Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-04 @ 8:44 AM
Study NCT ID:
NCT00593450
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maguirem@mail.med.upenn.edu', 'phone': '215-615-1501', 'title': 'Dr. Maureen Maguire', 'organization': 'CATT Research Group'}, 'certainAgreement': {'otherDetails': 'Dr. Grunwald reports receiving consulting fees from GlaxoSmithKline; and Dr. Jaffe, consulting fees from Neurotech and SurModics. No other potential conflict of interest relevant to this article was reported.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected at 1 year.', 'description': 'Adverse events were ascertained through monthly questioning of patients by study coordinators who were aware of study-group assignments; events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) system, version 10. A medical monitor who was unaware of study-group assignments reviewed serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.', 'otherNumAtRisk': 301, 'otherNumAffected': 3, 'seriousNumAtRisk': 301, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.', 'otherNumAtRisk': 286, 'otherNumAffected': 4, 'seriousNumAtRisk': 286, 'seriousNumAffected': 64}, {'id': 'EG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.', 'otherNumAtRisk': 298, 'otherNumAffected': 0, 'seriousNumAtRisk': 298, 'seriousNumAffected': 61}, {'id': 'EG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.', 'otherNumAtRisk': 300, 'otherNumAffected': 0, 'seriousNumAtRisk': 300, 'seriousNumAffected': 77}], 'otherEvents': [{'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pseudoendophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Any other system organ class', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Benignor malignant neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death from any cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death from vascular causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injury or procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nonfatal myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nonfatal stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Surgical or medical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Venous thrombotic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline Visual-acuity Score (Frequency)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'title': 'Increase of ≥15 letters', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Increase of 5-14 letters', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Change of ≤4 letters', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Decrease of 5-14 letters', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Decrease of ≥15 letters', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Visual-acuity Score (Continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '5.9', 'spread': '15.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-0.5', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '2.9', 'pValueComment': 'This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'estimateComment': 'Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group', 'groupDescription': 'The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.', 'nonInferiorityComment': 'The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \\[ETDRS\\] visual-acuity chart)'}, {'pValue': '0.16', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-0.8', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '2.4', 'pValueComment': 'This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'estimateComment': 'Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group', 'groupDescription': 'The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.', 'nonInferiorityComment': 'The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \\[ETDRS\\] visual-acuity chart)'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-1.7', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '1.3', 'pValueComment': 'This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.5', 'estimateComment': 'Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group', 'groupDescription': 'The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.', 'nonInferiorityComment': 'The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \\[ETDRS\\] visual-acuity chart)'}, {'pValue': '0.16', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-2.1', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '1.6', 'pValueComment': 'This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'estimateComment': 'Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group', 'groupDescription': 'The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.', 'nonInferiorityComment': 'The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \\[ETDRS\\] visual-acuity chart)'}, {'pValue': '0.16', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-1.2', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '2.1', 'pValueComment': 'This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'estimateComment': 'Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group', 'groupDescription': 'The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.', 'nonInferiorityComment': 'The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \\[ETDRS\\] visual-acuity chart)'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-2.6', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '0.8', 'pValueComment': 'This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'estimateComment': 'Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group', 'groupDescription': 'The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.', 'nonInferiorityComment': 'The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \\[ETDRS\\] visual-acuity chart)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'description': 'Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.\n\nIn this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.', 'unitOfMeasure': 'No. of Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had VA measured at week 52 were included in the analysis. All analyses were performed on the basis of the intention-to-treat principle. The Data and Safety Monitoring Committee recommended that data for all 23 patients at one center be excluded because of serious protocol noncompliance.'}, {'type': 'SECONDARY', 'title': 'Visual-acuity Score and Snellen Equivalent (Frequency)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'title': '83-97 letters, 20/12-20', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': '68-82 letters, 20/25-40', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}]}, {'title': '53-67 letters, 20/50-80', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': '38-52 letters, 20/100-160', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': '≤37 letters, ≤20/200', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual-acuity Score and Snellen Equivalent (Continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '68.4', 'spread': '16.4', 'groupId': 'OG002'}, {'value': '66.5', 'spread': '19.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 1 Year', 'description': 'Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.\n\nIn this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.', 'unitOfMeasure': 'No. of Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '3.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Cumulative over the 1 year of trial', 'unitOfMeasure': 'Number of Treatments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Cost of Drug/Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '23400', 'spread': '3000', 'groupId': 'OG000'}, {'value': '595', 'spread': '60', 'groupId': 'OG001'}, {'value': '13800', 'spread': '6000', 'groupId': 'OG002'}, {'value': '385', 'spread': '175', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'US dollars per patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Thickness at Fovea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '266', 'spread': '125', 'groupId': 'OG000'}, {'value': '300', 'spread': '149', 'groupId': 'OG001'}, {'value': '294', 'spread': '139', 'groupId': 'OG002'}, {'value': '308', 'spread': '127', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Thickness Change From Baseline at Fovea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-196', 'spread': '176', 'groupId': 'OG000'}, {'value': '-164', 'spread': '181', 'groupId': 'OG001'}, {'value': '-168', 'spread': '186', 'groupId': 'OG002'}, {'value': '-152', 'spread': '178', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'spread': '57', 'groupId': 'OG000'}, {'value': '172', 'spread': '81', 'groupId': 'OG001'}, {'value': '166', 'spread': '66', 'groupId': 'OG002'}, {'value': '172', 'spread': '68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-100', 'spread': '130', 'groupId': 'OG000'}, {'value': '-79', 'spread': '132', 'groupId': 'OG001'}, {'value': '-81', 'spread': '134', 'groupId': 'OG002'}, {'value': '-79', 'spread': '123', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluid on Optical Coherence Tomography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}]}]}, {'title': 'Data missing', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dye Leakage on Angiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}]}, {'title': 'Data missing', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area of Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}, {'value': '249', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '7.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 1 Year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area of Lesion Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}, {'value': '241', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '6.2', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '6.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '232', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '20.3', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '20.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '232', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'OG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'OG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'OG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '10.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'FG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'FG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'FG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '286'}, {'groupId': 'FG002', 'numSubjects': '298'}, {'groupId': 'FG003', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '265'}, {'groupId': 'FG002', 'numSubjects': '285'}, {'groupId': 'FG003', 'numSubjects': '271'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '29'}]}]}], 'preAssignmentDetails': 'Note: The Data and Safety Monitoring Committee for CATT recommended excluding the data for all patients (N=23) from one center because of serious protocol non-compliance. Unless specified otherwise, only the 1185 patients enrolled by the remaining 43 centers are included in analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '1185', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1-Lucentis Monthly', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.'}, {'id': 'BG001', 'title': '2-Avastin Monthly', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.'}, {'id': 'BG002', 'title': '3-Lucentis as Needed', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'BG003', 'title': '4-Avastin as Needed', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '80.1', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '78.4', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '79.3', 'spread': '7.6', 'groupId': 'BG003'}, {'value': '79.3', 'spread': '7.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '50-59 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '404', 'groupId': 'BG004'}]}]}, {'title': '80-89 years', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '560', 'groupId': 'BG004'}]}]}, {'title': '>=90 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}, {'value': '732', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '453', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}, {'value': '1168', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'History of myocardial infarction', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}, {'value': '1045', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'History of stroke', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '284', 'groupId': 'BG003'}, {'value': '1115', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'History of transient ischemic attack', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}, {'value': '281', 'groupId': 'BG003'}, {'value': '1117', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '134', 'spread': '18', 'groupId': 'BG000'}, {'value': '135', 'spread': '19', 'groupId': 'BG001'}, {'value': '136', 'spread': '17', 'groupId': 'BG002'}, {'value': '135', 'spread': '17', 'groupId': 'BG003'}, {'value': '135', 'spread': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '10', 'groupId': 'BG000'}, {'value': '75', 'spread': '10', 'groupId': 'BG001'}, {'value': '76', 'spread': '9', 'groupId': 'BG002'}, {'value': '75', 'spread': '10', 'groupId': 'BG003'}, {'value': '75', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Visual-acuity score and Snellen equivalent', 'classes': [{'title': '68-82 letters, 20/25-40', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '424', 'groupId': 'BG004'}]}]}, {'title': '53-67 letters, 20/50-80', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '443', 'groupId': 'BG004'}]}]}, {'title': '38-52 letters, 20/100-160', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}]}]}, {'title': '23-37 letters, 20/200-320', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Visual-acuity score and Snellen equivalent', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '13.4', 'groupId': 'BG003'}, {'value': '60.5', 'spread': '13.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.\n\nIn this study, the visual acuity letter score is ranged from 23 to 82, with the higher score the better visual acuity.', 'unitOfMeasure': 'Letters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total thickness at fovea', 'classes': [{'categories': [{'measurements': [{'value': '458', 'spread': '184', 'groupId': 'BG000'}, {'value': '463', 'spread': '196', 'groupId': 'BG001'}, {'value': '458', 'spread': '193', 'groupId': 'BG002'}, {'value': '461', 'spread': '175', 'groupId': 'BG003'}, {'value': '460', 'spread': '187', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Retinal thickness plus subfoveal-fluid thickness at fovea', 'classes': [{'categories': [{'measurements': [{'value': '251', 'spread': '122', 'groupId': 'BG000'}, {'value': '254', 'spread': '121', 'groupId': 'BG001'}, {'value': '247', 'spread': '122', 'groupId': 'BG002'}, {'value': '252', 'spread': '115', 'groupId': 'BG003'}, {'value': '251', 'spread': '120', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Foveal center involvement', 'classes': [{'title': 'Choroidal neovacularization', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}, {'value': '688', 'groupId': 'BG004'}]}]}, {'title': 'Fluid', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '315', 'groupId': 'BG004'}]}]}, {'title': 'Hemorrhage', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}, {'title': "No choroidal neovascularization or can't grade", 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2008-01-03', 'resultsFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2008-01-03', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-21', 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Visual-acuity Score (Continuous)', 'timeFrame': 'Baseline and 1 Year', 'description': 'Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.\n\nIn this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Visual-acuity Score (Frequency)', 'timeFrame': 'Baseline and 1 Year'}, {'measure': 'Visual-acuity Score and Snellen Equivalent (Frequency)', 'timeFrame': 'at 1 Year'}, {'measure': 'Visual-acuity Score and Snellen Equivalent (Continuous)', 'timeFrame': 'at 1 Year', 'description': 'Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.\n\nIn this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.'}, {'measure': 'Number of Treatments', 'timeFrame': '1 Year', 'description': 'Cumulative over the 1 year of trial'}, {'measure': 'Average Cost of Drug/Patient', 'timeFrame': 'at 1 Year'}, {'measure': 'Total Thickness at Fovea', 'timeFrame': 'at 1 Year'}, {'measure': 'Total Thickness Change From Baseline at Fovea', 'timeFrame': 'Baseline and 1 Year'}, {'measure': 'Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea', 'timeFrame': 'at 1 Year'}, {'measure': 'Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea', 'timeFrame': 'Baseline and 1 Year'}, {'measure': 'Fluid on Optical Coherence Tomography', 'timeFrame': 'at 1 Year'}, {'measure': 'Dye Leakage on Angiogram', 'timeFrame': 'at 1 Year'}, {'measure': 'Area of Lesion', 'timeFrame': 'at 1 Year'}, {'measure': 'Area of Lesion Change From Baseline', 'timeFrame': 'Baseline and 1 Year'}, {'measure': 'Change in Systolic Blood Pressure From Baseline', 'timeFrame': 'Baseline and 1 Year'}, {'measure': 'Change in Diastolic Blood Pressure From Baseline', 'timeFrame': 'Baseline and 1 Year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bevacizumab', 'ranibizumab', 'choroidal neovascularization'], 'conditions': ['Age Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '20519677', 'type': 'BACKGROUND', 'citation': 'Martin DF, Maguire MG, Fine SL. Identifying and eliminating the roadblocks to comparative-effectiveness research. N Engl J Med. 2010 Jul 8;363(2):105-7. doi: 10.1056/NEJMp1001201. Epub 2010 Jun 2. No abstract available.'}, {'pmid': '21526923', 'type': 'RESULT', 'citation': 'CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.'}, {'pmid': '22555112', 'type': 'RESULT', 'citation': 'Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group; Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, Toth C, Redford M, Ferris FL 3rd. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012 Jul;119(7):1388-98. doi: 10.1016/j.ophtha.2012.03.053. Epub 2012 May 1.'}, {'pmid': '22512984', 'type': 'RESULT', 'citation': 'Grunwald JE, Daniel E, Ying GS, Pistilli M, Maguire MG, Alexander J, Whittock-Martin R, Parker CR, Sepielli K, Blodi BA, Martin DF; CATT Research Group. Photographic assessment of baseline fundus morphologic features in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2012 Aug;119(8):1634-41. doi: 10.1016/j.ophtha.2012.02.013. Epub 2012 Apr 17.'}, {'pmid': '22452699', 'type': 'RESULT', 'citation': 'Martin DF, Maguire MG, Fine SL. Bevacizumab: not as good with more adverse reactions? Response. Clin Exp Ophthalmol. 2011 Sep-Oct;39(7):718-20. doi: 10.1111/j.1442-9071.2011.02703.x. No abstract available.'}, {'pmid': '22150050', 'type': 'RESULT', 'citation': 'Cheung CM, Wong TY. Ranibizumab and bevacizumab for AMD. N Engl J Med. 2011 Dec 8;365(23):2237; author reply 2237. doi: 10.1056/NEJMc1107895. No abstract available.'}, {'pmid': '22939114', 'type': 'RESULT', 'citation': 'DeCroos FC, Toth CA, Stinnett SS, Heydary CS, Burns R, Jaffe GJ; CATT Research Group. Optical coherence tomography grading reproducibility during the Comparison of Age-related Macular Degeneration Treatments Trials. Ophthalmology. 2012 Dec;119(12):2549-57. doi: 10.1016/j.ophtha.2012.06.040. Epub 2012 Aug 28.'}, {'pmid': '23047002', 'type': 'RESULT', 'citation': 'Ying GS, Huang J, Maguire MG, Jaffe GJ, Grunwald JE, Toth C, Daniel E, Klein M, Pieramici D, Wells J, Martin DF; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Baseline predictors for one-year visual outcomes with ranibizumab or bevacizumab for neovascular age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):122-9. doi: 10.1016/j.ophtha.2012.07.042. Epub 2012 Oct 6.'}, {'pmid': '23337555', 'type': 'RESULT', 'citation': 'Hagstrom SA, Ying GS, Pauer GJT, Sturgill-Short GM, Huang J, Callanan DG, Kim IK, Klein ML, Maguire MG, Martin DF; Comparison of AMD Treatments Trials Research Group. Pharmacogenetics for genes associated with age-related macular degeneration in the Comparison of AMD Treatments Trials (CATT). Ophthalmology. 2013 Mar;120(3):593-599. doi: 10.1016/j.ophtha.2012.11.037. Epub 2013 Jan 18.'}, {'pmid': '23642377', 'type': 'RESULT', 'citation': 'Jaffe GJ, Martin DF, Toth CA, Daniel E, Maguire MG, Ying GS, Grunwald JE, Huang J; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular morphology and visual acuity in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2013 Sep;120(9):1860-70. doi: 10.1016/j.ophtha.2013.01.073. Epub 2013 May 1.'}, {'pmid': '23706946', 'type': 'RESULT', 'citation': 'Maguire MG, Daniel E, Shah AR, Grunwald JE, Hagstrom SA, Avery RL, Huang J, Martin RW, Roth DB, Castellarin AA, Bakri SJ, Fine SL, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT Research Group). Incidence of choroidal neovascularization in the fellow eye in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2013 Oct;120(10):2035-41. doi: 10.1016/j.ophtha.2013.03.017. Epub 2013 May 22.'}, {'pmid': '24314839', 'type': 'RESULT', 'citation': 'Daniel E, Toth CA, Grunwald JE, Jaffe GJ, Martin DF, Fine SL, Huang J, Ying GS, Hagstrom SA, Winter K, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Risk of scar in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Mar;121(3):656-66. doi: 10.1016/j.ophtha.2013.10.019. Epub 2013 Dec 4.'}, {'pmid': '24084496', 'type': 'RESULT', 'citation': 'Grunwald JE, Daniel E, Huang J, Ying GS, Maguire MG, Toth CA, Jaffe GJ, Fine SL, Blodi B, Klein ML, Martin AA, Hagstrom SA, Martin DF; CATT Research Group. Risk of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Jan;121(1):150-161. doi: 10.1016/j.ophtha.2013.08.015. Epub 2013 Sep 29.'}, {'pmid': '24652518', 'type': 'RESULT', 'citation': 'Hagstrom SA, Ying GS, Pauer GJ, Sturgill-Short GM, Huang J, Maguire MG, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. VEGFA and VEGFR2 gene polymorphisms and response to anti-vascular endothelial growth factor therapy: comparison of age-related macular degeneration treatments trials (CATT). JAMA Ophthalmol. 2014 May;132(5):521-7. doi: 10.1001/jamaophthalmol.2014.109.'}, {'pmid': '24727261', 'type': 'RESULT', 'citation': 'Kim BJ, Ying GS, Huang J, Levy NE, Maguire MG; CATT Research Group. Sporadic visual acuity loss in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol. 2014 Jul;158(1):128-135.e10. doi: 10.1016/j.ajo.2014.04.004. Epub 2014 Apr 13.'}, {'pmid': '24835760', 'type': 'RESULT', 'citation': 'Folgar FA, Jaffe GJ, Ying GS, Maguire MG, Toth CA; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Comparison of optical coherence tomography assessments in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Oct;121(10):1956-65. doi: 10.1016/j.ophtha.2014.04.020. Epub 2014 May 15.'}, {'pmid': '24875610', 'type': 'RESULT', 'citation': 'Ying GS, Kim BJ, Maguire MG, Huang J, Daniel E, Jaffe GJ, Grunwald JE, Blinder KJ, Flaxel CJ, Rahhal F, Regillo C, Martin DF; CATT Research Group. Sustained visual acuity loss in the comparison of age-related macular degeneration treatments trials. JAMA Ophthalmol. 2014 Aug;132(8):915-21. doi: 10.1001/jamaophthalmol.2014.1019.'}, {'pmid': '24949820', 'type': 'RESULT', 'citation': 'Gewaily DY, Grunwald JE, Pistilli M, Ying GS, Maguire MG, Daniel E, Ostroff CP, Fine SL; CATT Research Group. Delayed patchy choroidal filling in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol. 2014 Sep;158(3):525-31.e2. doi: 10.1016/j.ajo.2014.06.004. Epub 2014 Jun 17.'}, {'pmid': '25064723', 'type': 'RESULT', 'citation': 'Lee JY, Folgar FA, Maguire MG, Ying GS, Toth CA, Martin DF, Jaffe GJ; CATT Research Group. Outer retinal tubulation in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmology. 2014 Dec;121(12):2423-31. doi: 10.1016/j.ophtha.2014.06.013. Epub 2014 Jul 23.'}, {'pmid': '25220133', 'type': 'RESULT', 'citation': "Moja L, Lucenteforte E, Kwag KH, Bertele V, Campomori A, Chakravarthy U, D'Amico R, Dickersin K, Kodjikian L, Lindsley K, Loke Y, Maguire M, Martin DF, Mugelli A, Muhlbauer B, Puntmann I, Reeves B, Rogers C, Schmucker C, Subramanian ML, Virgili G. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Sep 15;9(9):CD011230. doi: 10.1002/14651858.CD011230.pub2."}, {'pmid': '25307130', 'type': 'RESULT', 'citation': 'Altaweel MM, Daniel E, Martin DF, Mittra RA, Grunwald JE, Lai MM, Melamud A, Morse LS, Huang J, Ferris FL 3rd, Fine SL, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group; Comparison of Age-related Macular Degeneration Treatments Trials CATT Research Group. Outcomes of eyes with lesions composed of >50% blood in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT). Ophthalmology. 2015 Feb;122(2):391-398.e5. doi: 10.1016/j.ophtha.2014.08.020. Epub 2014 Oct 11.'}, {'pmid': '25542520', 'type': 'RESULT', 'citation': 'Grunwald JE, Pistilli M, Ying GS, Maguire MG, Daniel E, Martin DF; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Growth of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2015 Apr;122(4):809-16. doi: 10.1016/j.ophtha.2014.11.007. Epub 2014 Dec 24.'}, {'pmid': '25600198', 'type': 'RESULT', 'citation': 'Meredith TA, McCannel CA, Barr C, Doft BH, Peskin E, Maguire MG, Martin DF, Prenner JL; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Postinjection endophthalmitis in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmology. 2015 Apr;122(4):817-21. doi: 10.1016/j.ophtha.2014.10.027. Epub 2015 Jan 15.'}, {'pmid': '26102433', 'type': 'RESULT', 'citation': 'Toth CA, Decroos FC, Ying GS, Stinnett SS, Heydary CS, Burns R, Maguire M, Martin D, Jaffe GJ. IDENTIFICATION OF FLUID ON OPTICAL COHERENCE TOMOGRAPHY BY TREATING OPHTHALMOLOGISTS VERSUS A READING CENTER IN THE COMPARISON OF AGE-RELATED MACULAR DEGENERATION TREATMENTS TRIALS. Retina. 2015 Jul;35(7):1303-14. doi: 10.1097/IAE.0000000000000483.'}, {'pmid': '25824327', 'type': 'RESULT', 'citation': 'Ciulla TA, Ying GS, Maguire MG, Martin DF, Jaffe GJ, Grunwald JE, Daniel E, Toth CA; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Influence of the Vitreomacular Interface on Treatment Outcomes in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2015 Jun;122(6):1203-11. doi: 10.1016/j.ophtha.2015.02.031. Epub 2015 Mar 29.'}, {'pmid': '26028346', 'type': 'RESULT', 'citation': 'Hagstrom SA, Ying GS, Maguire MG, Martin DF; CATT Research Group; Gibson J, Lotery A, Chakravarthy U; IVAN Study Investigators. VEGFR2 Gene Polymorphisms and Response to Anti-Vascular Endothelial Growth Factor Therapy in Age-Related Macular Degeneration. Ophthalmology. 2015 Aug;122(8):1563-8. doi: 10.1016/j.ophtha.2015.04.024. Epub 2015 May 28.'}, {'pmid': '26143666', 'type': 'RESULT', 'citation': 'Willoughby AS, Ying GS, Toth CA, Maguire MG, Burns RE, Grunwald JE, Daniel E, Jaffe GJ; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Subretinal Hyperreflective Material in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2015 Sep;122(9):1846-53.e5. doi: 10.1016/j.ophtha.2015.05.042. Epub 2015 Jul 2.'}, {'pmid': '26383996', 'type': 'RESULT', 'citation': 'Ying GS, Maguire MG, Daniel E, Ferris FL, Jaffe GJ, Grunwald JE, Toth CA, Huang J, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. Association of Baseline Characteristics and Early Vision Response with 2-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT). Ophthalmology. 2015 Dec;122(12):2523-31.e1. doi: 10.1016/j.ophtha.2015.08.015. Epub 2015 Sep 15.'}, {'pmid': '26545320', 'type': 'RESULT', 'citation': 'Ying GS, Maguire MG, Daniel E, Grunwald JE, Ahmed O, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Association between Antiplatelet or Anticoagulant Drugs and Retinal or Subretinal Hemorrhage in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Feb;123(2):352-360. doi: 10.1016/j.ophtha.2015.09.046. Epub 2015 Nov 4.'}, {'pmid': '26681392', 'type': 'RESULT', 'citation': 'Daniel E, Shaffer J, Ying GS, Grunwald JE, Martin DF, Jaffe GJ, Maguire MG; Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group. Outcomes in Eyes with Retinal Angiomatous Proliferation in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Ophthalmology. 2016 Mar;123(3):609-16. doi: 10.1016/j.ophtha.2015.10.034. Epub 2015 Dec 8.'}, {'pmid': '26778329', 'type': 'RESULT', 'citation': 'Shah N, Maguire MG, Martin DF, Shaffer J, Ying GS, Grunwald JE, Toth CA, Jaffe GJ, Daniel E; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Angiographic Cystoid Macular Edema and Outcomes in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Apr;123(4):858-64. doi: 10.1016/j.ophtha.2015.11.030. Epub 2016 Jan 8.'}, {'pmid': '26783095', 'type': 'RESULT', 'citation': 'Sharma S, Toth CA, Daniel E, Grunwald JE, Maguire MG, Ying GS, Huang J, Martin DF, Jaffe GJ; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular Morphology and Visual Acuity in the Second Year of the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Apr;123(4):865-75. doi: 10.1016/j.ophtha.2015.12.002. Epub 2016 Jan 9.'}, {'pmid': '27040149', 'type': 'RESULT', 'citation': 'Zhou Q, Daniel E, Maguire MG, Grunwald JE, Martin ER, Martin DF, Ying GS; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Pseudodrusen and Incidence of Late Age-Related Macular Degeneration in Fellow Eyes in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016 Jul;123(7):1530-40. doi: 10.1016/j.ophtha.2016.02.043. Epub 2016 Apr 1.'}, {'pmid': '27099955', 'type': 'RESULT', 'citation': 'Maguire MG, Ying GS, Jaffe GJ, Toth CA, Daniel E, Grunwald J, Martin DF, Hagstrom SA; CATT Research Group. Single-Nucleotide Polymorphisms Associated With Age-Related Macular Degeneration and Lesion Phenotypes in the Comparison of Age-Related Macular Degeneration Treatments Trials. JAMA Ophthalmol. 2016 Jun 1;134(6):674-81. doi: 10.1001/jamaophthalmol.2016.0669.'}, {'pmid': '35428655', 'type': 'DERIVED', 'citation': 'Core JQ, Hua P, Daniel E, Grunwald JE, Jaffe G, Maguire MG, Ying GS; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Thiazolidinedione use and retinal fluid in the comparison of age-related macular degeneration treatments trials. Br J Ophthalmol. 2023 Jul;107(7):1000-1006. doi: 10.1136/bjophthalmol-2021-320665. Epub 2022 Apr 15.'}, {'pmid': '35405352', 'type': 'DERIVED', 'citation': 'Core JQ, Pistilli M, Hua P, Daniel E, Grunwald JE, Toth CA, Jaffe GJ, Martin DF, Maguire MG, Ying GS; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Predominantly Persistent Intraretinal Fluid in the Comparison of Age-related Macular Degeneration Treatments Trials. Ophthalmol Retina. 2022 Sep;6(9):771-785. doi: 10.1016/j.oret.2022.03.024. Epub 2022 Apr 9.'}, {'pmid': '32383840', 'type': 'DERIVED', 'citation': 'Kolomeyer AM, Smith E, Daniel E, Ying GS, Pan W, Pistilli M, Grunwald J, Maguire MG, Kim BJ; CATT Research Group. BETA-PERIPAPILLARY ATROPHY AND GEOGRAPHIC ATROPHY IN THE COMPARISON OF AGE-RELATED MACULAR DEGENERATION TREATMENTS TRIALS. Retina. 2021 Jan 1;41(1):125-134. doi: 10.1097/IAE.0000000000002825.'}, {'pmid': '32374423', 'type': 'DERIVED', 'citation': 'Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.'}, {'pmid': '32191267', 'type': 'DERIVED', 'citation': 'Daniel E, Maguire MG, Grunwald JE, Toth CA, Jaffe GJ, Martin DF, Ying GS; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Incidence and Progression of Nongeographic Atrophy in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Clinical Trial. JAMA Ophthalmol. 2020 May 1;138(5):510-518. doi: 10.1001/jamaophthalmol.2020.0437.'}, {'pmid': '32027349', 'type': 'DERIVED', 'citation': 'Ramakrishnan MS, Yu Y, VanderBeek BL. Association of Visit Adherence and Visual Acuity in Patients With Neovascular Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial. JAMA Ophthalmol. 2020 Mar 1;138(3):237-242. doi: 10.1001/jamaophthalmol.2019.4577.'}, {'pmid': '31999297', 'type': 'DERIVED', 'citation': 'Scoles D, Ying GS, Pan W, Hua P, Grunwald JE, Daniel E, Jaffe GJ, Toth CA, Martin DF, Maguire MG; Comparison of AMD Treatments Trials Research Group. Characteristics of Eyes With Good Visual Acuity at 5 Years After Initiation of Treatment for Age-Related Macular Degeneration but Not Receiving Treatment From Years 3 to 5: Post Hoc Analysis of the CATT Randomized Clinical Trial. JAMA Ophthalmol. 2020 Mar 1;138(3):276-284. doi: 10.1001/jamaophthalmol.2019.5831.'}, {'pmid': '31513262', 'type': 'DERIVED', 'citation': 'Bavinger JC, Ying GS, Daniel E, Grunwald JE, Maguire MG; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Association Between Cilioretinal Arteries and Advanced Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT). JAMA Ophthalmol. 2019 Nov 1;137(11):1306-1311. doi: 10.1001/jamaophthalmol.2019.3509.'}, {'pmid': '31014683', 'type': 'DERIVED', 'citation': 'Toth CA, Tai V, Pistilli M, Chiu SJ, Winter KP, Daniel E, Grunwald JE, Jaffe GJ, Martin DF, Ying GS, Farsiu S, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Distribution of OCT Features within Areas of Macular Atrophy or Scar after 2 Years of Anti-VEGF Treatment for Neovascular AMD in CATT. Ophthalmol Retina. 2019 Apr;3(4):316-325. doi: 10.1016/j.oret.2018.11.011. Epub 2018 Dec 3.'}, {'pmid': '30476517', 'type': 'DERIVED', 'citation': 'Daniel E, Ying GS, Kim BJ, Toth CA, Ferris F 3rd, Martin DF, Grunwald JE, Jaffe GJ, Dunaief JL, Pan W, Maguire MG; Comparison of Age-Related Macular Degeneration Treatments Trials. Five-Year Follow-up of Nonfibrotic Scars in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2019 May;126(5):743-751. doi: 10.1016/j.ophtha.2018.11.020. Epub 2018 Nov 23.'}, {'pmid': '30189282', 'type': 'DERIVED', 'citation': 'Jaffe GJ, Ying GS, Toth CA, Daniel E, Grunwald JE, Martin DF, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Macular Morphology and Visual Acuity in Year Five of the Comparison of Age-related Macular Degeneration Treatments Trials. Ophthalmology. 2019 Feb;126(2):252-260. doi: 10.1016/j.ophtha.2018.08.035. Epub 2018 Sep 3.'}, {'pmid': '29454660', 'type': 'DERIVED', 'citation': 'Daniel E, Pan W, Ying GS, Kim BJ, Grunwald JE, Ferris FL 3rd, Jaffe GJ, Toth CA, Martin DF, Fine SL, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials. Development and Course of Scars in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2018 Jul;125(7):1037-1046. doi: 10.1016/j.ophtha.2018.01.004. Epub 2018 Feb 14.'}, {'pmid': '28079023', 'type': 'DERIVED', 'citation': 'Grunwald JE, Pistilli M, Daniel E, Ying GS, Pan W, Jaffe GJ, Toth CA, Hagstrom SA, Maguire MG, Martin DF; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group. Incidence and Growth of Geographic Atrophy during 5 Years of Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2017 Jan;124(1):97-104. doi: 10.1016/j.ophtha.2016.09.012. Epub 2016 Oct 27.'}], 'seeAlsoLinks': [{'url': 'http://www.med.upenn.edu/cpob/catt.html', 'label': 'Click here for more information about this study: Comparison of AMD Treatments Trials (CATT)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.\n\nA five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.', 'detailedDescription': 'Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD.\n\nLucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®.\n\nIn addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy.\n\nOnly a single eye in each patient was analyzed.\n\nAt the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active, subfoveal choroidal neovascularization (CNV)\n* Fibrosis \\< 50% of total lesion area\n* Visual acuity (VA) 20/25-20/320\n* Age ≥ 50 yrs\n* At least 1 drusen (\\>63μ) in either eye or late AMD in fellow eye\n\nExclusion Criteria:\n\n* Previous treatment for CNV in study eye\n* Other progressive retinal disease likely to compromise VA\n* Contraindications to injections with Lucentis or Avastin'}, 'identificationModule': {'nctId': 'NCT00593450', 'briefTitle': 'Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)', 'orgStudyIdInfo': {'id': 'NEI-137'}, 'secondaryIdInfos': [{'id': 'U10EY017823', 'link': 'https://reporter.nih.gov/quickSearch/U10EY017823', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.', 'interventionNames': ['Drug: ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.', 'interventionNames': ['Drug: bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.', 'interventionNames': ['Drug: ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.', 'interventionNames': ['Drug: bevacizumab']}], 'interventions': [{'name': 'ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': '• 0.5 mg (0.05 mL)intravitreal injection', 'armGroupLabels': ['1', '3']}, {'name': 'bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': '• 1.25 mg (0.05 mL)intravitreal injection', 'armGroupLabels': ['2', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 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