Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 8:19 AM
Study NCT ID:
NCT01787669
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2013-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean change in BCVA (best corrected visual acuity)', 'timeFrame': '6 months', 'description': 'Proportion of eyes with a gain of 15 LogMAR letters or more\n\n* Proportion of eyes with a loss of less than 15 LogMAR letters\n* Proportion of eyes with gain of 5 LogMAR letters or more\n* Proportion of eyes with gain of 10 LogMAR letters or more'}], 'primaryOutcomes': [{'measure': 'Proportion of eyes that have central macular thickness <300 microns 6 months after switching', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Mean change in central macular thickness (CMT) as measured by OCT.', 'timeFrame': '6 months', 'description': 'Mean change in central macular thickness (CMT) as measured by OCT.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic macular oedema', 'diabetic macular edema', 'diabetic retinopathy', 'dexamethasone', 'Ozurdex', 'Avastin', 'bevacizumab', 'DME', 'DMO'], 'conditions': ['Diabetes', 'Diabetic Macular Oedema', 'Diabetic Macular Edema', 'Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The specific aim of the study is to test the following hypothesis:\n\nThat switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with diabetic macular oedema with no or incomplete response from one therapy is beneficial.', 'detailedDescription': 'A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEyes Previously Treated with bevacizumab:\n\n1. Diabetic macular oedema affecting the fovea that has persisted despite ongoing, monthly intravitreal injections of bevacizumab over at least 6 months, the last being 2 to 3 months prior to the screening visit.\n2. There must be an historical OCT available from 1-4 weeks after the last bevacizumab injection with retinal thickness \\> 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to bevacizumab.\n3. At screening, the bevacizumab treated eye must have DMO with retinal thickness \\> 300 microns in the central 1mm subfield on Spectral domain OCT\n\n Eyes Previously Treated with dexamethasone:\n4. Diabetic macular oedema affecting the fovea that has persisted despite two dexamethasone implants 5 or fewer months apart, the last being 5-8 months prior to the screening visit.\n5. There must be an historical OCT available from 8-14 weeks after the last dexamethasone implant with retinal thickness \\> 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to the dexamethasone implant.\n6. At screening, the dexamethasone treated eye must have DMO with retinal thickness \\> 300 microns in central 1mm subfield on Spectral domain OCT\n7. Age \\>= 18 years\n8. Diagnosis of diabetes mellitus\n9. Best corrected visual acuity of 20-78 letters (approx 6/120 -6/7.5)\n10. Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful\n11. Intraocular pressure \\<22mmHg\n12. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised\n13. Written informed consent has been obtained.\n\nExclusion Criteria:\n\n* Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar TA within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.\n* Cataract surgery within the last 3 months\n* Retinal laser treatment within the last 3 months\n* For eyes to be switched to Dexamethasone: Patient considered, at the judgement of the investigator, to be at-risk for syphilis, tuberculosis or other potentially infective chorioretinopathies. Patients considered at-risk may be assessed at the investigators discretion to reasonably exclude these conditions. Should these conditions be excluded, the patient may be considered for enrolment.'}, 'identificationModule': {'nctId': 'NCT01787669', 'acronym': 'SwitchDMO', 'briefTitle': 'Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)', 'orgStudyIdInfo': {'id': 'SwitchDMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin (bevacizumab)', 'description': 'Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria', 'interventionNames': ['Drug: Avastin (Bevacizumab)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ozurdex (dexamethasone)', 'description': 'single dose at baseline and repeat dose when required according to defined re-treatment criteria', 'interventionNames': ['Drug: Ozurdex (dexamethasone)']}], 'interventions': [{'name': 'Avastin (Bevacizumab)', 'type': 'DRUG', 'description': 'Avastin (Bevacizumab) administered intravitreally', 'armGroupLabels': ['Avastin (bevacizumab)']}, {'name': 'Ozurdex (dexamethasone)', 'type': 'DRUG', 'description': 'Ozurdex (dexamethasone) given intravitreally', 'armGroupLabels': ['Ozurdex (dexamethasone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Eye Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Lions Eye Institute', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Samantha FRASER-BELL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}