Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
Study NCT ID:
NCT04905459
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARDA Software for the Detection of mtmDR
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1012}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images', 'timeFrame': '1 day'}, {'measure': 'Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images', 'timeFrame': '1 day'}, {'measure': 'Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images', 'timeFrame': '1 day'}, {'measure': 'Specificity of ARDA mtmDR for detection of mtmDR in UWF images', 'timeFrame': '1 day'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sites in the U.S.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented diagnosis of Type I or Type II diabetes mellitus:\n\n meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)\n2. Age 22 or older\n3. Understand the study and volunteer to sign the informed consent\n\nExclusion Criteria:\n\n1. Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).\n2. Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.\n3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.\n4. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.\n5. Currently participating in an interventional study.\n6. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).\n7. Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.\n\n 1. Participant is hypersensitive to light (side effect of medication or due to unknown etiology)\n 2. Participant has undergone photodynamic therapy (PDT)\n 3. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).\n8. Known pregnancy or possibility of pregnancy'}, 'identificationModule': {'nctId': 'NCT04905459', 'briefTitle': 'ARDA Software for the Detection of mtmDR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Verily Life Sciences LLC'}, 'officialTitle': 'A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '101703'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retinal Imaging and Mydriatic Agents', 'description': 'Subjects will undergo several types of retinal imaging before and after administration of mydriatic agent. Subjects will be administered mydriatic medication to dilate their pupils.', 'interventionNames': ['Diagnostic Test: ARDA software application']}], 'interventions': [{'name': 'ARDA software application', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subject images will be sent to the investigational ARDA software', 'armGroupLabels': ['Retinal Imaging and Mydriatic Agents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Midwestern University', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '72404', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '61822', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Christie Clinic', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21239', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Health Research Institute Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20737', 'city': 'Riverdale', 'state': 'Maryland', 'country': 'United States', 'facility': 'Riverside Diabetes Clinic', 'geoPoint': {'lat': 39.09928, 'lon': -76.5358}}, {'zip': '49008', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Western Michigan University', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Winston Salem', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Diabetes & Endocrinology Associates of Stark County, Inc', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '74701', 'city': 'Durant', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The Heart and Medical Center, P.C', 'geoPoint': {'lat': 33.99399, 'lon': -96.37082}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'BMG The Endocrine Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials Network', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verily Life Sciences LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Google LLC.', 'class': 'INDUSTRY'}, {'name': 'Optos, PLC', 'class': 'INDUSTRY'}, {'name': 'Nikon Corporation', 'class': 'UNKNOWN'}, {'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}