Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-13 @ 8:29 AM
Study NCT ID:
NCT01903720
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.', 'otherNumAtRisk': 71, 'otherNumAffected': 44, 'seriousNumAtRisk': 71, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '51.90', 'spread': '13.55', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6 (n=62)', 'categories': [{'measurements': [{'value': '18.60', 'spread': '12.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Retinal Thickness (CRT) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '505.13', 'spread': '129.91', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6 (n=62)', 'categories': [{'measurements': [{'value': '-246.82', 'spread': '150.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.', 'unitOfMeasure': 'micrometers (μm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '51.90', 'spread': '13.55', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 12 (n=59)', 'categories': [{'measurements': [{'value': '15.27', 'spread': '14.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CRT at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '505.13', 'spread': '129.91', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 12 (n=59)', 'categories': [{'measurements': [{'value': '-196.90', 'spread': '164.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '51.90', 'spread': '13.55', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 1 (n=70)', 'categories': [{'measurements': [{'value': '12.80', 'spread': '10.69', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 1 (n=66)', 'categories': [{'measurements': [{'value': '16.08', 'spread': '10.75', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 2 (n=62)', 'categories': [{'measurements': [{'value': '18.84', 'spread': '12.16', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 3 (n=63)', 'categories': [{'measurements': [{'value': '17.59', 'spread': '12.90', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 4 (n=59)', 'categories': [{'measurements': [{'value': '14.37', 'spread': '13.47', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 5 (n=63)', 'categories': [{'measurements': [{'value': '18.10', 'spread': '13.44', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6 (n=62)', 'categories': [{'measurements': [{'value': '18.60', 'spread': '12.90', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 7 (n=60)', 'categories': [{'measurements': [{'value': '18.02', 'spread': '12.64', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 8 (n=61)', 'categories': [{'measurements': [{'value': '16.02', 'spread': '13.39', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 9 (n=59)', 'categories': [{'measurements': [{'value': '15.88', 'spread': '13.35', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 10 (n=60)', 'categories': [{'measurements': [{'value': '17.68', 'spread': '13.17', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 11 (n=59)', 'categories': [{'measurements': [{'value': '15.54', 'spread': '14.04', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 12 (n=59)', 'categories': [{'measurements': [{'value': '15.27', 'spread': '14.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants. "n" in the category is the number of participants with data available at the given time-point for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CRT at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '505.13', 'spread': '129.91', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 1 (n=70)', 'categories': [{'measurements': [{'value': '-173.67', 'spread': '140.57', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 1 (n=66)', 'categories': [{'measurements': [{'value': '-229.48', 'spread': '142.45', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 2 (n=62)', 'categories': [{'measurements': [{'value': '-255.55', 'spread': '139.01', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 3 (n=63)', 'categories': [{'measurements': [{'value': '-188.17', 'spread': '179.84', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 4 (n=59)', 'categories': [{'measurements': [{'value': '-100.76', 'spread': '150.97', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 5 (n=63)', 'categories': [{'measurements': [{'value': '-202.41', 'spread': '157.66', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6 (n=62)', 'categories': [{'measurements': [{'value': '-246.82', 'spread': '150.74', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 7 (n=60)', 'categories': [{'measurements': [{'value': '-220.13', 'spread': '143.07', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 8 (n=60)', 'categories': [{'measurements': [{'value': '-175.83', 'spread': '133.93', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 9 (n=59)', 'categories': [{'measurements': [{'value': '-211.46', 'spread': '158.10', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 10 (n=59)', 'categories': [{'measurements': [{'value': '-250.97', 'spread': '133.24', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 11 (n=59)', 'categories': [{'measurements': [{'value': '-219.14', 'spread': '144.47', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 12 (n=59)', 'categories': [{'measurements': [{'value': '-196.90', 'spread': '164.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.', 'unitOfMeasure': 'micrometers (μm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants. "n" in the category is the number of participants with data available at the given time-point for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'title': 'Month 6_Increase', 'categories': [{'measurements': [{'value': '64.52', 'groupId': 'OG000'}]}]}, {'title': 'Month 6_Decrease', 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Month 12_Increase (n=59)', 'categories': [{'measurements': [{'value': '55.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 12_Decrease (n=59)', 'categories': [{'measurements': [{'value': '5.08', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants. "n" in the category is the number of participants with data available at the given time-point for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Receiving a Second Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Receiving a Third Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Time to Second Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.78', 'spread': '6.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Time in weeks from the first injection to the second injection.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Time to Third Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.20', 'spread': '3.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Time in weeks from the second injection to the third injection.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Laser Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Inclusion / exclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Rescinding of informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Treatment with alternative drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.46', 'spread': '9.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '30 to 39 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': '60 to 69 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': '70 years and over', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2015-08-31', 'completionDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2013-07-16', 'dispFirstSubmitQcDate': '2015-08-31', 'resultsFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2013-07-18', 'dispFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-10', 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Central Retinal Thickness (CRT) at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.'}, {'measure': 'Change From Baseline in BCVA at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.'}, {'measure': 'Change From Baseline in CRT at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.'}, {'measure': 'Change From Baseline in BCVA at Each Visit', 'timeFrame': 'Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.'}, {'measure': 'Change From Baseline in CRT at Each Visit', 'timeFrame': 'Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12', 'description': 'CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.'}, {'measure': 'Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA', 'timeFrame': 'Baseline, Months 6 and 12', 'description': 'BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.'}, {'measure': 'Percentage of Participants Receiving a Second Injection', 'timeFrame': '12 Months'}, {'measure': 'Percentage of Participants Receiving a Third Injection', 'timeFrame': '12 Months'}, {'measure': 'Time to Second Injection', 'timeFrame': '12 Months', 'description': 'Time in weeks from the first injection to the second injection.'}, {'measure': 'Time to Third Injection', 'timeFrame': '12 Months', 'description': 'Time in weeks from the second injection to the third injection.'}, {'measure': 'Percentage of Participants Who Received Laser Treatments', 'timeFrame': '12 Months', 'description': 'Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Edema', 'Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '29642062', 'type': 'BACKGROUND', 'citation': 'Yoon YH, Kim JW, Lee JY, Kim IT, Kang SW, Yu HG, Koh HJ, Kim SS, Chang DJ, Simonyi S. Dexamethasone Intravitreal Implant for Early Treatment and Retreatment of Macular Edema Related to Branch Retinal Vein Occlusion: The Multicenter COBALT Study. Ophthalmologica. 2018;240(2):81-89. doi: 10.1159/000487547. Epub 2018 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of macular edema\n* Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye\n\nExclusion Criteria:\n\n* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month\n* Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months\n* Any active ocular infection in either eye'}, 'identificationModule': {'nctId': 'NCT01903720', 'acronym': 'COBALT', 'briefTitle': 'A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'APMA-OZU-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OZURDEX®', 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.', 'interventionNames': ['Drug: dexamethasone implant']}], 'interventions': [{'name': 'dexamethasone implant', 'type': 'DRUG', 'otherNames': ['OZURDEX®'], 'description': 'OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.', 'armGroupLabels': ['OZURDEX®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}