Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT07270133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014792', 'term': 'Visual Acuity'}, {'id': 'D014794', 'term': 'Visual Fields'}, {'id': 'D015350', 'term': 'Contrast Sensitivity'}, {'id': 'D004596', 'term': 'Electroretinography'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D014787', 'term': 'Vision Tests'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-10-07', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does the performance of the objectiveFIELD Analyzer at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.'}, {'measure': 'Does the performance of the Contrast sensitivity (AST Manifold qCSF) at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': "A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.)."}, {'measure': 'Does the performance of the Electroretinography (ERG) at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.'}, {'measure': 'Does the performance of the Ultrawide field-color photograph at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)'}, {'measure': 'Does the performance of the Ultrawide field-Fluorescein angiogram at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'A high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment'}, {'measure': 'Does the performance of the Optical coherence tomography at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'A non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression'}, {'measure': 'Does the performance of the Optical Coherence Tomography- Angiography at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'A non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.'}, {'measure': 'Does the performance of Visual Acuity at baseline worsen as the Diabetic Retinopathy Severity Score increases', 'timeFrame': '4 Years', 'description': 'Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \\<20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinal Disease']}, 'descriptionModule': {'briefSummary': 'A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals must meet all of the inclusion criteria and none of the exclusion criteria to be eligible to participate in the study. The potential study participant must have at least one eye meeting the inclusion criteria, but participants may have both eyes eligible for the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients\n* Best corrected visual acuity 20/32 or better (Snellen) (≥74 ETDRS letters)\n* Meets criteria for one of the defined observational groups below\n* Able and willing to provide informed consent\n\nKey Exclusion Criteria:\n\n* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina\n* Previous treatment of any kind for diabetic retinopathy or DME\n* Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)\n* History of rhegmatogenous retinal detachment or macular hole\n* History of vitrectomy\n* Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months\n* Requiring treatment for DR/DME in the next 6 months'}, 'identificationModule': {'nctId': 'NCT07270133', 'acronym': 'AR', 'briefTitle': 'Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes', 'orgStudyIdInfo': {'id': 'Protocol AR'}, 'secondaryIdInfos': [{'id': 'UG1EY014231', 'link': 'https://reporter.nih.gov/quickSearch/UG1EY014231', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-diabetic controls', 'description': 'Aged-matched people without a diagnosis of diabetes. At least one eye must be eligible without retinal pathology.', 'interventionNames': ['Diagnostic Test: Visual Acuity', 'Diagnostic Test: Reading Speed', 'Diagnostic Test: Visual Field testing', 'Diagnostic Test: Contrast sensitivity', 'Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'Diagnostic Test: Ultrawide field-color photograph', 'Diagnostic Test: Ultrawide field-Fluorescein angiogram', 'Diagnostic Test: Optical coherence tomography', 'Other: Optical coherence tomography- Angiography']}, {'label': 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)', 'description': 'Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 10, and no diabetic macular edema. Lower limit on duration of disease for Type 1 is 5 years, for Type 2 is 1 year', 'interventionNames': ['Diagnostic Test: Visual Acuity', 'Diagnostic Test: Reading Speed', 'Diagnostic Test: Visual Field testing', 'Diagnostic Test: Contrast sensitivity', 'Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'Diagnostic Test: Ultrawide field-color photograph', 'Diagnostic Test: Ultrawide field-Fluorescein angiogram', 'Diagnostic Test: Optical coherence tomography', 'Other: Optical coherence tomography- Angiography']}, {'label': 'Minimal to Mild non-proliferative diabetic retinopathy', 'description': 'Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 20-35, and no center-involved diabetic macular edema', 'interventionNames': ['Diagnostic Test: Visual Acuity', 'Diagnostic Test: Reading Speed', 'Diagnostic Test: Visual Field testing', 'Diagnostic Test: Contrast sensitivity', 'Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'Diagnostic Test: Ultrawide field-color photograph', 'Diagnostic Test: Ultrawide field-Fluorescein angiogram', 'Diagnostic Test: Optical coherence tomography', 'Other: Optical coherence tomography- Angiography']}, {'label': 'Moderate non-proliferative diabetic retinopathy', 'description': 'Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 43-47, and no center-involved diabetic macular edema', 'interventionNames': ['Diagnostic Test: Visual Acuity', 'Diagnostic Test: Reading Speed', 'Diagnostic Test: Visual Field testing', 'Diagnostic Test: Contrast sensitivity', 'Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'Diagnostic Test: Ultrawide field-color photograph', 'Diagnostic Test: Ultrawide field-Fluorescein angiogram', 'Diagnostic Test: Optical coherence tomography', 'Other: Optical coherence tomography- Angiography']}, {'label': 'Severe non-proliferative diabetic retinopathy', 'description': 'Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 53, and no center-involved diabetic macular edema', 'interventionNames': ['Diagnostic Test: Visual Acuity', 'Diagnostic Test: Reading Speed', 'Diagnostic Test: Visual Field testing', 'Diagnostic Test: Contrast sensitivity', 'Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'Diagnostic Test: Ultrawide field-color photograph', 'Diagnostic Test: Ultrawide field-Fluorescein angiogram', 'Diagnostic Test: Optical coherence tomography', 'Other: Optical coherence tomography- Angiography']}, {'label': 'Proliferative diabetic retinopathy', 'description': 'Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale \\> 60, and no center-involved diabetic macular edema', 'interventionNames': ['Diagnostic Test: Visual Acuity', 'Diagnostic Test: Reading Speed', 'Diagnostic Test: Visual Field testing', 'Diagnostic Test: Contrast sensitivity', 'Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'Diagnostic Test: Ultrawide field-color photograph', 'Diagnostic Test: Ultrawide field-Fluorescein angiogram', 'Diagnostic Test: Optical coherence tomography', 'Other: Optical coherence tomography- Angiography']}], 'interventions': [{'name': 'Visual Acuity', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Early treatment diabetic retinopathy study visual acuity ETDRS'], 'description': 'Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \\<20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Reading Speed', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MNREAD (Minnesota Low-Vision Reading)'], 'description': 'The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Visual Field testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['objectiveFIELD analyzer'], 'description': 'The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Contrast sensitivity', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['AST Manifold qCSF'], 'description': "A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).", 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Electroretinography (ERG) and pupillography in light- and dark-adapted states', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['RETeval device'], 'description': 'The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Ultrawide field-color photograph', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['UWF-Photo'], 'description': 'Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Ultrawide field-Fluorescein angiogram', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['UWF-FA'], 'description': 'a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Optical coherence tomography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['OCT'], 'description': 'non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}, {'name': 'Optical coherence tomography- Angiography', 'type': 'OTHER', 'otherNames': ['OCT-A'], 'description': 'non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.', 'armGroupLabels': ['Minimal to Mild non-proliferative diabetic retinopathy', 'Moderate non-proliferative diabetic retinopathy', 'Non-diabetic controls', 'Proliferative diabetic retinopathy', 'Severe non-proliferative diabetic retinopathy', 'Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}