening of DME Disease Activity in the Study Eye.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Study Eyes', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '82.1', 'comment': 'The upper limit of the 90% confidence interval was not calculable because an insufficient number of participants experienced the event by the final time point for assessment.', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': 'NA'}, {'value': '96.1', 'comment': 'The upper limit of the 90% confidence interval was not calculable because an insufficient number of participants experienced the event by the final time point for assessment.', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': 'NA'}, {'value': '19.1', 'groupId': 'OG002', 'lowerLimit': '12.7', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Time to worsening of DME disease activity in the study eye through 96 weeks.\n\nTime to worsening of DME disease activity defined by either: An increase in CST \\> 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of \\> 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.', 'unitOfMeasure': 'Weeks', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Study Eyes', 'denomUnitsSelected': 'Study Eyes', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]).'}, {'type': 'SECONDARY', 'title': 'Incidence of Ocular Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '96 weeks', 'description': 'Incidence of ocular adverse events (AEs) through 96 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: participants who received treatment on Day 1 (aflibercept or Sham) and Day 8 (Ixo-vec or Sham) analyzed based on treatments they received on Days 1 and 8. Ocular adverse events are presented for the Study Eye only.\n\nNote: two participants who were discontinued prior to Day 8 are not included in the mITT population. These two participants reported no adverse events.'}, {'type': 'SECONDARY', 'title': 'Incidence of Non-ocular Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Incidence of non-ocular adverse events (AEs) through 96 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: participants who received treatment on Day 1 (aflibercept or Sham) and Day 8 (Ixo-vec or Sham) analyzed based on treatments they received on Days 1 and 8.\n\nNote: two participants who were discontinued prior to Day 8 are not included in the mITT population. These two participants reported no adverse events.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Central Subfield Thickness (CST) in Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Study Eyes', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '-84.4', 'groupId': 'OG000', 'lowerLimit': '-124.0', 'upperLimit': '-44.9'}, {'value': '-129.7', 'groupId': 'OG001', 'lowerLimit': '-172.2', 'upperLimit': '-87.3'}, {'value': '-129.7', 'groupId': 'OG002', 'lowerLimit': '-176.9', 'upperLimit': '-82.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 96 weeks', 'description': 'Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Least squares mean change from Baseline in central subfield thickness at Week 96 is presented for the study eye.', 'unitOfMeasure': 'micrometers', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Study Eyes', 'denomUnitsSelected': 'Study Eyes', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Study Eyes', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.9', 'groupId': 'OG000', 'lowerLimit': '-20.7', 'upperLimit': '-3.2'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '19.8'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '27.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '96 weeks', 'description': 'Least squares mean change from Baseline in BCVA score over time was measured over time through week 96 in the study eye by ETDRS letters.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Study Eyes', 'denomUnitsSelected': 'Study Eyes', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]).'}, {'type': 'SECONDARY', 'title': 'Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Study Eyes', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '1.001', 'groupId': 'OG000', 'lowerLimit': '0.022', 'upperLimit': '1.979'}, {'value': '0.423', 'groupId': 'OG001', 'lowerLimit': '0.055', 'upperLimit': '0.792'}, {'value': '5.54', 'groupId': 'OG002', 'lowerLimit': '3.058', 'upperLimit': '8.029'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Frequency of supplemental aflibercept (2 mg IVT) injections was assessed in the study eye over time during the study.\n\nParticipants were analyzed according to the study treatments they actually received on Days 1 and 8.\n\nThe rate of supplemental aflibercept per year = Total number of supplemental aflibercept injections / Total years at-risk (at-risk duration starting at Day 8).', 'unitOfMeasure': 'Injections/year', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Study Eyes', 'denomUnitsSelected': 'Study Eyes', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]).'}, {'type': 'SECONDARY', 'title': 'Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step improvement indicates an improvement in a participant across 2 steps of the 13-step scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants treated on both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]). Only mITT participants whose Baseline Score permitted a ≥ 2 step DRSS improvement were eligible for this analysis. The incidence of 2-step improvement in DRSS score over time at Week 96 is presented.'}, {'type': 'SECONDARY', 'title': 'Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 3-step improvement indicates an improvement in a participant across 3 steps of the 13-step scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants treated on both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]). Only mITT participants whose Baseline Score permitted a ≥3 step DRSS improvement were eligible for this analysis. The incidence of 3-step improvement in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater improvement in DRSS were considered separate events.'}, {'type': 'SECONDARY', 'title': 'Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step worsening indicates a worsening across 2 steps of the 13-step scale.\n\nNote: 2-step worsening in DRSS was observed in 2 participants in both the control arm and the ADVM-022 6E11 vg/eye arm. These participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]). The incidence of 2-step worsening in DRSS score over time at Week 96 is presented. Visits with a 2-step or greater worsening in DRSS were considered separate events.'}, {'type': 'SECONDARY', 'title': 'Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 with higher scored indicating more advanced stages of Diabetic Retinopathy. The incidence of 3-step worsening in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater worsening in DRSS were considered separate events.\n\nNote: 3-step worsening in DRSS was observed in one participant each in the control arm and the ADVM-022 6E11 vg/eye arm. Both participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]).'}, {'type': 'SECONDARY', 'title': 'Occurrence of Any Vision Threatening Complications in the Study Eye (Anterior Segment Neovascularization, Vitreous Hemorrhage, or Any Other High-risk Proliferative DR, or Tractional Retinal Detachment) Over Time Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Occurrence of any vision threatening complication over time though 96 weeks. Results present the incidence of participants who experienced "Any Vision Threatening Complications" (defined as any Vitreous Haemorrhage adverse event (AE), Anterior Segment Neovascularization AE, High-risk proliferative DR (defined as DSSR \\>= 71), or Tractional Retinal Detachment AE) in the study eye from Day 1 through 96 weeks.\n\nNote: AEs of Vitreous Haemorrhage and High-risk proliferative DR were reported in 1 participant in the control arm and in 2 separate participants in the 6E11 vg/eye arm. No AE of Tractional Retinal Detachment or Anterior Segment Neovascularization occurred.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]).'}, {'type': 'SECONDARY', 'title': 'Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'OG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Incidence of participants with Central subfield thickness of less than 300 μm over time in the study eye through Week 96 is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \\[Aflibercept or Sham\\] and Day 8 \\[Ixo-vec or Sham\\]). Incidence through last visit represent the last visit through Week 96 with non-missing CST data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'FG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'FG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Modified ITT (mITT) Population', 'comment': 'The modified ITT (mITT) population included all randomized participants who received study treatment at both Day 1 (Aflibercept or Sham) and Day 8 (ADVM-022 or Sham). Two participants (1 randomized to ADVM-022-6E11 vg/Eye and 1 randomized to Aflibercept + Sham) treated on Day 1 were withdrawn by the Sponsor prior to Day 8 due to the syringe manufacturer warning letter (in the UK) advising against intra-ocular use. These two participants are not included in mITT. They reported no adverse events.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject Discontinued by the Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pre-existing medical condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two doses of ADVM-022 (Ixo-vec) were investigated, administered with or without a prior loading dose of Aflibercept. The control group received the initial loading dose of Aflibercept (Day 1) but received a Sham injection on Day 8 instead of Ixo-vec. Only one eye was selected as the study eye. After the assigned intravitreal (IVT) injections on Days 1 and 8, clinic visits were on Weeks 2, 4, and every 4 weeks up to Week 96. Consenting participants then entered a long-term follow-up study.', 'preAssignmentDetails': 'Participants with initial diagnosis of DME within 6 months of screening, and who had received up to 2 prior injections of anti-VEGF therapy in the study eye (0, 1 or 2) were eligible for enrollment. If a prior anti-VEGF had been administered to the study eye, in the judgement of the Investigator, there must have been a meaningful CST response (e.g., ≥ 10% reduction) and no adverse reaction to the anti-VEGF (e.g., intraocular inflammation).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ADVM-022 6E11 vg/Eye', 'description': '6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'BG001', 'title': 'ADVM-022 2E11 vg/Eye', 'description': '2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT\n\n2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'BG002', 'title': 'Aflibercept + Sham', 'description': 'Aflibercept 2mg IVT\n\nAflibercept: Commercially available Active Comparator'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '5.94', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '8.28', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '5.68', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '7.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT (Intent to Treat) Population included all participants randomized to treatment. Participants were analyzed as randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-05', 'size': 2314708, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-17T14:44', 'hasProtocol': True}, {'date': '2022-11-28', 'size': 2013400, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-17T14:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "From May 2020 through April 2021: Double-masked study - participants, outcomes assessors and the designated masked study personnel were to have been masked to subject's treatment assignment throughout the study. There must have been a minimum of two physicians per site to fulfill the masking requirements of the study. A masked and unmasked investigator were required to be present for administration of the preceding dose of aflibercept or sham and following dose of ADVM-022 or sham visits, thereafter only the masked investigator was required to be present.\n\nStarting April 2021: Open label study - study was unmasked for enhanced safety monitoring."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-21', 'studyFirstSubmitDate': '2020-05-28', 'resultsFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-21', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Worsening of DME Disease Activity in the Study Eye.', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Time to worsening of DME disease activity in the study eye through 96 weeks.\n\nTime to worsening of DME disease activity defined by either: An increase in CST \\> 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of \\> 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Ocular Adverse Events (AEs)', 'timeFrame': '96 weeks', 'description': 'Incidence of ocular adverse events (AEs) through 96 weeks'}, {'measure': 'Incidence of Non-ocular Adverse Events (AEs)', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Incidence of non-ocular adverse events (AEs) through 96 weeks.'}, {'measure': 'Change From Baseline Central Subfield Thickness (CST) in Study Eye', 'timeFrame': 'Baseline through 96 weeks', 'description': 'Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Least squares mean change from Baseline in central subfield thickness at Week 96 is presented for the study eye.'}, {'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye', 'timeFrame': '96 weeks', 'description': 'Least squares mean change from Baseline in BCVA score over time was measured over time through week 96 in the study eye by ETDRS letters.'}, {'measure': 'Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Frequency of supplemental aflibercept (2 mg IVT) injections was assessed in the study eye over time during the study.\n\nParticipants were analyzed according to the study treatments they actually received on Days 1 and 8.\n\nThe rate of supplemental aflibercept per year = Total number of supplemental aflibercept injections / Total years at-risk (at-risk duration starting at Day 8).'}, {'measure': 'Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step improvement indicates an improvement in a participant across 2 steps of the 13-step scale.'}, {'measure': 'Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 3-step improvement indicates an improvement in a participant across 3 steps of the 13-step scale.'}, {'measure': 'Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step worsening indicates a worsening across 2 steps of the 13-step scale.\n\nNote: 2-step worsening in DRSS was observed in 2 participants in both the control arm and the ADVM-022 6E11 vg/eye arm. These participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation).'}, {'measure': 'Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 with higher scored indicating more advanced stages of Diabetic Retinopathy. The incidence of 3-step worsening in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater worsening in DRSS were considered separate events.\n\nNote: 3-step worsening in DRSS was observed in one participant each in the control arm and the ADVM-022 6E11 vg/eye arm. Both participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation).'}, {'measure': 'Occurrence of Any Vision Threatening Complications in the Study Eye (Anterior Segment Neovascularization, Vitreous Hemorrhage, or Any Other High-risk Proliferative DR, or Tractional Retinal Detachment) Over Time Through Week 96', 'timeFrame': 'From Day 1 through 96 weeks', 'description': 'Occurrence of any vision threatening complication over time though 96 weeks. Results present the incidence of participants who experienced "Any Vision Threatening Complications" (defined as any Vitreous Haemorrhage adverse event (AE), Anterior Segment Neovascularization AE, High-risk proliferative DR (defined as DSSR \\>= 71), or Tractional Retinal Detachment AE) in the study eye from Day 1 through 96 weeks.\n\nNote: AEs of Vitreous Haemorrhage and High-risk proliferative DR were reported in 1 participant in the control arm and in 2 separate participants in the 6E11 vg/eye arm. No AE of Tractional Retinal Detachment or Anterior Segment Neovascularization occurred.'}, {'measure': 'Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye', 'timeFrame': 'Day 1 through 96 weeks', 'description': 'Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Incidence of participants with Central subfield thickness of less than 300 μm over time in the study eye through Week 96 is presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADVM-022', 'ADVM-022-04', 'AAV.7m8', 'Anti-VEGF therapy', 'Blindness', 'INFINITY', 'Gene therapy', 'Aflibercept (Eylea)', 'Retinal Diseases', 'Eye Diseases', 'AAV Vector', 'Adverum', 'DME', 'Diabetic macular edema', 'Diabetic eye disease', 'Diabetic retinopathy', 'DR', 'AAV.7m8-aflibercept', 'Ixoberogene soroparvovec', 'Ixo-vec'], 'conditions': ['Diabetic Macular Edema', 'Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'A Phase 2, Multi-Center, Randomized, Double-Masked\\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \\[INFINITY\\]', 'detailedDescription': 'ADVM-022 (also known as Ixo-vec and AAV.7m8-aflibercept) is an investigational gene therapy product developed for the treatment of serious retinal vascular diseases including Diabetic Macular Edema (DME), a vision-threatening complication of diabetic retinopathy. DME can affect up to 10% of individuals with both type 1 and type 2 diabetes mellitus. Current therapies for treating DME include anti-vascular endothelial growth factor (anti-VEGF) agents that require frequent and long-term intravitreal (IVT) injections to achieve and maintain efficacy. ADVM-022 is intended provide sustained intraocular expression of aflibercept from a single IVT injection to potentially reduce the current treatment burden and prevent disease progression and vision loss due to undertreatment.\n\nThis Phase 2, randomized, controlled study (INFINITY) enrolled 36 eligible participants with DME. The participants were randomized to receive one of the two dose levels of ADVM-022 or assigned to the control arm to receive a sham ocular injection with a preceding aflibercept injection. Participants randomized to the ADVM-022 arms were assigned to receive a preceding aflibercept or sham ocular injection. All participants were monitored regularly for disease activity and may have received supplemental aflibercept based on predefined retreatment criteria. All participants were to be followed over a 96- week follow-up period.\n\nTo enhance safety monitoring for participants in this study, the sponsor unmasked treatment assignment (in April 2021) due to the occurrence of a suspected unexpected serious adverse reaction (SUSAR) which occurred early in the study in the high dose (ADVM-022 6E11 vg/eye) arm. Interpretation of the results of this study should consider the potential confounding nature of this unmasking in the context of the observed dose-limiting events and the associated additional use of topical/intravitreal/systemic steroids, particularly in the high dose ADVM-022 arm.\n\nIn this study ADVM-022 (Ixo-vec) demonstrated improved efficacy across endpoints, reducing the need for supplemental aflibercept in DME management and demonstrating a clinically meaningful delay in DME worsening and improved outcomes across multiple endpoints compared to the control arm (sham + Aflibercept). However, the benefit of the ADVM-022 6E11 vg/eye dose was affected by dose-limiting toxicities in some participants. In terms of safety outcomes, the most common ADVM-022-related adverse events were mild-to-moderate intraocular inflammation, a known and expected side effect of ocular gene therapy, which was generally responsive to corticosteroid eye drops. No Ixo-vec-related events were reported in the fellow eye or systemically, indicating no off-target effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Type 1 or Type 2 diabetes mellitus\n* Willing and able to provide informed consent\n* Vision impairment due to center involving diabetic macular edema\n\nExclusion Criteria:\n\n* Uncontrolled diabetes defined as HbA1C \\>10%, or history of diabetic ketoacidosis within 3 months prior to randomization; or subjects who, within the last 3 months, initiated intensive insulin treatment (a pump or multiple daily injection) or plan to do so in the next 3 months.\n* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months\n* Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg\n* Known severe renal impairment\n* High risk Proliferative Diabetic Retinopathy\n* History of retinal disease in the study eye other than diabetic retinopathy\n* History of retinal detachment (with or without repair) in the study eye\n* History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye\n* Any prior focal or grid laser photocoagulation or any prior PRP in the study eye\n* Current or planned pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04418427', 'acronym': 'INFINITY', 'briefTitle': 'ADVM-022 Intravitreal Gene Therapy for DME', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adverum Biotechnologies, Inc.'}, 'officialTitle': 'A Phase 2, Multi-Center, Randomized, Double-Masked, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects With Diabetic Macular Edema [INFINITY]', 'orgStudyIdInfo': {'id': 'ADVM-022-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '6E11 vg/eye ADVM-022 +/- 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