Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-09 @ 5:46 AM
Study NCT ID:
NCT01618266
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2012-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to 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': 'Vice President Medical Affairs,', '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® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.', 'otherNumAtRisk': 375, 'otherNumAffected': 252, 'seriousNumAtRisk': 375, 'seriousNumAffected': 98}], 'otherEvents': [{'term': 'Ocular Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 128}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 124}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}], 'seriousEvents': [{'term': 'Ocular Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 32}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 26}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Cataract Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Vitreous Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Macular Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Subscapular Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Sudden Falls Due to Legs Giving Way', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Detached Retina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Cardiopulmonary Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Macular Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Benign Prostatic Hyperplasia', 'notes': 'MALES ONLY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Pulmonary Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Retinal Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Herpetic Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Acute Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Coronary Artery Bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Pulmonary Arterial Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Pulmonary Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Prostate tumour', 'notes': 'MALES ONLY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47.56', 'spread': '21.21', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6 (N=323)', 'categories': [{'measurements': [{'value': '5.09', 'spread': '19.02', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.80', 'spread': '17.42', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '5.50', 'spread': '19.59', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. BRVO is a blockage of the small veins in the retina.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with BRVO'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.45', 'spread': '23.54', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '4.63', 'spread': '18.38', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. CRVO is a blockage of the main vein in the retina.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with CRVO'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.94', 'spread': '23.12', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '7.45', 'spread': '20.00', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Treatment naïve patients have not been previously treated for retinal vein occlusion.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients who were treatment naïve'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.46', 'spread': '18.90', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '1.95', 'spread': '16.03', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Previous treatment for retinal vein occlusion was Ozurdex®.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients previously treated with Ozurdex®'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.29', 'spread': '20.20', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '8.39', 'spread': '21.10', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients previously naïve to Ozurdex® treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.27', 'spread': '22.83', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '8.53', 'spread': '20.50', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. The onset of macular edema was \\<3 months prior to treatment.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with macular edema onset \\<3 months'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '51.44', 'spread': '19.00', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '1.96', 'spread': '17.47', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. The onset of macular edema was ≥3 months prior to treatment.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with macular edema onset ≥3 months'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '49.28', 'spread': '19.23', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '5.48', 'spread': '18.77', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Patients had only been previously treated with Ozurdex®.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients only treated with Ozurdex'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.97', 'spread': '24.57', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '4.25', 'spread': '19.61', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients receiving Ozurdex® and then other RVO treatments'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47.6', 'spread': '21.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 6 (N=350)', 'categories': [{'measurements': [{'value': '11.41', 'spread': '16.4', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 4 (N=337)', 'categories': [{'measurements': [{'value': '3.08', 'spread': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 12 (N=306)', 'categories': [{'measurements': [{'value': '2.85', 'spread': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 18 (N=287)', 'categories': [{'measurements': [{'value': '3.02', 'spread': '22.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 24 (N=274)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '22.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, Month 4, Month 12, Month 18, Month 24', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 24', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Treatment satisfaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ozurdex® (Dexamethasone Intravitreal Implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.31', 'spread': '11.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '206', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2012-06-11', 'resultsFirstSubmitDate': '2016-01-13', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-13', 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. BRVO is a blockage of the small veins in the retina.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. CRVO is a blockage of the main vein in the retina.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Treatment naïve patients have not been previously treated for retinal vein occlusion.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Previous treatment for retinal vein occlusion was Ozurdex®.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. The onset of macular edema was \\<3 months prior to treatment.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. The onset of macular edema was ≥3 months prior to treatment.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Patients had only been previously treated with Ozurdex®.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.'}, {'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'timeFrame': 'Baseline, Week 6, Month 4, Month 12, Month 18, Month 24', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). 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': 'Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye', 'timeFrame': 'Baseline, Month 24', '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 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Edema', 'Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '27286894', 'type': 'DERIVED', 'citation': 'Korobelnik JF, Kodjikian L, Delcourt C, Gualino V, Leaback R, Pinchinat S, Velard ME. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2307-2318. doi: 10.1007/s00417-016-3394-y. Epub 2016 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Macular Oedema due to Retinal Vein Occlusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular oedema due to retinal vein occlusion\n\nExclusion Criteria:\n\n* Not living in metropolitan France'}, 'identificationModule': {'nctId': 'NCT01618266', 'briefTitle': 'Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF/AGN/OPH/RET/009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ozurdex® (dexamethasone intravitreal implant)', 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.', 'interventionNames': ['Drug: dexamethasone intravitreal implant']}], 'interventions': [{'name': 'dexamethasone intravitreal implant', 'type': 'DRUG', 'otherNames': ['Ozurdex®'], 'description': 'dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.', 'armGroupLabels': ['Ozurdex® (dexamethasone intravitreal implant)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}