Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT01231633
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2010-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
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': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'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'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vaderamo@gmail.com', 'phone': '5164660390', 'title': 'Vincent A. Deramo, MD', 'phoneExt': '222', 'organization': 'Long Island Vitreoretinal Consultants'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected for the study period of 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.\n\nOzurdex: Ozurdex, 0.7mg dexamethasone\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.\n\nOzurdex: Ozurdex, 0.7mg dexamethasone\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '38'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - Month 6', 'description': 'The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm', 'unitOfMeasure': 'Letters Gain/Loss', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex & Avastin', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.\n\nOzurdex: Ozurdex, 0.7mg dexamethasone\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}, {'id': 'OG001', 'title': 'Avastin Only', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - Month 6', 'description': 'Total Number of addiitonal Avastin injections during study- From baseline to Month 6', 'unitOfMeasure': 'Injections', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Central Mean Thickness Based on OCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.\n\nOzurdex: Ozurdex, 0.7mg dexamethasone\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}], 'classes': [{'title': 'Initial OCT Measure at Basline', 'categories': [{'measurements': [{'value': '703', 'groupId': 'OG000', 'lowerLimit': '344', 'upperLimit': '1255'}, {'value': '790', 'groupId': 'OG001', 'lowerLimit': '496', 'upperLimit': '1183'}]}]}, {'title': 'Final OCT measure at Month 6', 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000', 'lowerLimit': '189', 'upperLimit': '605'}, {'value': '408', 'groupId': 'OG001', 'lowerLimit': '149', 'upperLimit': '710'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 Months', 'description': 'Change in Central Mean Thickness based on OCT from baseline to Month 6t', 'unitOfMeasure': 'Microns on OCT', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ozurdex & Avastin', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.\n\nOzurdex: Ozurdex, 0.7mg dexamethasone\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}, {'id': 'FG001', 'title': 'Avastin Only', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.\n\nOzurdex: Ozurdex, 0.7mg dexamethasone\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.\n\nAvastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '92'}, {'value': '74.3', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '86'}, {'value': '71.3', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2010-10-28', 'resultsFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2010-10-29', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-05', 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm', 'timeFrame': 'Baseline - Month 6', 'description': 'The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm'}, {'measure': 'The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm', 'timeFrame': 'Baseline - Month 6', 'description': 'Total Number of addiitonal Avastin injections during study- From baseline to Month 6'}], 'secondaryOutcomes': [{'measure': 'Change in Central Mean Thickness Based on OCT', 'timeFrame': 'Baseline to 6 Months', 'description': 'Change in Central Mean Thickness based on OCT from baseline to Month 6t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Edema', 'Central Retinal Vein Occlusion'], 'conditions': ['Macular Edema', 'Central Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of central retinal vein occlusion (CRVO)\n* Age 18 years or older\n* ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800\n* OCT Central foveal thickness \\>250 microns\n* Negative pregnancy test for women of childbearing potential\n* Ability to provide written informed consent\n* Capable of complying with study protocol\n\nExclusion Criteria:\n\n* History of glaucoma in the study eye with intraocular pressure \\>21mmHg on more than one topical medication. Combination drugs are considered more than one medication\n* History of steroid-related glaucoma (steroid response)\n* Previous intraocular injection of steroid medication within 90 days\n* Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days\n* Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician\n* Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days\n* Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician\n* Dense cataract that precludes clinical examination and retinal imaging of the retina\n* History of allergy to dexamethasone, bevacizumab, betadine\n* Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician\n* Unwilling or unable to follow or comply with all study related procedures\n* Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01231633', 'briefTitle': 'Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)', 'organization': {'class': 'OTHER', 'fullName': 'Long Island Vitreoretinal Consultants'}, 'officialTitle': 'Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)', 'orgStudyIdInfo': {'id': 'IST CRVO 1118147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.', 'interventionNames': ['Drug: Ozurdex', 'Drug: Avastin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.', 'interventionNames': ['Drug: Avastin']}], 'interventions': [{'name': 'Ozurdex', 'type': 'DRUG', 'otherNames': ['Dexamethasone implant'], 'description': 'Ozurdex, 0.7mg dexamethasone', 'armGroupLabels': ['Group 1']}, {'name': 'Avastin', 'type': 'DRUG', 'otherNames': ['Avastin, bevacizumab'], 'description': 'Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Vitreous Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Vitreoretinal Consultants', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11788', 'city': 'Hauppauge', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Vitreoretinal Consultants', 'geoPoint': {'lat': 40.82565, 'lon': -73.20261}}, {'zip': '11901', 'city': 'Riverhead', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Vitreoretinal Consultants', 'geoPoint': {'lat': 40.91704, 'lon': -72.66204}}], 'overallOfficials': [{'name': 'Vincent A Deramo, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Long Island Vitreoretinal Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Long Island Vitreoretinal Consultants', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Vincent. A. Deramo, M.D.', 'investigatorAffiliation': 'Long Island Vitreoretinal Consultants'}}}}