Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-20 @ 6:27 AM
Study NCT ID:
NCT03922932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WF and PR OCTA in Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PR-OCTA Measure of Non-Perfusion Areas', 'timeFrame': '3 years', 'description': 'Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.'}, {'measure': 'Non-PR-OCTA Measure of Retinal Non-Perfusion Areas', 'timeFrame': '1 year', 'description': 'Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.'}, {'measure': 'Non-PR-OCTA Retinal Neovascularization Areas', 'timeFrame': '1 year', 'description': 'Retinal neovascularization areas will be measured in mm2.'}, {'measure': 'Structural OCT Cyst Volume', 'timeFrame': '1 year', 'description': 'Cyst volume will be measured in mm3.'}, {'measure': 'Structural OCT Retinal Thickening Area', 'timeFrame': '1 year', 'description': 'The area of retinal thickening will be measured in mm2.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'OCT', 'Angiography', 'Diabetic retinopathy'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults age 18 or older with either healthy eyes or diabetic retinopathy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participant-Related Inclusion Criteria:\n\nI. All Diabetics (Groups A, B, C)\n\n* Type 1 diabetes of at least 5 years duration or\n* Type 2 diabetes of any duration II. Group B\n* Able to return for follow-up over 3 years\n\nParticipant-Related Exclusion Criteria:\n\nI. Group B\n\n* Significant medical condition that would make long-term follow-up difficult II. Controls (Group D)\n* Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.)\n\nEye-Related Inclusion Criteria:\n\nI. Group A:\n\n* Presence of active neovascularization, with or without prior treatment\n* Presence of involuted fibrovascular proliferans\n\nII. Group B:\n\n* NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale\n\nIII. Groups C \\& D:\n\n* No evidence of diabetic retinopathy\n\nIV. Group ME:\n\n* Presence of center-involving macular edema requiring treatment\n\nEye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)\n\n* Visual acuity worse than 20/200\n* Inability to maintain stable fixation for OCT imaging\n* History of major eye surgery (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery, etc.) within 90 days of enrollment\n* History of another eye disease or condition that may alter retinal perfusion, permeability, or retinal anatomy\n* Substantial media opacity (cataract, corneal scar, vitreous hemorrhage) that may interfere with study imaging'}, 'identificationModule': {'nctId': 'NCT03922932', 'briefTitle': 'WF and PR OCTA in Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'OHSU IRB#00016932'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A: PDR', 'description': 'This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR.'}, {'label': 'Group B: NPDR', 'description': 'This group will consist of 60 subjects with severe non-proliferative diabetic retinopathy (NPDR), 60 subjects with moderate NPDR, and 60 subjects with mild NPDR.'}, {'label': 'Group ME: Macular Edema', 'description': 'This group is a sub-set of 25 subjects from either Group A or B who have macular edema requiring treatment.'}, {'label': 'Group C: DM without Retinopathy', 'description': 'This group will consist of 60 subjects with diabetes mellitus (DM) who do not have retinopathy.'}, {'label': 'Group D: Healthy Controls', 'description': 'This group will consist of 50 subjects with healthy eyes who do not have diabetes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Thomas Hwang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Thomas Hwang, MD, Associate Professor of Ophthalmology', 'investigatorFullName': 'David Huang', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}