Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 10:36 PM
Study NCT ID:
NCT04018833
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C533178', 'term': 'aflibercept'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical change', 'timeFrame': 'Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.', 'description': 'The central foveal thickness (CFT), measured by Optical Coherence Tomography, was automatically measured by the software in the central 1 mm. A CFT \\<250 µm or \\>300 µm is considered pathological. A CFT between 200 and 300 µm is considered physiological. CFT has no defined minimum or maximum values.\n\nSince patients with diabetic macular edema usually have CFT \\>300 µm the goal of treatment is to lower the CFT to values between 200 and 300 µm. A clinical significant anatomical improvement was considered for a change in CFT≥10%.'}, {'measure': 'Functional change', 'timeFrame': 'Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.', 'description': 'Functional change was measure by the Early Treatment Diabetic Retinopathy Scale (ETDRS) which measures the best-corrected visual acuity with an ETDRS-like chart at 4 meters in number letters or at 1 meter when patients are unable to read any letters on the ETDRS chart at 4 meters. The ETDRS scale varies from 1 to 85 letters (85 letters correspond to a 20/20 in the Snellen scale).\n\nThe higher the value the better the outcome. A clinical significant functional improvement was considered for a gain of ≥5 EDTRS letters.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic Macular Edema', 'Bevacizumab', 'Ranibizumab', 'Aflibercept', 'BCVA', 'OCT'], 'conditions': ['Diabetic Macular Edema', 'Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '33519187', 'type': 'DERIVED', 'citation': 'Pessoa B, Malheiro L, Carneiro I, Monteiro S, Coelho J, Coelho C, Figueira J, Meireles A, Melo Beirao JN. Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema: Exploratory Retrospective Analysis. Clin Ophthalmol. 2021 Jan 22;15:253-260. doi: 10.2147/OPTH.S280644. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).\n\nMETHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.\n\nA p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients followed on the ocular diabetes consultation of Centro Hospitalar Universitário do Porto, Portugal, with DME unresponsive or incompletly responsive to intravitreal bevacizumab (1,25 MG/0.05 ML).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 1 or type 2 diabetes mellitus patients\n* older than 18 years\n* with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).\n* nonresponsive to bevacizumab, defined as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF\\>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).\n\nExclusion Criteria:\n\n* additional ocular diseases that could significantly affect the visual acuity such as:\n* significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema\n* age-related macular degeneration\n* retinal vascular occlusion\n* central corneal opacity\n* amblyopia\n* advanced glaucoma\n* optic neuropathy\n* history of ocular trauma or surgery other than uncomplicated cataract extraction\n* cataract surgery within 3 months before or after bevacizumab switch\n* unable to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT04018833', 'acronym': 'SWITCH', 'briefTitle': 'Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar do Porto'}, 'officialTitle': 'Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema', 'orgStudyIdInfo': {'id': '20190701245703984'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ranibizumab', 'description': 'Patients nonresponsive to bevacizumab that were switched to ranibizumab', 'interventionNames': ['Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]']}, {'label': 'aflibercept', 'description': 'Patients nonresponsive to bevacizumab that were switched to aflibercept', 'interventionNames': ['Drug: Aflibercept 40 MG/ML Intraocular Solution [EYLEA]']}], 'interventions': [{'name': 'Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]', 'type': 'DRUG', 'armGroupLabels': ['ranibizumab']}, {'name': 'Aflibercept 40 MG/ML Intraocular Solution [EYLEA]', 'type': 'DRUG', 'armGroupLabels': ['aflibercept']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'João Melo-Beirão, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Hospitalar do Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bernardete Pessoa MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist', 'investigatorFullName': 'Bernardete Pessoa MD', 'investigatorAffiliation': 'Centro Hospitalar do Porto'}}}}