Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-09 @ 6:19 AM
Study NCT ID:
NCT03846193
Status:
TERMINATED
Last Update Posted:
2025-08-24
First Post:
2019-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D057088', 'term': 'Anetoderma'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Overall', 'description': 'Overall', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 54, 'seriousNumAtRisk': 56, 'deathsNumAffected': 4, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Corneal dystrophy - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Corneal dystrophy - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Anterior chamber cell - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blepharitis - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blepharitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cataract - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Central vision loss - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chalazion - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Charles Bonnet syndrome - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Charles Bonnet syndrome - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Choroidal haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Choroidal neovascularisation - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Choroidal neovascularisation - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Conjunctival deposit - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Conjunctival haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Conjunctival hyperaemia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Corneal oedema - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dacryostenosis acquired - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diplopia - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, 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'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'title': 'Subjects with at least one TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Congenital, familial and genetic disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Corneal dystrophy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': '-Retinal pigmentation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctival haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': '-Cataract', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Retinal haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': '-Dry eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Anterior chamber cell', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '-Retinal tear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': '-Blepharitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctival hyperaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Neovascular age-related macular degeneration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Visual field defect', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Charles Bonnet syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Eye pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Eyelid ptosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Visual acuity reduced', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Vitreous floaters', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Central vision loss', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Chalazion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Choroidal haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Choroidal neovascularisation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctival deposit', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Corneal oedema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Dacryostenosis acquired', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Diplopia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Eye discharge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Eye pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Eyelid irritation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Foreign body sensation in eyes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Glaucoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Iridocyclitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Keratitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Macular hole', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Ocular discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Ocular hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Optic disc haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Periorbital oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Posterior capsule opacification', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Retinal depigmentation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Vision blurred', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Visual impairment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctivitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctivitis viral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctivitis bacterial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '-Procedural pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Corneal abrasion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Post procedural discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Suture related complication', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Intraocular pressure increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Ophthalmic migraine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}, {'type': 'PRIMARY', 'title': 'Summary of Non-Ocular Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}, {'type': 'PRIMARY', 'title': 'Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.33', 'spread': '16.145', 'groupId': 'OG000'}, {'value': '47.20', 'spread': '16.151', 'groupId': 'OG001'}, {'value': '47.20', 'spread': '17.449', 'groupId': 'OG002'}, {'value': '62.00', 'spread': '17.436', 'groupId': 'OG003'}, {'value': '52.59', 'spread': '15.822', 'groupId': 'OG004'}]}]}, {'title': 'Week 5 (n=6,10,14,3,22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42.00', 'spread': '20.258', 'groupId': 'OG000'}, {'value': '46.90', 'spread': '13.916', 'groupId': 'OG001'}, {'value': '45.57', 'spread': '19.747', 'groupId': 'OG002'}, {'value': '62.67', 'spread': '19.425', 'groupId': 'OG003'}, {'value': '52.14', 'spread': '18.838', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (n=3,4,6,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60.33', 'spread': '9.074', 'groupId': 'OG000'}, {'value': '55.25', 'spread': '9.674', 'groupId': 'OG001'}, {'value': '55.67', 'spread': '12.675', 'groupId': 'OG002'}, {'value': '65.33', 'spread': '16.442', 'groupId': 'OG003'}, {'value': '52.52', 'spread': '18.101', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 (n=6,10,11,3,22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '44.33', 'spread': '21.153', 'groupId': 'OG000'}, {'value': '46.00', 'spread': '15.563', 'groupId': 'OG001'}, {'value': '54.73', 'spread': '16.032', 'groupId': 'OG002'}, {'value': '66.67', 'spread': '16.166', 'groupId': 'OG003'}, {'value': '54.68', 'spread': '17.705', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 (n=6,10,13,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42.67', 'spread': '24.262', 'groupId': 'OG000'}, {'value': '44.60', 'spread': '13.810', 'groupId': 'OG001'}, {'value': '48.92', 'spread': '20.056', 'groupId': 'OG002'}, {'value': '66.67', 'spread': '19.218', 'groupId': 'OG003'}, {'value': '52.76', 'spread': '18.144', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 (n=6,6,15,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.00', 'spread': '21.790', 'groupId': 'OG000'}, {'value': '53.17', 'spread': '12.983', 'groupId': 'OG001'}, {'value': '43.80', 'spread': '20.640', 'groupId': 'OG002'}, {'value': '65.00', 'spread': '21.932', 'groupId': 'OG003'}, {'value': '52.29', 'spread': '18.078', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 (n=5,9,14,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.60', 'spread': '19.204', 'groupId': 'OG000'}, {'value': '47.22', 'spread': '13.953', 'groupId': 'OG001'}, {'value': '47.86', 'spread': '16.176', 'groupId': 'OG002'}, {'value': '64.00', 'spread': '20.518', 'groupId': 'OG003'}, {'value': '51.19', 'spread': '19.577', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 (n=3,8,14,3,18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '32.67', 'spread': '20.744', 'groupId': 'OG000'}, {'value': '46.63', 'spread': '15.408', 'groupId': 'OG001'}, {'value': '46.93', 'spread': '13.658', 'groupId': 'OG002'}, {'value': '57.33', 'spread': '16.258', 'groupId': 'OG003'}, {'value': '51.72', 'spread': '18.162', 'groupId': 'OG004'}]}]}, {'title': 'Week 96 (n=4,8,14,3,18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31.00', 'spread': '21.494', 'groupId': 'OG000'}, {'value': '44.13', 'spread': '12.484', 'groupId': 'OG001'}, {'value': '43.57', 'spread': '18.110', 'groupId': 'OG002'}, {'value': '64.67', 'spread': '24.583', 'groupId': 'OG003'}, {'value': '51.72', 'spread': '19.393', 'groupId': 'OG004'}]}]}, {'title': 'Week 144 (n=2,6,10,3,2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.50', 'spread': '28.991', 'groupId': 'OG000'}, {'value': '42.50', 'spread': '9.628', 'groupId': 'OG001'}, {'value': '43.90', 'spread': '17.515', 'groupId': 'OG002'}, {'value': '64.00', 'spread': '18.520', 'groupId': 'OG003'}, {'value': '56.00', 'spread': '2.828', 'groupId': 'OG004'}]}]}, {'title': 'Week 192 (n=2,3,7,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.50', 'spread': '19.092', 'groupId': 'OG000'}, {'value': '35.33', 'spread': '8.505', 'groupId': 'OG001'}, {'value': '36.43', 'spread': '15.404', 'groupId': 'OG002'}]}]}, {'title': 'Week 240 (n=2,1,2,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.50', 'spread': '16.263', 'groupId': 'OG000'}, {'value': '28.00', 'groupId': 'OG001'}, {'value': '25.50', 'spread': '7.778', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 240', 'description': 'Best corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'ETDRS letters read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'title': 'Week 12 (n=3,9,11,3,22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.00', 'spread': '21.517', 'groupId': 'OG000'}, {'value': '14.67', 'spread': '17.951', 'groupId': 'OG001'}, {'value': '18.91', 'spread': '14.321', 'groupId': 'OG002'}, {'value': '28.67', 'spread': '17.214', 'groupId': 'OG003'}, {'value': '24.82', 'spread': '16.229', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 (n=6,10,13,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '32.25', 'spread': '29.205', 'groupId': 'OG000'}, {'value': '15.80', 'spread': '15.061', 'groupId': 'OG001'}, {'value': '17.23', 'spread': '13.893', 'groupId': 'OG002'}, {'value': '27.00', 'spread': '20.952', 'groupId': 'OG003'}, {'value': '22.52', 'spread': '14.473', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 (n=4,6,15,3,20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.75', 'spread': '24.865', 'groupId': 'OG000'}, {'value': '21.00', 'spread': '14.656', 'groupId': 'OG001'}, {'value': '15.07', 'spread': '15.144', 'groupId': 'OG002'}, {'value': '30.00', 'spread': '30.806', 'groupId': 'OG003'}, {'value': '20.10', 'spread': '14.242', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 (n=5,9,14,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.60', 'spread': '14.415', 'groupId': 'OG000'}, {'value': '15.11', 'spread': '13.968', 'groupId': 'OG001'}, {'value': '17.36', 'spread': '15.736', 'groupId': 'OG002'}, {'value': '31.67', 'spread': '24.194', 'groupId': 'OG003'}, {'value': '18.48', 'spread': '13.938', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 (n=3,8,14,3,18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.33', 'spread': '14.154', 'groupId': 'OG000'}, {'value': '13.13', 'spread': '9.538', 'groupId': 'OG001'}, {'value': '15.36', 'spread': '17.095', 'groupId': 'OG002'}, {'value': '33.67', 'spread': '25.007', 'groupId': 'OG003'}, {'value': '21.22', 'spread': '12.735', 'groupId': 'OG004'}]}]}, {'title': 'Week 96 (n=4,8,14,3,18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.25', 'spread': '9.215', 'groupId': 'OG000'}, {'value': '8.88', 'spread': '4.643', 'groupId': 'OG001'}, {'value': '13.07', 'spread': '15.711', 'groupId': 'OG002'}, {'value': '36.00', 'spread': '23.065', 'groupId': 'OG003'}, {'value': '21.56', 'spread': '13.984', 'groupId': 'OG004'}]}]}, {'title': 'Week 144 (n=2,6,10,3,2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.50', 'spread': '6.364', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '4.550', 'groupId': 'OG001'}, {'value': '18.80', 'spread': '18.760', 'groupId': 'OG002'}, {'value': '39.67', 'spread': '22.679', 'groupId': 'OG003'}, {'value': '26.00', 'spread': '26.870', 'groupId': 'OG004'}]}]}, {'title': 'Week 192 (n=2,3,7,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.414', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '1.414', 'groupId': 'OG001'}, {'value': '13.00', 'spread': '9.220', 'groupId': 'OG002'}]}]}, {'title': 'Week 240 (n=2,1,2,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.50', 'spread': '2.121', 'groupId': 'OG000'}, {'value': '9.00', 'groupId': 'OG001'}, {'value': '5.50', 'spread': '3.536', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 240', 'description': 'Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nMin and max possible scores are 0-100 respectively. 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'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '44.3', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '13.15', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '12.76', 'groupId': 'OG002'}, {'value': '21.0', 'spread': '22.52', 'groupId': 'OG003'}, {'value': '12.5', 'spread': '5.87', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 (n=2,9,14,2,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '15.08', 'groupId': 'OG001'}, {'value': '22.0', 'spread': '11.73', 'groupId': 'OG002'}, {'value': '16.5', 'spread': '7.78', 'groupId': 'OG003'}, {'value': '15.0', 'spread': '7.77', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 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'13.33', 'groupId': 'OG002'}, {'value': '17.0', 'groupId': 'OG003'}, {'value': '17.0', 'spread': '4.86', 'groupId': 'OG004'}]}]}, {'title': 'Week 144 (n=1,5,8,2,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '16.93', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '15.82', 'groupId': 'OG002'}, {'value': '17.0', 'spread': '9.90', 'groupId': 'OG003'}]}]}, {'title': 'Week 192 (1,2,7,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '22.63', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '18.12', 'groupId': 'OG002'}]}]}, {'title': 'Week 240 (1,1,2,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '33.0', 'spread': '16.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry', 'unitOfMeasure': 'MP Number of Scotomatous Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'title': 'Week 12 (n=2,9,11,1,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '13.92', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '8.69', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '5.5', 'spread': '7.11', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 (n=3,9,10,3,11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '17.00', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '9.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '11.3', 'spread': '8.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 (n=2,9,14,2,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '7.64', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '23.45', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '6.19', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 (n=1,8,13,2,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '25.31', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '5.66', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '8.52', 'groupId': 'OG004'}]}]}, {'title': 'Week 96 (n=2,8,13,1,7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '9.65', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '9.06', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '7.6', 'spread': '11.07', 'groupId': 'OG004'}]}]}, {'title': 'Week 144 (n=1,5,8,2,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '8.11', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '9.19', 'groupId': 'OG003'}]}]}, {'title': 'Week 192 (1,2,7,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '5.38', 'groupId': 'OG002'}]}]}, {'title': 'Week 240 (1,1,2,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry', 'unitOfMeasure': 'MP Percent Fixation Loss (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'title': 'Week 5 (n=6,10,13,3,20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.045', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.147', 'groupId': 'OG003'}, {'value': '0.08', 'spread': '0.064', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 (n=6,10,10,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.037', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.061', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '0.223', 'groupId': 'OG003'}, {'value': '0.15', 'spread': '0.096', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 (n=6,10,13,3,19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '0.109', 'groupId': 'OG002'}, {'value': '0.37', 'spread': '0.296', 'groupId': 'OG003'}, {'value': '0.22', 'spread': '0.111', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 (n=5,5,15,3,19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.098', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.101', 'groupId': 'OG002'}, {'value': '0.40', 'spread': '0.310', 'groupId': 'OG003'}, {'value': '0.29', 'spread': '0.130', 'groupId': 'OG004'}]}]}, {'title': 'Week 48 (n=5,9,13,3,21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.118', 'groupId': 'OG002'}, {'value': '0.48', 'spread': '0.384', 'groupId': 'OG003'}, {'value': '0.35', 'spread': '0.155', 'groupId': 'OG004'}]}]}, {'title': 'Week 72 (n=3,8,14,3,17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.374', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.214', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '0.425', 'groupId': 'OG003'}, {'value': '0.50', 'spread': '0.247', 'groupId': 'OG004'}]}]}, {'title': 'Week 96 (n=4,8,13,2,18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.246', 'groupId': 'OG002'}, {'value': '0.70', 'spread': '0.822', 'groupId': 'OG003'}, {'value': '0.60', 'spread': '0.282', 'groupId': 'OG004'}]}]}, {'title': 'Week 144 (n=2,6,8,3,2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.329', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '0.790', 'groupId': 'OG003'}, {'value': '0.98', 'spread': '0.144', 'groupId': 'OG004'}]}]}, {'title': 'Week 192 (n=2,2,5,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.346', 'groupId': 'OG002'}]}]}, {'title': 'Week 240 (n=2,0,2,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.007', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 240', 'description': 'Change from baseline in GA size as assessed by fundus autofluorescence', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for patients with a valid measurement without a protocol deviation with impact'}, {'type': 'SECONDARY', 'title': 'Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'Orbit devices', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total US Patients', 'description': 'Total US Patients'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.\n\nThe rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used.\n\nThis endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts.\n\nThe delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.', 'unitOfMeasure': 'percent of devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Orbit devices', 'denomUnitsSelected': 'Orbit devices', 'populationDescription': 'All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted.\n\n34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted.\n\nThe arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.'}, {'type': 'SECONDARY', 'title': 'Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'Orbit devices', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total US Patients', 'description': 'Total US Patients'}], 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.\n\nThe rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used.\n\nThis endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts.\n\nThe delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.', 'unitOfMeasure': 'percent of devices', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Orbit devices', 'denomUnitsSelected': 'Orbit devices', 'populationDescription': 'All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted.\n\n34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted.\n\nThe arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.'}, {'type': 'SECONDARY', 'title': 'Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'title': 'Subjects with at least one TEAE Related to Surgical Procedure', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctival haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': '-Cataract', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Retinal pigmentation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': '-Retinal haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '-Anterior chamber cell', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '-Conjunctival hyperaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '-Retinal tear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '-Vitreous floaters', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Choroidal haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Choroidal neovascularisation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Corneal oedema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Dry eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Eye discharge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Eye pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Eye pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Foreign body sensation in eyes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Iridocyclitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Keratitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Ocular discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Periorbital oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '-Corneal abrasion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Post procedural discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Procedural pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '-Suture related complication', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '-Intraocular pressure increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}, {'type': 'SECONDARY', 'title': 'Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}, {'type': 'SECONDARY', 'title': 'Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}, {'type': 'SECONDARY', 'title': 'Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'OG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'OG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'OG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'OG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - All treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'FG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'FG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'FG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'FG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'Initially Randomized to Receive PPY988 With the Transvitreal Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received PPY988 With the Transvitreal Procedure, After the Orbit-SDS Was Attempted Unsuccessfully', 'comment': 'Received PPY988 with the Transvitreal Procedure, after the Orbit Subretinal Delivery System was attempted unsuccessfully (regardless if completed or disc early)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Initially Randomized to Receive PPY988 With the Orbit Subretinal Delivery System', 'comment': 'Initially randomized to receive PPY988 with the Orbit Subretinal Delivery System (regardless if successful or unsuccessful)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'Initially Randomized to Receive PPY988 With the Orbit Subretinal Delivery System', 'comment': 'Initially randomized to receive PPY988 with the Orbit Subretinal Delivery System but the delivery was unsuccessful', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received PPY988 With the Transvitreal Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received PPY988 With the Orbit Subretinal Delivery System', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'switched to the GT005 2E10 vg via Transvitreal Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'GT005 2E10 vg Via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure'}, {'id': 'BG001', 'title': 'GT005 5E10 vg Via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure'}, {'id': 'BG002', 'title': 'GT005 2E11 vg Via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure'}, {'id': 'BG003', 'title': 'GT005 5E10 vg With Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System'}, {'id': 'BG004', 'title': 'GT005 2E11 vg With Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'spread': '8.21', 'groupId': 'BG000'}, {'value': '79.0', 'spread': '5.12', 'groupId': 'BG001'}, {'value': '80.5', 'spread': '4.02', 'groupId': 'BG002'}, {'value': '75.7', 'spread': '4.73', 'groupId': 'BG003'}, {'value': '77.3', 'spread': '6.60', 'groupId': 'BG004'}, {'value': '78.9', 'spread': '5.93', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-15', 'size': 3149462, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-07T16:27', 'hasProtocol': True}, {'date': '2024-06-17', 'size': 2032693, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-07T16:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A dose escalation study of the safety and efficacy of a single subretinal injection of GT005 in subjects with Macular Atrophy due to AMD'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2019-02-13', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2019-02-15', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-07', 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye', 'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.'}, {'measure': 'Summary of Non-Ocular Treatment Emergent Adverse Events', 'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.'}, {'measure': 'Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred', 'timeFrame': 'Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye', 'timeFrame': 'Up to Week 240', 'description': 'Best corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye', 'timeFrame': 'Up to Week 240', 'description': 'Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry.\n\nMesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 63 Area.'}, {'measure': 'Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry.\n\nMesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 95 Area.'}, {'measure': 'Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry'}, {'measure': 'Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry'}, {'measure': 'Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)', 'timeFrame': 'Up to Week 240', 'description': 'Macular sensitivity as assessed by mesopic Microperimetry'}, {'measure': 'Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye', 'timeFrame': 'Up to Week 240', 'description': 'Change from baseline in GA size as assessed by fundus autofluorescence'}, {'measure': 'Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device', 'timeFrame': 'Day 1', 'description': 'The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.\n\nThe rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used.\n\nThis endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts.\n\nThe delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.'}, {'measure': 'Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device', 'timeFrame': 'Day 1', 'description': 'The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.\n\nThe rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used.\n\nThis endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts.\n\nThe delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.'}, {'measure': 'Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.'}, {'measure': 'Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.'}, {'measure': 'Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.'}, {'measure': 'Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure', 'timeFrame': 'Day 1', 'description': 'Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.\n\nAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dry Age-related Macular Degeneration (Dry AMD)', 'AMD', 'Atrophic AMD', 'Geographic Atrophy (GA)', 'Dry-AMD', 'Dry AMD'], 'conditions': ['Dry Age-related Macular Degeneration', 'Macular Degeneration', 'Retinal Disease', 'Eye Diseases', 'Retinal Degeneration', 'Geographic Atrophy', 'Macular Atrophy']}, 'referencesModule': {'references': [{'pmid': '33750925', 'type': 'DERIVED', 'citation': 'Dreismann AK, McClements ME, Barnard AR, Orhan E, Hughes JP, Lachmann PJ, MacLaren RE. Functional expression of complement factor I following AAV-mediated gene delivery in the retina of mice and human cells. Gene Ther. 2021 May;28(5):265-276. doi: 10.1038/s41434-021-00239-9. Epub 2021 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).', 'detailedDescription': 'This was an open label first-in-human Phase I/II multicenter study to evaluate the safety, dose response and efficacy of GT005 in participants with Geographic atrophy (GA) due to Age-related macular degeneration (AMD).\n\nThe study treatment GT005 consists of an Adeno-associated virus serotype 2 (AAV2) expressing human complement factor I (hCFI). The treatment was administered as a single subretinal administration in one eye - the "study eye". Both eyes were assessed at the screening visit. If both eyes meet the eligibility criteria, the study eye will be the worse seeing eye, or the eye with the largest geographic atrophy (GA) lesion area for eyes with equivalent visual acuity, unless the participant (in consultation with the surgeon) expresses an alternative preference.\n\nThe study was conducted in 4 parts: in Part 1 and Part 2 GT005 was administered subretinally via transvitreal procedure; in Part 3 and 4 GT005 was delivered subretinally via a suprachoroidal cannulation with the Orbit Subretinal delivery system (SDS). The Orbit SDS is a 510(k) cleared device in the US, whereby Parts 3 and 4 were only conducted at US sites. The treatment consisted in 3 dose levels: low dose, 2E10 vector genomes (vg); medium dose, 5E10 vg; and high dose, 2E11 vg.\n\nThe study consisted of up to 13 visits over a 5-year period. All participants were assessed for the occurrence of treatment emergent adverse events (AE)s at each visit and underwent visual function and retinal imaging assessments and biological sampling as per the schedule of assessments.\n\nThis study was conducted in compliance with Independent ethics committees (IECs) / Institutional review boards (IRBs), informed consent regulations, the Declaration of Helsinki, nternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and the Food and Drug Administration (FDA) guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to give consent to study participation\n2. Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye (except if the subject is monocular)\n3. Cohorts 1 to 6: GA lesion(s) total size in the study eye must be ≥1.25mm2 and ≤17.5mm2.\n\n Cohort 7: GA lesion(s) total size in the study eye must be ≥1.25mm2\n4. GA lesion(s) in the study eye must reside completely within the FAF fundus image\n5. Cohorts 1 to 3: BCVA of ≤50 letters (6/36 Snellen acuity equivalent or worse) using ETDRS charts in the study eye Cohorts 4 to 7: BCVA of ≥24 letters (6/95 and 20/320 Snellen acuity equivalent or better) using ETDRS charts in the study eye\n6. Aged ≥55 years\n7. Able to attend all study visits and complete the study procedures\n8. Women of child-bearing potential need to have a negative urine pregnancy test within two weeks prior to receiving the drug. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy)\n\nExclusion Criteria:\n\n1. Have evidence or history of Choroidal Neovascularisation (CNV) in the study eye. Subjects are permitted to have CNV in the fellow eye defined as either:\n\n 1. Non-exudative/sub-clinical fellow eye CNV identified at screening, or\n 2. Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to screening\n2. Presence of moderate/severe non-proliferative diabetic retinopathy or worse in the study eye\n3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye\n4. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminum garnet capsulotomy is permitted if performed \\>10 weeks prior to Visit 1\n5. Have clinically significant cataract that may require surgery during the study period in the study eye\n6. Presence of moderate to severe glaucomatous optic neuropathy in the study eye; uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve surgery is also excluded\n7. Axial myopia of greater than -8 diopters in the study eye\n8. Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the Age-Related Eye Disease Study (AREDS) formula\n9. Have received a gene or cell therapy at any time\n10. Have a contraindication to the specified protocol corticosteroid regimen\n11. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant\n12. Active malignancy within the past 12 months, except for: Appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥12 months\n13. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study\n14. Cohorts 5 to 7 only: presence of metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, and other implanted electrodes or stimulators'}, 'identificationModule': {'nctId': 'NCT03846193', 'briefTitle': 'FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gyroscope Therapeutics Limited'}, 'officialTitle': 'FOCUS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD', 'orgStudyIdInfo': {'id': 'GT005-01'}, 'secondaryIdInfos': [{'id': 'CPPY988A12101', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GT005 2E10 vg via Transvitreal Procedure', 'description': 'GT005 2E10 vg via Transvitreal Procedure', 'interventionNames': ['Biological: GT005']}, {'type': 'EXPERIMENTAL', 'label': 'GT005 5E10 vg via Transvitreal Procedure', 'description': 'GT005 5E10 vg via Transvitreal Procedure', 'interventionNames': ['Biological: GT005']}, {'type': 'EXPERIMENTAL', 'label': 'GT005 2E11 vg via Transvitreal Procedure', 'description': 'GT005 2E11 vg via Transvitreal Procedure', 'interventionNames': ['Biological: GT005']}, {'type': 'EXPERIMENTAL', 'label': 'GT005 5E10 vg with Orbit Subretinal Delivery System', 'description': 'GT005 5E10 vg with Orbit Subretinal Delivery System', 'interventionNames': ['Device: GT005 / Device: Orbit™ Subretinal Delivery System']}, {'type': 'EXPERIMENTAL', 'label': 'GT005 2E11 vg with Orbit Subretinal Delivery System', 'description': 'GT005 2E11 vg with Orbit Subretinal Delivery System', 'interventionNames': ['Device: GT005 / Device: Orbit™ Subretinal Delivery System']}], 'interventions': [{'name': 'GT005', 'type': 'BIOLOGICAL', 'description': 'GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI). GT005 was administered as a single time subretinal injection into the study eye of subjects allocated to one of the two GT005 doses.', 'armGroupLabels': ['GT005 2E10 vg via Transvitreal Procedure', 'GT005 2E11 vg via Transvitreal Procedure', 'GT005 5E10 vg via Transvitreal Procedure']}, {'name': 'GT005 / Device: Orbit™ Subretinal Delivery System', 'type': 'DEVICE', 'description': 'GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI).\n\nA single dose of GT005 was administered with subretinal injection via suprachoroidal cannulation approach.\n\nDevice: Orbit™ Subretinal Delivery System', 'armGroupLabels': ['GT005 2E11 vg with Orbit Subretinal Delivery System', 'GT005 5E10 vg with Orbit Subretinal Delivery System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Wolfe Eye Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalamic Consultants of Boston (OCB)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pepose Vision Institute', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid-Atlantic Retina', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Eye Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'W1G 7LA', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Retina Clinic London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Moorfields Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Eye Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'Sunderland Eye Infirmary', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/', 'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gyroscope Therapeutics Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}