Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
Study NCT ID:
NCT03765112
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2018-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perfusion density', 'timeFrame': '6 months', 'description': 'The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.'}], 'secondaryOutcomes': [{'measure': 'Areas of different perfusion density', 'timeFrame': '6 months', 'description': 'Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient'}, {'measure': 'Foveal avascular zone (FAZ)', 'timeFrame': '6 months', 'description': 'Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.'}, {'measure': 'Foveal avascular zone (FAZ)', 'timeFrame': '6 months', 'description': 'The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.'}, {'measure': 'Presence of predominantly peripheral lesions (PPL)', 'timeFrame': '6 months', 'description': 'The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA'}, {'measure': 'Retinal layer thickness', 'timeFrame': '6 months', 'description': 'Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA'}, {'measure': 'Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year', 'timeFrame': '18 months', 'description': 'Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '32392316', 'type': 'DERIVED', 'citation': 'Karst SG, Heisler M, Lo J, Schuck N, Safari A, V Sarunic M, Maberley DAL, Navajas EV. Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):8. doi: 10.1167/iovs.61.5.8.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.', 'detailedDescription': 'The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.\n\nImaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 Participants can have 1 or 2 study eyes\n\nPatient Group:\n\n* Diabetes mellitus type 1 or 2\n* Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR\n\nExclusion Criteria:\n\n* Substantial media opacities that would preclude successful imaging\n\n * Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye\n * Structural damage to the center of macula in the study eye\n * History of prior panretinal photocoagulation\n * History of treatment with intravitreal agents over the prior 6 months\n * Macular edema involving the central subfield\n * Prior history of vitrectomy\n * Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques\n * Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies\n * Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye\n * Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery\n * Inability to obtain fundus images of sufficient quality to be analyzed and graded'}, 'identificationModule': {'nctId': 'NCT03765112', 'briefTitle': 'Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT', 'orgStudyIdInfo': {'id': 'H18-02095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCTA', 'description': 'Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.', 'interventionNames': ['Device: Optical coherence tomography angiography']}], 'interventions': [{'name': 'Optical coherence tomography angiography', 'type': 'DEVICE', 'description': 'Multiple scans of the retina will be recorded to evaluate microvascular changes.', 'armGroupLabels': ['OCTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 3N9', 'city': 'Vancouver', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Eduardo Navajas, MD', 'role': 'CONTACT', 'email': 'edunavajas@gmail.com', 'phone': '604 875 5475'}, {'name': 'Theresa Wiens, MSc', 'role': 'CONTACT', 'email': 'twiens@eyecarecentre.org', 'phone': '604-875-4111', 'phoneExt': '62544'}, {'name': 'Sonja Karst, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Eye Care Center', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Eduardo Navajas, MD', 'role': 'CONTACT', 'email': 'edunavajas@gmail.com', 'phone': '604 875 5475'}, {'name': 'Theresa Wiens', 'role': 'CONTACT', 'email': 'twiens@eyecarecentre.org', 'phone': '604-875-4111', 'phoneExt': '62544'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eduardo Navajas', 'investigatorAffiliation': 'University of British Columbia'}}}}