Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-11 @ 9:02 PM
Study NCT ID:
NCT02348918
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712274', 'term': 'risuteganib'}, {'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@allegroeye.com', 'phone': '949-940-8130', 'title': 'Director of Clinical Research', 'organization': 'Allegro Ophthalmics, LLC'}, 'certainAgreement': {'otherDetails': "Investigator will submit to Sponsor a copy of the proposed publication or presentation and the name of the scientific journal or forum to which it will be submitted- at least ninety (90) days prior to the submission.Investigator shall comply with Sponsor's request to delete references to Confidential Information,in any such paper or presentation and agrees to withhold publication or presentation of same for an additional ninety (90) days in order to permit Sponsor to obtain patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Luminate 1.0mg Group', 'description': 'Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 1.0mg', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 28, 'seriousNumAtRisk': 39, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Luminate 2.0mg Group', 'description': 'Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 2.0mg', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 20, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Luminate 3.0mg Group', 'description': 'Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 3.0mg', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 25, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Avastin® Group', 'description': 'Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.\n\nAvastin', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 16, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Avastin Then Luminate 1.0 mg IVT + Sham Injection', 'description': 'Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 10, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Avastin Then Luminate 0.5 mg IVT + Sham Injection', 'description': 'Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Avastin 1.25 mg + Sham IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN\n\nLuminate 0.5mg', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Blood and Lymphatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Metabolism and nutritional disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'musculoskeletal and connective tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Metabolism and nutritional disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neoplasms benign malignant and unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Respitatory, thoracic and mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in BCVA at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Luminate 1.0mg Group', 'description': 'Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 1.0mg'}, {'id': 'OG001', 'title': 'Luminate 2.0mg Group', 'description': 'Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 2.0mg'}, {'id': 'OG002', 'title': 'Luminate 3.0mg Group', 'description': 'Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 3.0mg'}, {'id': 'OG003', 'title': 'Avastin® Group', 'description': 'Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.\n\nAvastin'}, {'id': 'OG004', 'title': 'Avastin Then Luminate 1.0 mg IVT + Sham Injection', 'description': 'Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin'}, {'id': 'OG005', 'title': 'Avastin Then Luminate 0.5 mg IVT + Sham Injection', 'description': 'Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg'}, {'id': 'OG006', 'title': 'Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin'}, {'id': 'OG007', 'title': 'Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg'}, {'id': 'OG008', 'title': 'Avastin 1.25 mg + Sham IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN\n\nLuminate 0.5mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '3', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '3', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '3', 'groupId': 'OG002'}, {'value': '7', 'spread': '3', 'groupId': 'OG003'}, {'value': '7.1', 'spread': '3', 'groupId': 'OG004'}, {'value': '4.6', 'spread': '3', 'groupId': 'OG005'}, {'value': '1.4', 'spread': '3', 'groupId': 'OG006'}, {'value': '3.9', 'spread': '3', 'groupId': 'OG007'}, {'value': '6.7', 'spread': '3', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Value of 24 Weeks minus baseline value', 'description': 'Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline', 'unitOfMeasure': 'Letters on ETDRS eye chart', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Luminate 1.0mg Group', 'description': 'Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 1.0mg'}, {'id': 'FG001', 'title': 'Luminate 2.0mg Group', 'description': 'Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 2.0mg'}, {'id': 'FG002', 'title': 'Luminate 3.0mg Group', 'description': 'Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 3.0mg'}, {'id': 'FG003', 'title': 'Avastin® Group', 'description': 'Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.\n\nAvastin'}, {'id': 'FG004', 'title': 'Avastin Then Luminate 1.0 mg IVT + Sham Injection', 'description': 'Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin'}, {'id': 'FG005', 'title': 'Avastin Then Luminate 0.5 mg IVT + Sham Injection', 'description': 'Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg'}, {'id': 'FG006', 'title': 'Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin'}, {'id': 'FG007', 'title': 'Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg'}, {'id': 'FG008', 'title': 'Avastin 1.25 mg + Sham IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN\n\nLuminate 0.5mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '218', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Luminate 1.0mg Group', 'description': 'Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 1.0mg'}, {'id': 'BG001', 'title': 'Luminate 2.0mg Group', 'description': 'Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 2.0mg'}, {'id': 'BG002', 'title': 'Luminate 3.0mg Group', 'description': 'Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.\n\nLuminate 3.0mg'}, {'id': 'BG003', 'title': 'Avastin® Group', 'description': 'Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.\n\nAvastin'}, {'id': 'BG004', 'title': 'Avastin Then Luminate 1.0 mg IVT + Sham Injection', 'description': 'Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin'}, {'id': 'BG005', 'title': 'Avastin Then Luminate 0.5 mg IVT + Sham Injection', 'description': 'Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg'}, {'id': 'BG006', 'title': 'Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nLuminate 1.0mg\n\nAvastin'}, {'id': 'BG007', 'title': 'Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT\n\nAvastin\n\nLuminate 0.5mg'}, {'id': 'BG008', 'title': 'Avastin 1.25 mg + Sham IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN\n\nLuminate 0.5mg'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '135', 'groupId': 'BG009'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '83', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '9.05', 'groupId': 'BG000'}, {'value': '61', 'spread': '9.91', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '9.45', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '8.83', 'groupId': 'BG003'}, {'value': '67.1', 'spread': '10.47', 'groupId': 'BG004'}, {'value': '65.5', 'spread': '9.41', 'groupId': 'BG005'}, {'value': '60.1', 'spread': '10.92', 'groupId': 'BG006'}, {'value': '60.5', 'spread': '8.29', 'groupId': 'BG007'}, {'value': '62.1', 'spread': '9.35', 'groupId': 'BG008'}, {'value': '62.3', 'spread': '9.35', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '106', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '112', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'white', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}, {'value': '181', 'groupId': 'BG009'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '218', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-07', 'size': 1608969, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-02T13:26', 'hasProtocol': True}, {'date': '2017-03-17', 'size': 511641, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-02T13:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2015-01-12', 'resultsFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-05', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BCVA at Week 24', 'timeFrame': 'Value of 24 Weeks minus baseline value', 'description': 'Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema', 'detailedDescription': 'To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema\n\n\\- Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).\n\nStage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 years of age or older.\n* Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT\n* Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.\n* Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.\n* In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.\n* Intra-Ocular Pressure (IOP) is under control (i.e., IOP\n\n ≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.\n* Willing and able to return for all study visits.\n* Able to meet the extensive post-op evaluation regimen.\n* Understands and signs the informed consent form.\n\nExclusion Criteria:\n\n* Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.\n* Uncontrolled hypertension defined as systolic \\>180 mmHg or \\> 160 mmHg on 2 consecutive measurements or diastolic \\> 100 mmHg on optimal medical regimen\n* Screening HgA1c blood test \\> 10.0\n* Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.\n* A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.\n* History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.\n* Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.\n* Previous pars plana vitrectomy in the study eye\n* Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.\n* YAG laser treatment in the study eye in last 30 days prior to study enrollment.\n* High myopia in the study eye, with a spherical equivalent of \\>8.00D at screening\n* Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.\n* Chronic or recurrent uveitis.\n* Ongoing ocular infection or inflammation in either eye.\n* A history of cataract surgery complications/vitreous loss in the study eye.\n* Congenital eye malformations in the study eye.\n* A history of penetrating ocular trauma in the study eye.\n* Mentally handicapped.\n* Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.\n* Nursing female.\n* Currently participating in any other clinical research study.\n* Contraindication to the study medication."}, 'identificationModule': {'nctId': 'NCT02348918', 'briefTitle': 'Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allegro Ophthalmics, LLC'}, 'officialTitle': 'A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® in the Treatment of Diabetic Macular Edema (DME)', 'orgStudyIdInfo': {'id': 'DME 202B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Luminate 1.0mg group', 'description': 'Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.', 'interventionNames': ['Drug: Luminate 1.0mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Luminate 2.0mg group', 'description': 'Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.', 'interventionNames': ['Drug: Luminate 2.0mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Luminate 3.0mg group', 'description': 'Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.', 'interventionNames': ['Drug: Luminate 3.0mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin® group', 'description': 'Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.', 'interventionNames': ['Drug: Avastin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin then Luminate 1.0 mg IVT + sham injection', 'description': 'Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT', 'interventionNames': ['Drug: Luminate 1.0mg', 'Drug: Avastin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin then Luminate 0.5 mg IVT + sham injection', 'description': 'Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT', 'interventionNames': ['Drug: Avastin', 'Drug: Luminate 0.5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT', 'interventionNames': ['Drug: Luminate 1.0mg', 'Drug: Avastin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT', 'description': 'Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT', 'interventionNames': ['Drug: Avastin', 'Drug: Luminate 0.5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin 1.25 mg + Sham IVT', 'description': 'Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN', 'interventionNames': ['Drug: Luminate 0.5mg']}], 'interventions': [{'name': 'Luminate 1.0mg', 'type': 'DRUG', 'otherNames': ['ALG-1001'], 'armGroupLabels': ['Avastin then Luminate 1.0 mg IVT + sham injection', 'Luminate 1.0mg group', 'Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT']}, {'name': 'Luminate 2.0mg', 'type': 'DRUG', 'otherNames': ['ALG-1001'], 'armGroupLabels': ['Luminate 2.0mg group']}, {'name': 'Luminate 3.0mg', 'type': 'DRUG', 'otherNames': ['ALG-1001'], 'armGroupLabels': ['Luminate 3.0mg group']}, {'name': 'Avastin', 'type': 'DRUG', 'otherNames': ['bevacizumab'], 'armGroupLabels': ['Avastin then Luminate 0.5 mg IVT + sham injection', 'Avastin then Luminate 1.0 mg IVT + sham injection', 'Avastin® group', 'Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT', 'Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT']}, {'name': 'Luminate 0.5mg', 'type': 'DRUG', 'otherNames': ['ALG-1001'], 'armGroupLabels': ['Avastin 1.25 mg + Sham IVT', 'Avastin then Luminate 0.5 mg IVT + sham injection', 'Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Retina', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Retina Medical Group', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Retina Associates', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Clinic', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Specialty Institute', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Retina and Macular Disease', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute at John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49202', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'facility': 'TLC Eye Group', 'geoPoint': {'lat': 42.24587, 'lon': -84.40135}}, {'zip': '11967', 'city': 'Shirley', 'state': 'New York', 'country': 'United States', 'facility': 'Island Retina', 'geoPoint': {'lat': 40.80149, 'lon': -72.8676}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte EENT Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Regional Eye Institute', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Retina Associates', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultant of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Eye Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Vicken Karageozian', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cheif Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allegro Ophthalmics, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Trial Runners, LLC', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}