Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-29 @ 6:31 PM
Study NCT ID:
NCT04505618
Status:
RECRUITING
Last Update Posted:
2025-06-16
First Post:
2020-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], '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'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D006973', 'term': 'Hypertension'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D007910', 'term': 'Lenses, Intraocular'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1050}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Imaging', 'timeFrame': '5 years', 'description': 'Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy', 'Retinal Vein Occlusion', 'Hypertension,Essential', 'Retinal Vascular Disorder']}, 'descriptionModule': {'briefSummary': 'This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.', 'detailedDescription': 'The objective of this study is to perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.\n\nSubjects will be identified from healthy subjects (seen for screening eye exams) and diseased subjects undergoing standard-of-care treatment or screening at eye clinic locations. The study population will include subjects with retinal vascular disease including but not limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes.\n\nThe study methods will include retrospective review and collection of clinically approved imaging data that is obtained through standard-of-care methods for subjects who meet inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to participate in a prospective study by each clinical study site.\n\nThe study end-points include the correlation of diagnostic imaging findings from Optical Coherence Tomography (OCT) based images with fundus photographs, clinical disease stage and visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* Both subjects with diseases and controls:\n* Children (age\\<18)\n* Pregnant females\n* Developmentally delayed subjects\n* Subjects unable to provide informed consent\n* Inability to cooperate with tests and study instructions\n* Images with motion artifact or signal strength \\< 7\n* History of glaucoma\n* History of age-related macular degeneration\n* History of any visually significant eye disease\n* History of proliferative diabetic retinopathy\n* History of any inflammatory disease\n* History of heart disease\n* History of thyroid disease.\n* Additional criteria for controls:\n* History of any type of Diabetes Mellitus\n* History of any type of Hypertension'}, 'identificationModule': {'nctId': 'NCT04505618', 'acronym': 'OCTA-RVD', 'briefTitle': 'Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease', 'orgStudyIdInfo': {'id': 'IRB00276904'}, 'secondaryIdInfos': [{'id': 'R01EY030564', 'link': 'https://reporter.nih.gov/quickSearch/R01EY030564', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Controls', 'description': 'Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.', 'interventionNames': ['Device: Swept-Source (SS) OCT Angiography', 'Device: Spectral-Domain (SD) OCT Angiography', 'Device: Fundus Imaging', 'Device: Axial Length Measurement Device']}, {'type': 'OTHER', 'label': 'Diabetics with and without Diabetic Retinopathy Only', 'description': 'Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.', 'interventionNames': ['Device: Swept-Source (SS) OCT Angiography', 'Device: Spectral-Domain (SD) OCT Angiography', 'Device: Fundus Imaging', 'Device: Axial Length Measurement Device']}, {'type': 'OTHER', 'label': 'Hypertension Only', 'description': 'Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.', 'interventionNames': ['Device: Swept-Source (SS) OCT Angiography', 'Device: Spectral-Domain (SD) OCT Angiography', 'Device: Fundus Imaging', 'Device: Axial Length Measurement Device']}, {'type': 'OTHER', 'label': 'Diabetics w/ or w/o Diabetic Retinopathy & Hypertension', 'description': 'Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.', 'interventionNames': ['Device: Swept-Source (SS) OCT Angiography', 'Device: Spectral-Domain (SD) OCT Angiography', 'Device: Fundus Imaging', 'Device: Axial Length Measurement Device']}], 'interventions': [{'name': 'Swept-Source (SS) OCT Angiography', 'type': 'DEVICE', 'otherNames': ['SS-OCTA'], 'description': 'Non-invasive, minimal risk, ocular imaging study', 'armGroupLabels': ['Controls', 'Diabetics w/ or w/o Diabetic Retinopathy & Hypertension', 'Diabetics with and without Diabetic Retinopathy Only', 'Hypertension Only']}, {'name': 'Spectral-Domain (SD) OCT Angiography', 'type': 'DEVICE', 'otherNames': ['SD_OCTA'], 'description': 'Non-invasive, minimal risk, ocular imaging study', 'armGroupLabels': ['Controls', 'Diabetics w/ or w/o Diabetic Retinopathy & Hypertension', 'Diabetics with and without Diabetic Retinopathy Only', 'Hypertension Only']}, {'name': 'Fundus Imaging', 'type': 'DEVICE', 'description': 'Non-invasive, minimal risk, ocular imaging study', 'armGroupLabels': ['Controls', 'Diabetics w/ or w/o Diabetic Retinopathy & Hypertension', 'Diabetics with and without Diabetic Retinopathy Only', 'Hypertension Only']}, {'name': 'Axial Length Measurement Device', 'type': 'DEVICE', 'otherNames': ['Intraocular Lens (IOL) Master'], 'description': 'Non-invasive, minimal risk, ocular imaging study', 'armGroupLabels': ['Controls', 'Diabetics w/ or w/o Diabetic Retinopathy & Hypertension', 'Diabetics with and without Diabetic Retinopathy Only', 'Hypertension Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'June Hall', 'role': 'CONTACT', 'email': 'jhall81@jhmi.edu', 'phone': '410-502-2789'}, {'name': 'Ana C Martinez', 'role': 'CONTACT', 'email': 'acollaz5@jhmi.edu'}, {'name': 'Amir H Kashani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Amir H Kashani, MD, PhD', 'role': 'CONTACT', 'email': 'akashan1@jhmi.edu', 'phone': '410-502-2789'}, {'name': 'Ana C Martinez, MPH', 'role': 'CONTACT', 'email': 'acollaz5@jhmi.edu', 'phone': '410-502-2789'}], 'overallOfficials': [{'name': 'Amir Kashani, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}