Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT01951066
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2013-09-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Diabetic Macular Edema Treated With Ozurdex (DMEO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pcampo@jhmi.edu', 'phone': '(410) 955-5106', 'title': '[Peter A. Campochiaro', 'organization': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'otherNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Steroid injection in the hip due to arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Racing of heart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Foot Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Vision loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Patient had a fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Increased Intraocular pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Eye soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Bruising of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Blood transfusion due to severe anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Cataract progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Emergency room visit because of a possible seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Mitral valve repair surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Implant', 'description': 'Patients received an injection of an dexamethasone implant'}, {'id': 'OG001', 'title': 'Anti-VEGF Agent', 'description': 'Patients received PRN injections of an Anti-VEGF agent'}], 'classes': [{'title': 'IGF-BP1', 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000'}, {'value': '0.059', 'groupId': 'OG001'}]}]}, {'title': 'Prolactin', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000'}, {'value': '0.369', 'groupId': 'OG001'}]}]}, {'title': 'MMP-9', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000'}, {'value': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'EG-VEGF', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000'}, {'value': '-0.004', 'groupId': 'OG001'}]}]}, {'title': 'Endostatin', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}, {'value': '0.189', 'groupId': 'OG001'}]}]}, {'title': 'Angiopoietin-2', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}, {'value': '0.229', 'groupId': 'OG001'}]}]}, {'title': 'IGF-BP3', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000'}, {'value': '0.435', 'groupId': 'OG001'}]}]}, {'title': 'Persephin', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}, {'value': '0.114', 'groupId': 'OG001'}]}]}, {'title': 'MIP-1a', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}, {'value': '-0.107', 'groupId': 'OG001'}]}]}, {'title': 'THSP-2', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.064', 'groupId': 'OG001'}]}]}, {'title': 'HGF', 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000'}, {'value': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000'}, {'value': '-0.184', 'groupId': 'OG001'}]}]}, {'title': 'CXCL16', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000'}, {'value': '0.027', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent', 'description': 'Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).', 'unitOfMeasure': 'Pearson correlation coefficient (r)', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (Dexamethasone Implant/Anti-VEGF)', 'description': 'Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.\n\nDexamethasone Implant: Patients will receive a single injection of a dexmethasone implant\n\nAnti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent'}, {'id': 'FG001', 'title': 'Group 2 (Anti-VEGF/Dexamethasone Implant)', 'description': 'Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.\n\nDexamethasone Implant: Patients will receive a single injection of a dexmethasone implant\n\nAnti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent'}], 'periods': [{'title': 'First Intervention (Baseline to Week 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Week 16 to Week 32)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Intraretinal Fluid', 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean Disease Duration', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '132'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prior Anti-VEGF injections', 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '56'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Injections', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prior Intraocular Steroids', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Laser', 'classes': [{'title': 'Grid Laser', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Scatter Laser Photocoagulation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Best Corrected Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'description': 'The Best Corrected Visual Acuity (BCVA) was measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Score. Patient can have an ETDRS score ranging from 5 to 100. A higher ETDRS Score represents better visual acuity.', 'unitOfMeasure': 'ETDRS Score', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline Central Subfield Thickness', 'classes': [{'categories': [{'measurements': [{'value': '464.3', 'groupId': 'BG000', 'lowerLimit': '280', 'upperLimit': '779'}]}]}], 'paramType': 'MEAN', 'description': 'The Central Subfield Thickness (CST) was measured using Spectralis OCT machine.', 'unitOfMeasure': 'Microns', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2013-09-20', 'resultsFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-20', 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent', 'timeFrame': '1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent', 'description': 'Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema', 'detailedDescription': 'Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.\n\nOur primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Signed informed consent and authorization of use and disclosure of protected health information\n\n * Age more than or equal to 18 years\n * Diagnosis of diabetic macular edema\n * Intraretinal or subretinal fluid in the macula determined by Spectralis OCT\n * Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)\n * In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision\n * Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent\n\nExclusion Criteria:\n\n* • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye\n\n * Intraocular surgery in the study eye within 3 months of study entry\n * Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry\n * Previous use of an anti-VEGF drug within 1 month of study entry\n * Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry\n * Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.\n * Inability to comply with study or follow up procedures\n * History of glaucoma. (Patients who have undergone filtration surgery may be included)\n * Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.\n * Aphakic eyes with rupture of the posterior lens capsule.\n * Eyes with ACIOL and rupture of the posterior lens capsule.\n * Patients with hypersensitivity to dexamethasone or to any other components of the product'}, 'identificationModule': {'nctId': 'NCT01951066', 'acronym': 'DMEO', 'briefTitle': 'Diabetic Macular Edema Treated With Ozurdex (DMEO)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Diabetic Macular Edema Treated With Ozurdex (DMEO)', 'orgStudyIdInfo': {'id': 'DMEO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (dexamethasone implant/anti-VEGF)', 'description': 'Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.', 'interventionNames': ['Drug: Dexamethasone Implant', 'Drug: Anti-VEGF injection']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (anti-VEGF/dexamethasone implant)', 'description': 'Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.', 'interventionNames': ['Drug: Dexamethasone Implant', 'Drug: Anti-VEGF injection']}], 'interventions': [{'name': 'Dexamethasone Implant', 'type': 'DRUG', 'description': 'Patients will receive a single injection of a dexmethasone implant', 'armGroupLabels': ['Group 1 (dexamethasone implant/anti-VEGF)', 'Group 2 (anti-VEGF/dexamethasone implant)']}, {'name': 'Anti-VEGF injection', 'type': 'DRUG', 'description': 'Patients will receive PRN injections of an anti-VEGF agent', 'armGroupLabels': ['Group 1 (dexamethasone implant/anti-VEGF)', 'Group 2 (anti-VEGF/dexamethasone implant)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Peter A Campochiaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology and Neuroscience', 'investigatorFullName': 'Peter A Campochiaro, MD', 'investigatorAffiliation': 'Johns Hopkins University'}}}}