Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT03345667
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Color Vision in Diabetic Patients
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'}], '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': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema', 'timeFrame': '3 months', 'description': "Using the Ishihara's test to analise the possible loss of vision"}], 'secondaryOutcomes': [{'measure': 'Frame between the injections', 'timeFrame': '1 months', 'description': 'Ant-Vegf'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinopathy, Diabetic']}, 'descriptionModule': {'briefSummary': 'Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible visual loss.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having diabetic retinopathy with macular edema\n\nExclusion Criteria:\n\n* Not having diabetic retinopathy with macular edema'}, 'identificationModule': {'nctId': 'NCT03345667', 'briefTitle': 'Assessment of Color Vision in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Olhos de Goiania'}, 'officialTitle': 'Assessment of Color Vision in Diabetic Patients Before and After the Use of Anti-vegf in the Treatment of Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'TRABALHO PEDRO ARVO 2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anti-Vegf', 'description': 'Use intravitreous anti-vegf', 'interventionNames': ['Drug: lucentis']}], 'interventions': [{'name': 'lucentis', 'type': 'DRUG', 'description': 'Use of lucentis and other anti-vegf in patients with diabetic retinopathy', 'armGroupLabels': ['Anti-Vegf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74110120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Instituto de Olhos de Goiania', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Olhos de Goiania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}