Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-01 @ 9:34 AM
Study NCT ID:
NCT00886392
Status:
COMPLETED
Last Update Posted:
2009-04-22
First Post:
2009-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Macular Edema Severity at Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D008269', 'term': 'Macular Edema'}], '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'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-21', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickening measured by optical coherence tomography in 3 zones: central subfield (when field 1 was thickened), inner ring (when any of fields 2, 3, 4 or 5 was thickened), and inner ring or outer ring (when any of fields 6, 7, 8, or 9 was thickened)', 'timeFrame': 'at the diagnosis moment'}], 'secondaryOutcomes': [{'measure': 'Severity level: adaptation of International clinical diabetic macular edema severity scale to fields of the OCT; mild if thickening exclusively involved outer-ring, moderate if was in inner-ring without involvement field 1, and severe if was in field 1', 'timeFrame': 'at the diagnosis moment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinically Significant Macular Edema', 'Diabetic Macular Edema', 'Optical Coherence Tomography', 'Diabetic Retinopathy', 'Severity'], 'conditions': ['Diabetes Mellitus', 'Diabetic Retinopathy', 'Macular Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the severity level distribution at the moment of diagnosis, in diabetic patients with macular edema from a Mexico City sample, and to identify the rate with severe macular edema that needed immediate treatment.', 'detailedDescription': 'The international severity scale grades macular edema as mild, moderate or severe, according to the distance of the thickening from the center of the fovea; However, this scale does not define the distances which fulfill the criteria of "distant from" or "approaching" the center of the macula; a quantitative and reproducible tool, such as optical coherence tomography (OCT), could be more accurate to grade severity, by localizing thickening in a standardized way.\n\nAs far as we know, distribution of clinically significant macular edema at the moment of diagnosis, according to the international scale has not been described. A study was conducted to identify the rate of eyes that had severe macular edema at the moment of diagnosis, whose risk of visual loss could be higher and required immediate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Target population were type 2 diabetic patients with CSME who attended general hospitals of Mexico City and its metropolitan area; available population were patients with CSME evaluated at a general hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetic\n* regardless of diabetes duration and retinopathy severity level\n* one or both eyes with CSME\n\nExclusion Criteria:\n\n* media opacities that prevented an adequate fast macular map from being acquired\n* a thickened posterior vitreous\n* any additional retinal disease'}, 'identificationModule': {'nctId': 'NCT00886392', 'briefTitle': 'Diabetic Macular Edema Severity at Diagnosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Juarez de Mexico'}, 'officialTitle': 'Distribution of Macular Edema Severity Level at the Moment of Diagnosis', 'orgStudyIdInfo': {'id': 'HJM 1449/08.02.13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic macular edema', 'description': 'Type 2 diabetes patients who had clinically significant macular edema by the criterion of the ETDRS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07760', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Juarez de Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Patricia Muñoz Ibarra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Juarez de Mexico'}, {'name': 'Dulce M Razo Blanco Hernandez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Juarez de Mexico'}, {'name': 'Virgilio Lima Gomez, MD, MsC', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Juarez de Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Juarez de Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Virgilio Lima Gomez', 'oldOrganization': 'Hospital Juarez de Mexico'}}}}