Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02634333
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anti-VEGF Treatment for Prevention of PDR/DME
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhuggins@jaeb.org', 'phone': '8139758690', 'title': 'Adam Glassman', 'organization': 'JAEB CENTER FOR HEALTH RESEARCH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 Years', 'description': 'To get the total number of participant/eyes in each treatment group add the unilateral and bilateral participants together:\n\nUnilateral Aflibercept = 129 Total aflibercept = unilateral aflibercept + bilateral = 129 + 71 = 200\n\nUnilateral sham = 128 total sham = unilateral sham + bilateral = 128 + 71 = 199', 'eventGroups': [{'id': 'EG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 116, 'seriousNumAtRisk': 129, 'deathsNumAffected': 9, 'seriousNumAffected': 52}, {'id': 'EG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 112, 'seriousNumAtRisk': 128, 'deathsNumAffected': 10, 'seriousNumAffected': 50}, {'id': 'EG002', 'title': 'Bilateral Participants', 'description': 'Participants with one eye enrolled in each arm of the study.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 62, 'seriousNumAtRisk': 71, 'deathsNumAffected': 5, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anemia, unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Macrocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bundle branch block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fluid in middle ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Inner ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diabetes mellitus poor control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': "Graves' disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of control of blood sugar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thyroid nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Worsening of diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abnormal vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anatomical narrow angle borderline glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anterior chamber angle neovascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anterior membrane dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrophy of macula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blepharitis (eyelid irritation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blepharo conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Burning eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 26, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cataract cortical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Peripheral arterial disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stroke (cerebrovascular accident)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stroke - Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Development of PDR and/or DME (Whichever Came First)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Units are in eyes. A participant could have 2 study eyes. For participants with two study eyes the participant was randomly assigned to receive sham in the eye with worse diabetic retinopathy and aflibercept in the other, or aflibercept in the eye with the worse diabetic retinopathy and sham in the other.'}, {'type': 'PRIMARY', 'title': 'Change in Visual Acuity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.', 'unitOfMeasure': 'Letter Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Change in Visual Acuity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 years', 'description': 'Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.', 'unitOfMeasure': 'Letter Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Includes only eyes that completed the 4-year visit.'}, {'type': 'SECONDARY', 'title': 'Development of PDR and/or DME (Whichever Came First)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Units are in eyes. A participant could have 2 study eyes. For participants with two study eyes the participant was randomly assigned to receive sham in the eye with worse diabetic retinopathy and aflibercept in the other, or aflibercept in the eye with the worse diabetic retinopathy and sham in the other.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'FG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of Eyes', 'groupId': 'FG000', 'numUnits': '200', 'numSubjects': '200'}, {'comment': 'Number of Eyes', 'groupId': 'FG001', 'numUnits': '199', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of Eyes', 'groupId': 'FG000', 'numUnits': '160', 'numSubjects': '160'}, {'comment': 'Number of Eyes', 'groupId': 'FG001', 'numUnits': '167', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '40', 'numSubjects': '40'}, {'groupId': 'FG001', 'numUnits': '32', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Completed out of Window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt aflibercept: Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'BG001', 'title': 'Sham', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.\n\nPrompt Sham: A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.\n\nDeferred laser: Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met\n\nDeferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '63'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '62'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}, {'title': 'Diabetes Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Type 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Type 2', 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}, {'title': 'Duration of Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '22'}, {'value': '16', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '22'}, {'value': '16', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'BG000', 'lowerLimit': '7.1', 'upperLimit': '10.0'}, {'value': '8.3', 'groupId': 'BG001', 'lowerLimit': '7.3', 'upperLimit': '9.7'}, {'value': '8.4', 'groupId': 'BG002', 'lowerLimit': '7.2', 'upperLimit': '9.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Hemoglobin A1c values were missing for 11 participants in the aflibercept group and 9 participants in the sham group', 'unitOfMeasure': 'Percent', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Mean arterial blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000', 'lowerLimit': '92', 'upperLimit': '107'}, {'value': '98', 'groupId': 'BG001', 'lowerLimit': '91', 'upperLimit': '106'}, {'value': '99', 'groupId': 'BG002', 'lowerLimit': '92', 'upperLimit': '106'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mean arterial blood pressure = (Systolic blood pressure + 2\\*Diastolic blood pressure) / 3', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Body mass index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '37'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '36'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Prior myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant', 'denomUnitsSelected': 'Participants'}, {'title': 'Prior stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant', 'denomUnitsSelected': 'Participants'}, {'title': 'Pre-existing renal disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant', 'denomUnitsSelected': 'Participants'}, {'title': 'Visual acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000', 'lowerLimit': '84', 'upperLimit': '90'}, {'value': '88', 'groupId': 'BG001', 'lowerLimit': '85', 'upperLimit': '91'}, {'value': '88', 'groupId': 'BG002', 'lowerLimit': '84', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Best corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. Best value on the scale 97, worst 0.', 'unitOfMeasure': 'letter score', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Optical coherence tomography central subfield thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000', 'lowerLimit': '264', 'upperLimit': '300'}, {'value': '283', 'groupId': 'BG001', 'lowerLimit': '265', 'upperLimit': '299'}, {'value': '283', 'groupId': 'BG002', 'lowerLimit': '264', 'upperLimit': '299'}]}]}], 'paramType': 'MEDIAN', 'description': 'Heidelberg Spectralis machine equivalent. Spectralis = 40.78 + 0.95 × cirrus.', 'unitOfMeasure': 'Microns', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Diabetic retinopathy severity scale level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Moderate NPDR (level 43)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Moderately severe NPDR (level 47A)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Moderately severe NPDR (level 47B-D)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Severe NPDR (level 53)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'NPDR= Non-proliferative diabetic retinopathy', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}, {'title': 'Intraocular pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '17'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '17'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Lens status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Posterior chamber Intraocular lens', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Phakic', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}, {'title': 'Non-central diabetic macular edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'At least 2 noncentral macular subfields with optical coherence tomography (OCT) thickness above threshold (average normal + 2 SD) or at least 1 noncentral macular subfield with OCT thickness at least 15 μm above threshold (average normal + 2 SD).', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Missing for 12 eyes in the aflibercept group and 4 eyes in the sham group'}, {'title': 'Prior anti-vascular endothelial growth factor therapy for diabetic macular edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}, {'title': 'Prior focal or grid laser for diabetic macular edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'Units are in eyes. A participant could have 2 study eyes. For participants with two study eyes the participant was randomly assigned to receive sham in the eye with worse diabetic retinopathy and aflibercept in the other, or aflibercept in the eye with the worse diabetic retinopathy and sham in the other.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-09', 'size': 878216, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-01T07:23', 'hasProtocol': True}, {'date': '2021-03-04', 'size': 429288, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-01T07:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2015-12-11', 'resultsFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-27', 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of PDR and/or DME (Whichever Came First)', 'timeFrame': '2 years', 'description': 'CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)'}, {'measure': 'Change in Visual Acuity From Baseline', 'timeFrame': '2 years', 'description': 'Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Acuity From Baseline', 'timeFrame': '4 years', 'description': 'Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.'}, {'measure': 'Development of PDR and/or DME (Whichever Came First)', 'timeFrame': '4 years', 'description': 'CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anti-vascular endothelial growth factor', 'nonproliferative diabetic retinopathy'], 'conditions': ['Diabetic Retinopathy', 'Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '36749332', 'type': 'DERIVED', 'citation': 'Maturi RK, Glassman AR, Josic K, Baker CW, Gerstenblith AT, Jampol LM, Meleth A, Martin DF, Melia M, Punjabi OS, Rofagha S, Salehi-Had H, Stockdale CR, Sun JK; DRCR Retina Network. Four-Year Visual Outcomes in the Protocol W Randomized Trial of Intravitreous Aflibercept for Prevention of Vision-Threatening Complications of Diabetic Retinopathy. JAMA. 2023 Feb 7;329(5):376-385. doi: 10.1001/jama.2022.25029.'}, {'pmid': '33784735', 'type': 'DERIVED', 'citation': 'Maturi RK, Glassman AR, Josic K, Antoszyk AN, Blodi BA, Jampol LM, Marcus DM, Martin DF, Melia M, Salehi-Had H, Stockdale CR, Punjabi OS, Sun JK; DRCR Retina Network. Effect of Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jul 1;139(7):701-712. doi: 10.1001/jamaophthalmol.2021.0606.'}]}, 'descriptionModule': {'briefSummary': 'Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently would result in favorable visual acuity outcomes.\n\nIf this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe non-proliferative diabetic retinopathy) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented.\n\nThe primary objectives of this protocol are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk PDR or CI-DME with vision loss develops.\n\nSecondary objectives include:\n\n* Comparing other visual acuity outcomes between treatment groups, such as proportion of eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at least 5 letters at the consecutive study visit just before and at the 2- or 4-year visit\n* Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT central subfield thickness and volume from baseline\n* Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of diabetic retinopathy severity level (scale for individual eyes) by central reading center from baseline\n* Comparing associated treatment and follow-up exam costs between treatment groups\n* Comparing safety outcomes between treatment groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Diagnosis of diabetes mellitus (type 1 or type 2)\n\n • Any one of the following will be considered to be sufficient evidence that diabetes is present:\n 1. Current regular use of insulin for the treatment of diabetes\n 2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes\n 3. Documented diabetes by American Diabetes Association and/or World Health Organization criteria\n3. Able and willing to provide informed consent.\n\nMeets all of the following ocular criteria in at least one eye:\n\n1. Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score ≥79 (approximate Snellen equivalent 20/25 or better)\n2. Severe non-proliferative diabetic retinopathy (NPDR) (based on the 4:2:1 rule) evident on clinical examination and on digital imaging as judged by the investigator. Reading center grading of less than ETDRS level 43 or greater than 53 is an exclusion.\n\n Severe NPDR is defined as:\n 1. All 4 midperipheral quadrants show severe hemorrhages or microaneurysms (at least as great as Standard photograph 2A, approximately 20 dot and blot hemorrhages), or\n 2. At least 2 fields of definite venous beading in the midperipheral quadrants or at least 1 field at least as severe as Standard photograph 6A, or\n 3. At least 1 field of moderate intraretinal microvascular abnormalities (IRMA) in the midperipheral quadrants, at least as severe as Standard photograph 8A\n3. No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed).\n4. No evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization.\n\n • The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned.\n5. No center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds:\n\n 1. Zeiss Cirrus: 290 µm in women and 305 µm in men\n 2. Heidelberg Spectralis: 305 µm in women and 320 µm in men\n 3. Investigator and potential participant are comfortable withholding treatment for DME until there is at least a 10% increase in OCT central subfield thickness with confirmed visual acuity loss (10 letter loss at a single visit or 5 to 9 at two consecutive visits).\n6. Prompt panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor (anti-VEGF) treatment not required AND investigator and potential participant are willing to wait for development of high-risk characteristics (defined in protocol) to treat PDR.\n7. Media clarity, pupillary dilation, and study participant cooperation sufficient to obtain adequate fundus photographs, fluorescein angiogram, and OCT.\n\n * Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality (including segmentation line placement)\n\nExclusion Criteria:\n\n1. History of chronic renal failure requiring dialysis or kidney transplant.\n2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).\n3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.\n4. Participation in an investigational trial that involved treatment within 30 days of randomization with any drug that has not received regulatory approval for the indication being studied.\n\n • Note: study participants cannot participate in another investigational trial that involves treatment with an investigational drug while participating in the study.\n5. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine prep).\n6. Known allergy to fluorescein dye.\n7. Blood pressure \\> 180/110 (systolic above 180 or diastolic above 110). • If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.\n8. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.\n\n • These drugs should not be used during the study.\n9. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 2 years.\n\n • Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.\n10. Individual is expecting to move out of the area of the clinical center to an area not covered by another Diabetic Retinopathy Clinical Research Network certified clinical center during the next 2 years.\n\nIndividual has any of the following ocular characteristics in the eye(s) being evaluated:\n\n1. Exam or photographic evidence of vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR.\n2. History of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR.\n3. History of prior PRP (defined as ≥100 burns outside of the posterior pole).\n4. An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.).\n5. History of DME or diabetic retinopathy treatment with laser or intraocular injections of medication within the prior 12 months and no more than 4 prior intraocular injections at any time in the past.\n\n • Enrollment will be limited to a maximum of 25% of the planned sample size with any history of treatment for DME and/or diabetic retinopathy. Once this number of eyes has been enrolled, any history of treatment for DME and/or diabetic retinopathy will be an exclusion criterion.\n6. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.\n7. Any history of vitrectomy.\n8. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization.\n9. Aphakia.\n10. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.\n11. Evidence of uncontrolled glaucoma.\n\n * Intraocular pressure must be \\<30, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible.'}, 'identificationModule': {'nctId': 'NCT02634333', 'briefTitle': 'Anti-VEGF Treatment for Prevention of PDR/DME', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'Intravitreous Anti-Vascular Endothelial Growth Factor Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk', 'orgStudyIdInfo': {'id': 'DRCR.net Protocol W'}, 'secondaryIdInfos': [{'id': 'EY14231', 'type': 'OTHER_GRANT', 'domain': 'National Eye Institute'}, {'id': 'EY23207', 'type': 'OTHER_GRANT', 'domain': 'National Eye Institute'}, {'id': 'EY18817', 'type': 'OTHER_GRANT', 'domain': 'National Eye Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Observation (Prompt Sham)', 'description': 'Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.', 'interventionNames': ['Procedure: Prompt Sham', 'Procedure: Deferred laser', 'Drug: Deferred aflibercept']}, {'type': 'EXPERIMENTAL', 'label': 'Prompt aflibercept', 'description': 'Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met.', 'interventionNames': ['Drug: Prompt aflibercept', 'Procedure: Deferred laser', 'Drug: Deferred aflibercept']}], 'interventions': [{'name': 'Prompt Sham', 'type': 'PROCEDURE', 'description': 'A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.', 'armGroupLabels': ['Observation (Prompt Sham)']}, {'name': 'Prompt aflibercept', 'type': 'DRUG', 'otherNames': ['intravitreal anti-vascular endothelial growth factor', 'Eylea'], 'description': 'Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.', 'armGroupLabels': ['Prompt aflibercept']}, {'name': 'Deferred laser', 'type': 'PROCEDURE', 'otherNames': ['focal/grid photocoagulation', 'panretinal photocoagulation'], 'description': 'Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met', 'armGroupLabels': ['Observation (Prompt Sham)', 'Prompt aflibercept']}, {'name': 'Deferred aflibercept', 'type': 'DRUG', 'otherNames': ['intravitreal anti-vascular endothelial growth factor', 'Eylea'], 'description': 'Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.', 'armGroupLabels': ['Observation (Prompt Sham)', 'Prompt aflibercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85021', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Retina and Vitreous Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Medical Center/Department of Ophthalmology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Atlantis Eye Care', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Health Care, Department of Ophthalmology', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'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, MC', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '93257', 'city': 'Porterville', 'state': 'California', 'country': 'United States', 'facility': 'Shashi D Ganti, MD PC', 'geoPoint': {'lat': 36.06523, 'lon': -119.01677}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants of Southern California', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'U.C. 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