Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT01934920
Status:
UNKNOWN
Last Update Posted:
2019-02-07
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Patients With Unrecognized Treatable Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the incidence of new and/or undiagnosed diabetic macular edema.', 'timeFrame': '1 day (Patients are only seen once for assessments)', 'description': 'This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography'}], 'secondaryOutcomes': [{'measure': 'Streamlining and identification of patients at risk of diabetic macular edema', 'timeFrame': '1 day (Patients only seen once for assessments)', 'description': 'Establish methods for streamlining screening and identification of patients at risk.\n\nEstablish methods for referral for treatment of patients identified with vision threatening diabetic retinopathy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients identified through medical records or admitted into Franklin Square Hospital with a history of diabetes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study\n* Age \\> 18 years\n* Patient related considerations\n* Patients with diabetes mellitus\n* Disease related considerations\n* Diabetes mellitus\n\nExclusion Criteria:\n\n* Prior admission screening within twelve months.\n* Inability to sit for evaluation'}, 'identificationModule': {'nctId': 'NCT01934920', 'briefTitle': 'Identifying Patients With Unrecognized Treatable Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Elman Retina Group'}, 'officialTitle': 'Identifying Patients With Unrecognized Treatable Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'Elman-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Belz', 'role': 'CONTACT', 'email': 'belz@elmanretina.com', 'phone': '410-686-3000'}, {'name': 'Michael Elman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aaron Goldberg, Primary Care', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael J Elman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Jennifer Belz', 'role': 'CONTACT', 'email': 'belz@elmanretina.com', 'phone': '4106863000'}], 'overallOfficials': [{'name': 'Michael J Elman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elman Retina Group, P.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elman Retina Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}