Viewing Study NCT02348359

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Ignite Creation Date: 2025-12-24 @ 2:35 PM
Ignite Modification Date: 2026-01-07 @ 6:40 PM
Study NCT ID: NCT02348359
Status: TERMINATED
Last Update Posted: 2022-02-11
First Post: 2015-01-21
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: X-82 to Treat Age-related Macular Degeneration
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'C566935', 'term': 'Macular Degeneration, Age-Related, 10'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}, {'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@Tyrogenex.com', 'phone': '240-403-7153', 'title': 'Vice President, Clinical and Regulatory', 'organization': 'Brace Pharma Capital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months', 'eventGroups': [{'id': 'EG000', 'title': '50 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 39, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': '100 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 38, 'seriousNumAtRisk': 39, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': '200 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 37, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nAnti-VEGF\n\nPlacebo', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 34, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Supraventricular systole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Conjunctival hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Retinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Neovascular age related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Eyelash discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Metamorphopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Bllod creatinine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Hepatic enzyme increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Urine protein/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 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0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Visual Acuity Score From Day -1 to Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg of X-82 Plus Ivt 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Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'OG001', 'title': '100 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'OG002', 'title': '200 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'OG003', 'title': 'Placebo Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nAnti-VEGF\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '5.58', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '10.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.', 'unitOfMeasure': 'number of letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis restricted to subjects who completed 52 weeks of treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'FG001', 'title': '100 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'FG002', 'title': '200 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'FG003', 'title': 'Placebo Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nAnti-VEGF\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'This study was conducted at 39 sites in the United States. There were 36 sites that screened subjects and 3 sites that did not screen any subjects. A total of 157 subjects were randomly assigned and treated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '50 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'BG001', 'title': '100 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'BG002', 'title': '200 mg of X-82 Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nX-82\n\nAnti-VEGF'}, {'id': 'BG003', 'title': 'Placebo Plus Ivt Anti-VEGF Prn', 'description': 'Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.\n\nAnti-VEGF\n\nPlacebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'spread': '8.23', 'groupId': 'BG000'}, {'value': '73.5', 'spread': '8.33', 'groupId': 'BG001'}, {'value': '75.0', 'spread': '7.63', 'groupId': 'BG002'}, {'value': '75.9', 'spread': '7.65', 'groupId': 'BG003'}, {'value': '75.0', 'spread': '7.95', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Best corrected visual acuity', 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '9.41', 'groupId': 'BG000'}, {'value': '71.2', 'spread': '12.17', 'groupId': 'BG001'}, {'value': '71.9', 'spread': '13.17', 'groupId': 'BG002'}, {'value': '68.8', 'spread': '12.43', 'groupId': 'BG003'}, {'value': '71.0', 'spread': '11.83', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of letters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized subjects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-12', 'size': 8863180, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-25T14:15', 'hasProtocol': True}, {'date': '2017-09-11', 'size': 514660, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-30T12:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'whyStopped': 'Interim analysis found study had achieved primary objective', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2015-01-21', 'resultsFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-30', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Visual Acuity Score From Day -1 to Week52', 'timeFrame': 'Week 52', 'description': 'The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vascular Endothelial Growth Factor (VEGF)', 'Platelet Derived Growth Factor (PDGF)', 'AMD'], 'conditions': ['Age-Related Macular Degeneration (AMD)', 'Macular Degeneration', 'Exudative Age-related Macular Degeneration', 'AMD', 'Macular Degeneration, Age-related, 10', 'Eye Diseases', 'Retinal Degeneration', 'Retinal Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.', 'detailedDescription': 'Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:\n\n* X-82 50 mg plus ivt anti-VEGF prn\n* X-82 100 mg plus ivt anti-VEGF prn\n* X-82 200 mg plus ivt anti-VEGF prn\n* Placebo plus ivt anti-VEGF prn\n\nSubjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.\n\nPrimary Efficacy Outcome:\n\nThe primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.\n\nSafety Outcomes:\n\nSystemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.\n\nApproximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.\n* Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1\n* Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes\n\nExclusion Criteria:\n\n* Previous vitrectomy to the study eye within 30 days of Screening Visit 1\n* Choroidal neovascularization (CNV) due to causes other than AMD\n* Proliferative diabetic retinopathy in either eye'}, 'identificationModule': {'nctId': 'NCT02348359', 'briefTitle': 'X-82 to Treat Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tyrogenex'}, 'officialTitle': 'A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD', 'orgStudyIdInfo': {'id': 'X82-OPH-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mg of X-82 plus ivt anti-VEGF prn', 'description': 'Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.', 'interventionNames': ['Drug: X-82', 'Drug: Anti-VEGF']}, {'type': 'EXPERIMENTAL', 'label': '100 mg of X-82 plus ivt anti-VEGF prn', 'description': 'Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.', 'interventionNames': ['Drug: X-82', 'Drug: Anti-VEGF']}, {'type': 'EXPERIMENTAL', 'label': '200 mg of X-82 plus ivt anti-VEGF prn', 'description': 'Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.', 'interventionNames': ['Drug: X-82', 'Drug: Anti-VEGF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus ivt anti-VEGF prn', 'description': 'Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.', 'interventionNames': ['Drug: Anti-VEGF', 'Drug: Placebo']}], 'interventions': [{'name': 'X-82', 'type': 'DRUG', 'otherNames': ['X-82 tablets'], 'armGroupLabels': ['100 mg of X-82 plus ivt anti-VEGF prn', '200 mg of X-82 plus ivt anti-VEGF prn', '50 mg of X-82 plus ivt anti-VEGF prn']}, {'name': 'Anti-VEGF', 'type': 'DRUG', 'otherNames': ['Aflibercept (Eylea)', 'Ranibizumab (Lucentis)', 'Bevacizumab (Avastin)'], 'armGroupLabels': ['100 mg of X-82 plus ivt anti-VEGF prn', '200 mg of X-82 plus ivt anti-VEGF prn', '50 mg of X-82 plus ivt anti-VEGF prn', 'Placebo plus ivt anti-VEGF prn']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo plus ivt anti-VEGF prn']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'city': 'Redlands', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'city': 'Bloomfield', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.80677, 'lon': -74.18542}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Daniel E Salazar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study PI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tyrogenex', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SynteractHCR', 'class': 'INDUSTRY'}, {'name': 'International Drug Development Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}