Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes (AR)
March 26, 2026 updated by: Jaeb Center for Health Research
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
- 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
Study Type
Observational
Enrollment (Estimated)
450
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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
Description
Key Inclusion Criteria:
- Age ≥ 18 years
- Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients
- Best corrected visual acuity 20/32 or better (Snellen) (≥74 ETDRS letters)
- Meets criteria for one of the defined observational groups below
- Able and willing to provide informed consent
Key Exclusion Criteria:
- 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
- Previous treatment of any kind for diabetic retinopathy or DME
- Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
- History of rhegmatogenous retinal detachment or macular hole
- History of vitrectomy
- Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
- Requiring treatment for DR/DME in the next 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-diabetic controls
Aged-matched people without a diagnosis of diabetes.
At least one eye must be eligible without retinal pathology.
|
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
Other Names:
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
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.
Other Names:
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.).
Other Names:
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
Other Names:
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)
Other Names:
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
Other Names:
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
Other Names:
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.
Other Names:
|
|
Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)
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
|
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
Other Names:
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
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.
Other Names:
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.).
Other Names:
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
Other Names:
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)
Other Names:
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
Other Names:
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
Other Names:
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.
Other Names:
|
|
Minimal to Mild non-proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 20-35, and no center-involved diabetic macular edema
|
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
Other Names:
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
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.
Other Names:
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.).
Other Names:
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
Other Names:
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)
Other Names:
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
Other Names:
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
Other Names:
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.
Other Names:
|
|
Moderate non-proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 43-47, and no center-involved diabetic macular edema
|
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
Other Names:
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
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.
Other Names:
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.).
Other Names:
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
Other Names:
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)
Other Names:
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
Other Names:
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
Other Names:
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.
Other Names:
|
|
Severe non-proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 53, and no center-involved diabetic macular edema
|
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
Other Names:
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
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.
Other Names:
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.).
Other Names:
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
Other Names:
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)
Other Names:
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
Other Names:
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
Other Names:
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.
Other Names:
|
|
Proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale > 60, and no center-involved diabetic macular edema
|
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
Other Names:
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
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.
Other Names:
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.).
Other Names:
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
Other Names:
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)
Other Names:
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
Other Names:
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
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does the performance of the objectiveFIELD Analyzer at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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.
|
4 Years
|
|
Does the performance of the Contrast sensitivity (AST Manifold qCSF) at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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.).
|
4 Years
|
|
Does the performance of the Electroretinography (ERG) at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device.
It enables clinicians to assess the retinal and optic nerve.
|
4 Years
|
|
Does the performance of the Ultrawide field-color photograph at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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)
|
4 Years
|
|
Does the performance of the Ultrawide field-Fluorescein angiogram at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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
|
4 Years
|
|
Does the performance of the Optical coherence tomography at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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
|
4 Years
|
|
Does the performance of the Optical Coherence Tomography- Angiography at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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.
|
4 Years
|
|
Does the performance of Visual Acuity at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
|
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
|
4 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 2, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2032
Study Registration Dates
First Submitted
October 7, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Physical Phenomena
- Tomography
- Diagnostic Imaging
- Electromagnetic Phenomena
- Magnetic Phenomena
- Tomography, Optical
- Optical Imaging
- Electromagnetic Radiation
- Radiation
- Optical Phenomena
- Radiation, Nonionizing
- Electrodiagnosis
- Diagnostic Techniques, Ophthalmological
- Ocular Physiological Phenomena
- Vision Tests
- Tomography, Optical Coherence
- Visual Acuity
- Visual Fields
- Light
- Contrast Sensitivity
- Electroretinography
Other Study ID Numbers
- Protocol AR
- UG1EY014231 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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