Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-25 @ 2:43 AM
Study NCT ID:
NCT01969708
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
Sponsor:
Organization:
Raw JSON
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'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'score2@emmes.com', 'phone': '301-251-1161', 'title': 'Principal Investigator of the SCORE2 Data Coordinating Center', 'organization': 'The Emmes Corporation'}, 'certainAgreement': {'otherDetails': 'Trial results can not be discussed until they have been made available to the public.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Month 0 to 6', 'eventGroups': [{'id': 'EG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 82, 'seriousNumAtRisk': 180, 'deathsNumAffected': 1, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Bevacizumab', 'description': '1.25 mg 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'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 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increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General 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'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Endodontic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eyelid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 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'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Waldenstrom's macroglobulinaemia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'OG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '16.62', 'upperLimit': '21.15'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '16.16', 'upperLimit': '21.09'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 to 6', 'description': 'The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.', 'unitOfMeasure': 'letters read', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with visual acuity letter score recorded at Month 6'}, {'type': 'SECONDARY', 'title': 'Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'OG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6', 'unitOfMeasure': 'study eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with visual acuity letter score recorded at Month 6'}, {'type': 'SECONDARY', 'title': 'Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'OG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6', 'unitOfMeasure': 'study eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with visual acuity letter score recorded at Month 6'}, {'type': 'SECONDARY', 'title': 'Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'OG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '231.3', 'groupId': 'OG000', 'lowerLimit': '220.8', 'upperLimit': '241.8'}, {'value': '287.9', 'groupId': 'OG001', 'lowerLimit': '269.4', 'upperLimit': '306.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography', 'unitOfMeasure': 'um', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with central subfield thickness recorded at baseline and Month 6'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'OG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '-425', 'groupId': 'OG000', 'lowerLimit': '-461', 'upperLimit': '-389'}, {'value': '-387', 'groupId': 'OG001', 'lowerLimit': '-426', 'upperLimit': '-348'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness', 'unitOfMeasure': 'um', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with central subfield thickness recorded at baseline and Month 6'}, {'type': 'SECONDARY', 'title': 'Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'OG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the number of study eyes with central subfield thickness \\<300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6', 'unitOfMeasure': 'study eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with central subfield thickness recorded at Month 6'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'FG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab.', 'preAssignmentDetails': 'Participants were assigned to a treatment arm at enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aflibercept', 'description': '2.0 mg aflibercept every 4 weeks\n\naflibercept'}, {'id': 'BG001', 'title': 'Bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks\n\nbevacizumab'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Visual Acuity Letter Score (VALS) of Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.', 'unitOfMeasure': 'letters read', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time between diagnosis of macular edema and randomization', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '17', 'groupId': 'BG000'}, {'value': '5', 'spread': '10', 'groupId': 'BG001'}, {'value': '7', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spectral Domain-Optical Coherence Tomography (SD-OCT) central subfield thickness', 'classes': [{'categories': [{'measurements': [{'value': '652.4', 'spread': '214.6', 'groupId': 'BG000'}, {'value': '678.2', 'spread': '233.3', 'groupId': 'BG001'}, {'value': '665.5', 'spread': '224.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'um', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior anti-vascular endothelial growth factor (VEGF) treatment', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior intravitreal steroid use', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemiretinal vein occlusion', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cataract extraction', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of cataract', 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus type 1', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus type 2', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertensive', 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary artery disease', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25 overall score', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '15', 'groupId': 'BG000'}, {'value': '77', 'spread': '17', 'groupId': 'BG001'}, {'value': '77', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25, respondents answer a series of multiple-choice questions about their vision and how it affects daily life. The overall scores range from 0 to 100, with higher scores representing better functioning.', 'unitOfMeasure': 'total score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-11', 'studyFirstSubmitDate': '2013-10-22', 'resultsFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-23', 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6', 'timeFrame': 'Month 0 to 6', 'description': 'The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.'}], 'secondaryOutcomes': [{'measure': 'Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6'}, {'measure': 'Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6'}, {'measure': 'Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography'}, {'measure': 'Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness'}, {'measure': 'Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces', 'timeFrame': 'Month 0 to 6', 'description': 'The measure is the number of study eyes with central subfield thickness \\<300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Central Retinal Vein Occlusion']}, 'referencesModule': {'availIpds': [{'id': 'PB2016-103333', 'url': 'https://ntrl.ntis.gov/NTRL/', 'type': 'Study Protocol', 'comment': 'SCORE2 Protocol Version 3.0 (the Identifier for the appendices is PB2016-103334)'}], 'references': [{'pmid': '27450625', 'type': 'BACKGROUND', 'citation': 'Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Figueroa M; SCORE2 Investigator Group. SCORE2 Report 1: Techniques to Optimize Recruitment in Phase III Clinical Trials of Patients With Central Retinal Vein Occlusion. Am J Ophthalmol. 2016 Oct;170:25-31. doi: 10.1016/j.ajo.2016.07.011. Epub 2016 Jul 19.'}, {'pmid': '27863843', 'type': 'BACKGROUND', 'citation': 'Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Figueroa M, Dugel PU; SCORE2 Investigator Group. SCORE2 Report 2: Study Design and Baseline Characteristics. Ophthalmology. 2017 Feb;124(2):245-256. doi: 10.1016/j.ophtha.2016.09.038. Epub 2016 Nov 15.'}, {'pmid': '28492860', 'type': 'BACKGROUND', 'citation': 'Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, King J, Antoszyk AN, Peters MA, Tolentino M; SCORE2 Investigator Group. Baseline Factors Associated With 6-Month Visual Acuity and Retinal Thickness Outcomes in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Study Report 4. JAMA Ophthalmol. 2017 Jun 1;135(6):639-649. doi: 10.1001/jamaophthalmol.2017.1141.'}, {'pmid': '29074161', 'type': 'BACKGROUND', 'citation': 'Scott IU, Figueroa MJ, Oden NL, Ip MS, Blodi BA, VanVeldhuisen PC; SCORE2 Investigator Group. SCORE2 Report 5: Vision-Related Function in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion. Am J Ophthalmol. 2017 Dec;184:147-156. doi: 10.1016/j.ajo.2017.10.008. Epub 2017 Oct 23.'}, {'pmid': '29476687', 'type': 'BACKGROUND', 'citation': 'Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Altaweel M, Berinstein DM; SCORE2 Investigator Group. Comparison of Monthly vs Treat-and-Extend Regimens for Individuals With Macular Edema Who Respond Well to Anti-Vascular Endothelial Growth Factor Medications: Secondary Outcomes From the SCORE2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Apr 1;136(4):337-345. doi: 10.1001/jamaophthalmol.2017.6843.'}, {'pmid': '29746405', 'type': 'BACKGROUND', 'citation': 'Peterson JS, Rockwell K Jr, Scott IU, Ip MS, VanVeldhuisen PC, Blodi BA; SCORE2 Investigator Group. LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS. Retina. 2019 Sep;39(9):1802-1809. doi: 10.1097/IAE.0000000000002212.'}, {'pmid': '30589922', 'type': 'BACKGROUND', 'citation': 'Ip MS, Oden NL, Scott IU, VanVeldhuisen PC, Blodi BA, Ghuman T, Baker CW; SCORE2 Investigator Group. Month 12 Outcomes After Treatment Change at Month 6 Among Poor Responders to Aflibercept or Bevacizumab in Eyes With Macular Edema Secondary to Central or Hemiretinal Vein Occlusion: A Secondary Analysis of the SCORE2 Study. JAMA Ophthalmol. 2019 Mar 1;137(3):281-287. doi: 10.1001/jamaophthalmol.2018.6111.'}, {'pmid': '32353052', 'type': 'BACKGROUND', 'citation': 'Etheridge T, Dobson ETA, Wiedenmann M, Papudesu C, Scott IU, Ip MS, Eliceiri KW, Blodi BA, Domalpally A. A semi-automated machine-learning based workflow for ellipsoid zone analysis in eyes with macular edema: SCORE2 pilot study. PLoS One. 2020 Apr 30;15(4):e0232494. doi: 10.1371/journal.pone.0232494. eCollection 2020.'}, {'pmid': '32828880', 'type': 'BACKGROUND', 'citation': 'Hendrick A, VanVeldhuisen PC, Scott IU, King J, Blodi BA, Ip MS, Khurana RN, Oden NL; SCORE2 Investigator Group. SCORE2 Report 13: Intraretinal Hemorrhage Changes in Eyes With Central or Hemiretinal Vein Occlusion Managed With Aflibercept, Bevacizumab or Observation. Secondary Analysis of the SCORE and SCORE2 Clinical Trials. Am J Ophthalmol. 2021 Feb;222:185-193. doi: 10.1016/j.ajo.2020.08.030. Epub 2020 Aug 20.'}, {'pmid': '34003964', 'type': 'BACKGROUND', 'citation': 'Etheridge T, Dobson ETA, Wiedenmann M, Oden N, VanVeldhuisen P, Scott IU, Ip MS, Eliceiri KW, Blodi BA, Domalpally A. Ellipsoid Zone Defects in Retinal Vein Occlusion Correlates With Visual Acuity Prognosis: SCORE2 Report 14. Transl Vis Sci Technol. 2021 Mar 1;10(3):31. doi: 10.1167/tvst.10.3.31.'}, {'pmid': '33373715', 'type': 'BACKGROUND', 'citation': 'Etheridge T, Blodi B, Oden N, Van Veldhuisen P, Scott IU, Ip MS, Mititelu M, Domalpally A. Spectral Domain OCT Predictors of Visual Acuity in the Study of COmparative Treatments for REtinal Vein Occlusion 2: SCORE 2 Report 15. Ophthalmol Retina. 2021 Oct;5(10):991-998. doi: 10.1016/j.oret.2020.12.016. Epub 2020 Dec 26.'}, {'pmid': '28492910', 'type': 'RESULT', 'citation': 'Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Awh CC, Kunimoto DY, Marcus DM, Wroblewski JJ, King J; SCORE2 Investigator Group. Effect of Bevacizumab vs Aflibercept on Visual Acuity Among Patients With Macular Edema Due to Central Retinal Vein Occlusion: The SCORE2 Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2072-2087. doi: 10.1001/jama.2017.4568.'}, {'pmid': '37943541', 'type': 'DERIVED', 'citation': 'Aref AA, Scott IU, Oden NL, Ip MS, VanVeldhuisen PC, Blodi BA; SCORE and SCORE2 Study Investigator Groups. Intraocular Pressure in Eyes With Retinal Vein Occlusion Compared With Fellow Eyes: Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) Report 27. JAMA Ophthalmol. 2023 Dec 1;141(12):1172-1174. doi: 10.1001/jamaophthalmol.2023.5159.'}, {'pmid': '37220815', 'type': 'DERIVED', 'citation': 'Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA; SCORE2 Investigator Group. SCORE2 Report 24: Nonlinear Relationship of Retinal Thickness and Visual Acuity in Central Retinal and Hemiretinal Vein Occlusion. Ophthalmology. 2023 Oct;130(10):1066-1072. doi: 10.1016/j.ophtha.2023.05.023. Epub 2023 May 21.'}, {'pmid': '36584835', 'type': 'DERIVED', 'citation': 'Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA; SCORE2 Investigator Group. SCORE2 Report 20: Relationship of Treatment Discontinuation With Visual Acuity and Central Subfield Thickness Outcomes. Am J Ophthalmol. 2023 Apr;248:157-163. doi: 10.1016/j.ajo.2022.12.026. Epub 2022 Dec 28.'}, {'pmid': '35461831', 'type': 'DERIVED', 'citation': 'Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA; SCORE2 Investigator Group. Month 60 Outcomes After Treatment Initiation With Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion. Am J Ophthalmol. 2022 Aug;240:330-341. doi: 10.1016/j.ajo.2022.04.001. Epub 2022 Apr 21.'}, {'pmid': '34709363', 'type': 'DERIVED', 'citation': 'Aref AA, Scott IU, VanVeldhuisen PC, King J, Ip MS, Blodi BA, Oden NL; Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) Investigator Group. Intraocular Pressure-Related Events After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Report 16 on a Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Dec 1;139(12):1285-1291. doi: 10.1001/jamaophthalmol.2021.4395.'}, {'pmid': '33415354', 'type': 'DERIVED', 'citation': 'Khurana RN, Oden NL, VanVeldhuisen PC, Scott IU, Blodi BA, Ip MS; SCORE2 Investigator Group. Association between early and late response in eyes with central or hemiretinal vein occlusion treated with anti-VEGF agents : SCORE2 report 12: secondary analysis of the SCORE2 clinical trial. Graefes Arch Clin Exp Ophthalmol. 2021 Jul;259(7):1839-1851. doi: 10.1007/s00417-020-05018-7. Epub 2021 Jan 7.'}, {'pmid': '31600368', 'type': 'DERIVED', 'citation': 'Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA, Chan CK; SCORE2 Investigator Group. Month 24 Outcomes After Treatment Initiation With Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1389-1398. doi: 10.1001/jamaophthalmol.2019.3947.'}, {'pmid': '31169862', 'type': 'DERIVED', 'citation': 'Scott IU, VanVeldhuisen PC, Barton F, Oden NL, Ip MS, Blodi BA, Worrall M, Fish GE; Study of Comparative Treatments for Retinal Vein Occlusion 2 Investigator Group. Patient-Reported Visual Function Outcomes After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: Preplanned Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Aug 1;137(8):932-938. doi: 10.1001/jamaophthalmol.2019.1519.'}]}, 'descriptionModule': {'briefSummary': 'SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every 4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at Month 6.', 'detailedDescription': 'The primary objective of SCORE2 is to test for non-inferiority based on mean change from baseline in visual acuity letter score at Month 6 for eyes randomized to intravitreal bevacizumab every 4 weeks compared with eyes randomized to intravitreal aflibercept every 4 weeks using a non-inferiority margin of 5 letters.\n\nSecondary objectives of SCORE2 are to:\n\n* compare the bevacizumab and the aflibercept groups with regards to central retinal thickness, as measured with spectral domain optical coherence tomography (SD-OCT), at Month 6 and change between baseline and Month 6;\n* assess Month 12 visual acuity and SD-OCT outcomes associated with different dosing strategies after Month 6 in participants who respond well to treatment;\n* assess Month 12 visual acuity and SD-OCT outcomes associated with alternative treatment strategies after Month 6 in participants who respond poorly to treatment;\n* compare area of retinal ischemia and rates of neovascular complications of CRVO in the bevacizumab vs. aflibercept groups;\n* add to our knowledge of the safety profile of these anti-vascular endothelial growth factor (VEGF) medications in the setting of eyes with macular edema secondary to CRVO;\n* conduct a cost effectiveness analysis comparing intravitreal bevacizumab to intravitreal aflibercept to assess the economic implications from a payor perspective using decision analytic methods.\n\nOther exploratory aims of SCORE2 are to:\n\n* investigate the correlation of features identified through SD-OCT segmentation analysis, such as the inner segment-outer segment (IS-OS) junction (also known as the ellipsoid zone), with such characteristics as visual acuity and central retinal thickness;\n* investigate the correlation of area of peripheral retinal nonperfusion from widefield fluorescein angiography with visual acuity and central retinal thickness, and the prognostic value of baseline peripheral and central retina perfusion status in predicting disease course and treatment responsiveness;\n* investigate the correlation of features on adaptive optics imaging with such characteristics as visual acuity and central retinal thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have center-involved macular edema secondary to CRVO. Eyes may be enrolled as early as the time of diagnosis of the macular edema. The definition of CRVO used in SCORE will also be used for the purposes of SCORE2: a CRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g., telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in all 4 quadrants.\n* Due to the similarities of a hemiretinal vein occlusion (HRVO) to CRVO,HRVO will be classified as CRVO for the purposes of this clinical trial. Eyes classified as having a HRVO will be limited to no more than 25% of the planned sample size. A HRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in 5 or more clock hours but less than all 4 quadrants. Typically, a HRVO is a retinal vein occlusion that involves 2 altitudinal quadrants.\n* E-Early Treatment Diabetic Retinopathy Study (ETDRS)visual acuity score of greater than or equal to 19 letters (approximately 20/400) and less than or equal to 73 letters (approximately 20/40) by the ETDRS visual acuity protocol. The investigator must believe that a study eye with visual acuity between 19 and 33 letters is perfused.\n* Retinal thickness on SD-OCT measurement, defined as central subfield thickness of 300 µm or greater. If the SD-OCT measurement is taken from a Heidelberg Spectralis Machine, the central subfield thickness should be 320 µm or greater.\n* Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.\n\nExclusion Criteria:\n\n* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers indicating difficulty in long term follow-up, likelihood of survival of less than 12 months).\n* Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at time of study entry.\n* History of allergy to any anti-VEGF agent, corticosteroid, or component of the delivery vehicle.\n* The participant will be moving out of the area of the clinical site to an area not covered by another clinical site during the 12 months of the study.\n* Positive urine pregnancy test: all women of childbearing potential (those who are pre-menopausal and not surgically sterilized) may participate only if they have a negative urine pregnancy test, and if they do not intend to become pregnant during the timeframe of the study. Women who are sexually active with a male partner must agree to use at least one of the following birth control methods: hormonal therapy such as oral, implantable or injectable chemical contraceptives; mechanical therapy such as spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner.\n* Women who are breast-feeding.\n* Examination evidence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT thought to be contributing to macular edema.\n* An eye that, in the investigator's opinion, would not benefit from resolution of macular edema such as eyes with foveal atrophy, dense pigmentary changes or dense subfoveal hard exudates.\n* Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, iris neovascularization, Irvine-Gass Syndrome, prior macula-off rhegmatogenous retinal detachment).\n* Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract).\n* History of laser photocoagulation for macular edema within 3 months prior to randomization.\n* History of intravitreal corticosteroid within 4 months of randomization.\n* Intravitreal anti-VEGF injection within 2 months of randomization. Note: Enrollment will be limited to no more than 25% of the planned sample size with any history of anti-VEGF treatment. Once this number of eyes has been enrolled, any history of anti-VEGF treatment will be an exclusion criterion. For enrollment of study eyes with prior intravitreal anti-VEGF agents, in the opinion of the investigator, the treatment response to prior anti-VEGF treatment must be either incomplete or the study eye had developed recurrent CRVO-associated macular edema, such that the study eye would benefit from additional anti-VEGF treatment.\n* History of peribulbar or retrobulbar corticosteroid use for any reason within 2 months prior to randomization.\n* History of panretinal scatter photocoagulation (PRP) or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 3 months following randomization.\n* History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to randomization or anticipated within the next 6 months following randomization.\n* History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization.\n* Aphakia.\n* Presence of an anterior chamber intraocular lens\n* Examination evidence of external ocular infection, including conjunctivitis, chalazion or significant blepharitis.\n* History of macular detachment.\n* Examination evidence of any diabetic retinopathy."}, 'identificationModule': {'nctId': 'NCT01969708', 'acronym': 'SCORE2', 'briefTitle': 'Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Emmes Company, LLC'}, 'officialTitle': 'Study of COmparative Treatments for REtinal Vein Occlusion 2 [SCORE2]: a Multicenter, Prospective, Randomized Non-inferiority Trial of Eyes With Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing Intravitreal Bevacizumab Every 4 Weeks With Intravitreal Aflibercept Every 4 Weeks.', 'orgStudyIdInfo': {'id': 'SCORE2'}, 'secondaryIdInfos': [{'id': 'U10EY023529', 'link': 'https://reporter.nih.gov/quickSearch/U10EY023529', 'type': 'NIH'}, {'id': 'U10EY023533', 'link': 'https://reporter.nih.gov/quickSearch/U10EY023533', 'type': 'NIH'}, {'id': 'U10EY023521', 'link': 'https://reporter.nih.gov/quickSearch/U10EY023521', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aflibercept', 'description': '2.0 mg aflibercept every 4 weeks', 'interventionNames': ['Drug: aflibercept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bevacizumab', 'description': '1.25 mg bevacizumab every 4 weeks', 'interventionNames': ['Drug: bevacizumab']}], 'interventions': [{'name': 'aflibercept', 'type': 'DRUG', 'otherNames': ['EYLEA'], 'armGroupLabels': ['aflibercept']}, {'name': 'bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'armGroupLabels': ['bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Consultants of AZ', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Centers, P.C.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Retina Consultants, Inc.', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92211', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Desert Retina Consultants', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis, Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group, Inc.', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Retina Associates', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Group of Florida', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Dept of Ophthalmology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Retina Consultants', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Retina Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'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': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Retina Consultants', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Retina, P.C.', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Eye and Ear Infirmary UIC Dept. of Ophthalmology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Thomas A. 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'country': 'United States', 'facility': 'Elman Retina Group, PA', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Retina Group of Washington', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Retina Group, P.A.', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cumberland Valley Retina Consultants', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Retina Group, P.A.', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 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'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Retina Northwest, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Casey Eye Institute / OHSU', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Retina Vitreous Consultants', 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29501', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolinas Centers for 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'79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Research Institute of Texas', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The Retina Research Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose & Throat Associates, P.A.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina & Vitreous of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Houston, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Retina Institute, PA', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Retinal Consultants of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Retina Group of Washington', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Ingrid U Scott, M.D., M.P.H.', 'role': 'STUDY_CHAIR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The time frame will be determined', 'ipdSharing': 'YES', 'description': 'SCORE2 will follow specific plans for sharing of research data. After analysis, the final data set can be provided after appropriate procedures are implemented to preserve the anonymity of the records, specifically where protected health information (PHI) is required. Upon request, anonymized data will be shared under confidentiality agreements with researchers interested in the project.', 'accessCriteria': 'Confidentiality agreements will be required before anonymized data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}