Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-25 @ 2:18 AM
Study NCT ID:
NCT01571232
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2012-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], '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'}, {'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': 'rongallemoremd@gmail.com', 'phone': '310-944-9393', 'title': 'Ron P. Gallemore M.D., Ph.D.', 'organization': 'Retina Macula Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated Intraocular Pressure', 'notes': 'Greater than 10 mmHg increase in intraocular pressure from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in Visual Acuity (Number of ETDRS Letters).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'OG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Final Visit', 'categories': [{'measurements': [{'value': '69.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The measure the change in ETDRS letters for each treatment group from baseline to 6 months.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Change in Central Foveal Thickness (Microns on High Resolution OCT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'OG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '385.9', 'spread': '43.0', 'groupId': 'OG000'}, {'value': '341.5', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Final Visit', 'categories': [{'measurements': [{'value': '305.4', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '324.3', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The measure the change in central foveal thickness for each treatment group from baseline to 6 months.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Change in Macular Leakage on Fluorescein Angiography From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'OG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}], 'timeFrame': '6 months', 'description': 'To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Fluorescein angiography data were not collected.'}, {'type': 'SECONDARY', 'title': 'The Change in Mean Macular Sensitivity on Microperimetry From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant:\n\nOzurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'OG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Final Visit', 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for two patients due to imaging difficulties.'}, {'type': 'SECONDARY', 'title': 'The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'OG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '11.0', 'groupId': 'OG001'}]}]}, {'title': 'Final Visit', 'categories': [{'measurements': [{'value': '40.9', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.', 'unitOfMeasure': 'nV/deg2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for three other patients due to testing difficulties.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'FG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4\n\ndexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)'}, {'id': 'BG001', 'title': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.\n\nintravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2012-04-02', 'resultsFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-26', 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in Visual Acuity (Number of ETDRS Letters).', 'timeFrame': '6 months', 'description': 'The measure the change in ETDRS letters for each treatment group from baseline to 6 months.'}, {'measure': 'The Change in Central Foveal Thickness (Microns on High Resolution OCT).', 'timeFrame': '6 months', 'description': 'The measure the change in central foveal thickness for each treatment group from baseline to 6 months.'}], 'secondaryOutcomes': [{'measure': 'The Change in Macular Leakage on Fluorescein Angiography From Baseline', 'timeFrame': '6 months', 'description': 'To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.'}, {'measure': 'The Change in Mean Macular Sensitivity on Microperimetry From Baseline', 'timeFrame': '6 months', 'description': 'To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.'}, {'measure': 'The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.', 'timeFrame': '6 months', 'description': 'To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Edema', 'DME', 'PDR', 'NPDR', 'Ozurdex', 'Dexamethasone', 'Avastin', 'Bevacizumab'], 'conditions': ['Diabetic Macular Edema', 'Non-proliferative Diabetic Retinopathy', 'Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.', 'detailedDescription': 'This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of NPDR or PDR as confirmed by fluorescein angiography\n* Prior treatment with \\>= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks\n* \\< 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with \\>= 2 intravitreal anti-VEGF injections\n* Age 18 years or older\n* ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)\n* Ability to provide written informed consent\n* Capable of complying with study protocol.\n\nExclusion Criteria:\n\n* Intraocular injection of steroid medication within prior 3 months\n* Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician\n* Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician\n* Prior vitrectomy surgery\n* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.\n* Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.\n* Patients who are pregnant.\n* Unwilling or unable to follow or comply with all study related procedures'}, 'identificationModule': {'nctId': 'NCT01571232', 'briefTitle': 'Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Retina Macula Institute'}, 'officialTitle': 'Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.', 'orgStudyIdInfo': {'id': 'IIT-406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ozurdex', 'description': 'Patients in this group receive Ozurdex at initial visit and at month 4', 'interventionNames': ['Drug: dexamethasone intravitreal implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin', 'description': 'Patients in this group receive Avastin Q1 month for 5 months.', 'interventionNames': ['Drug: intravitreal bevacizumab']}], 'interventions': [{'name': 'dexamethasone intravitreal implant', 'type': 'DRUG', 'otherNames': ['Ozurdex'], 'description': 'Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)', 'armGroupLabels': ['Ozurdex']}, {'name': 'intravitreal bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.', 'armGroupLabels': ['Avastin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Retina Macula Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'Ron P Gallemore, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Retina Macula Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Macula Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician and CEO of Retina Macula Institute', 'investigatorFullName': 'Ron P. Gallemore', 'investigatorAffiliation': 'Retina Macula Institute'}}}}