Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01295112
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2011-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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'}, {'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'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tclemons@emmes.com', 'phone': '1-301-251-1161', 'title': 'Traci Clemons', 'phoneExt': '10212', 'organization': 'The Emmes Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations of this study included the relatively small size of 68 eyes, however statistical analyses were robust. The sample size was small due to the disease of study being a rare disease of study so the sample size is limited.'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Active bevacizumab (Avastin®) and Sham Ozurdex®\n\nActive bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Active bevacizumab (Avastin®) and Active Ozurdex®\n\nActive bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Active bevacizumab (Avastin®) and Sham Ozurdex®\n\nActive bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Active bevacizumab (Avastin®) and Active Ozurdex®\n\nActive bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose'}], 'classes': [{'categories': [{'title': '0 PRN Injections', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': '1 PRN Injection', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '2 PRN Injections', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '3 PRN Injections', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '4 PRN Injections', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.00002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Active bevacizumab (Avastin®) and Sham Ozurdex®\n\nActive bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Active bevacizumab (Avastin®) and Active Ozurdex®\n\nActive bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '16.20', 'spread': '15.49', 'groupId': 'OG000'}, {'value': '13.55', 'spread': '19.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.51', 'ciLowerLimit': '-4.43', 'ciUpperLimit': '9.74', 'pValueComment': 'The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.96', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Active bevacizumab (Avastin®) and Sham Ozurdex®\n\nActive bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Active bevacizumab (Avastin®) and Active Ozurdex®\n\nActive bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 68 participants ≥18 years of age with a diagnosis of central retinal vein occlusion (CRVO) as determined by fundus photography and fluorescein angiography were enrolled in the study at 5 clinical centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Active bevacizumab (Avastin®) and Sham Ozurdex®\n\nActive bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Active bevacizumab (Avastin®) and Active Ozurdex®\n\nActive bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Injections', 'classes': [{'categories': [{'title': 'Bevacizumab', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'No Injection', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Ranibizumab', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Bevacizumab and Ranibizumab', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Bevacizumab and Aflibercept', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Eye', 'classes': [{'categories': [{'title': 'Right Eye', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Left Eye', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline best corrected visual acuity (BCVA) in Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '18.2', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '17.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Best corrected visual acuity (BCVA): best possible vision a person can achieve with corrective lenses, measured using the method from the early treatment for diabetic retinopathy study (ETDRS) protocol. BCVA ranges from 0 to 100.', 'unitOfMeasure': 'letters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baselinen best corrected visual acuity (BCVA) in Fellow Eye', 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '82.2', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '82.1', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Best corrected visual acuity (BCVA): best possible vision a person can achieve with corrective lenses, measured using the method from the early treatment for diabetic retinopathy study (ETDRS) protocol. BCVA ranges from 0 to 100.', 'unitOfMeasure': 'letters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Central Foveal Thickness in Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '264.5', 'spread': '68.9', 'groupId': 'BG000'}, {'value': '262.1', 'spread': '70.0', 'groupId': 'BG001'}, {'value': '263.3', 'spread': '68.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Central Foveal Thickness in Fellow Eye', 'classes': [{'categories': [{'measurements': [{'value': '209.3', 'spread': '39.1', 'groupId': 'BG000'}, {'value': '213.1', 'spread': '35.6', 'groupId': 'BG001'}, {'value': '211.2', 'spread': '36.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2011-02-10', 'resultsFirstSubmitDate': '2017-08-03', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2017-09-17', 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24', 'timeFrame': '24 weeks', 'description': 'The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Ischemic Central Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.', 'detailedDescription': 'This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male or female subjects (aged 18 or older);\n2. provide written informed consent and sign/date a health information release;\n3. women of childbearing potential must be willing to practice effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n1. any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results;\n2. use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed);\n3. sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1);\n4. use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study;\n5. known allergy or hypersensitivity to the study medications or their components;\n6. previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.'}, 'identificationModule': {'nctId': 'NCT01295112', 'briefTitle': 'Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Texas Retina Associates'}, 'officialTitle': 'Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': 'TRA-OZAB-11-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group 1', 'description': 'Active bevacizumab (Avastin®) and Sham Ozurdex®', 'interventionNames': ['Drug: Active bevacizumab and Sham dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Active bevacizumab (Avastin®) and Active Ozurdex®', 'interventionNames': ['Drug: Active bevacizumab and Active dexamethasone']}], 'interventions': [{'name': 'Active bevacizumab and Sham dexamethasone', 'type': 'DRUG', 'otherNames': ['Avastin® (bevacizumab)', 'Ozurdex® (dexamethasone intravitreal implant)'], 'description': 'Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe', 'armGroupLabels': ['Group 1']}, {'name': 'Active bevacizumab and Active dexamethasone', 'type': 'DRUG', 'otherNames': ['Avastin® (bevacizumab)', 'Ozurdex® (dexamethasone intravitreal implant)'], 'description': 'Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Karl Csaky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Retina Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Retina Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}