Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for all trials

Timeline

80mo left

Started May 2026

Longer than P75 for all trials

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.6 years study duration

First Submitted

Initial submission to the registry

October 7, 2025

Completed

2 months until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed

5 months until next milestone

Study Start

First participant enrolled

May 2, 2026

Expected

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

October 7, 2025

Last Update Submit

March 26, 2026

Conditions

Diabetic Retinal Disease

Outcome Measures

Primary Outcomes (8)

Does the performance of the objectiveFIELD Analyzer at baseline worsen as the Diabetic Retinopathy Severity Score increases
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
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
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
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
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
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
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
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

Study Arms (6)

Non-diabetic controls

Aged-matched people without a diagnosis of diabetes. At least one eye must be eligible without retinal pathology.

Diagnostic Test: Visual AcuityDiagnostic Test: Reading SpeedDiagnostic Test: Visual Field testingDiagnostic Test: Contrast sensitivityDiagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted statesDiagnostic Test: Ultrawide field-color photographDiagnostic Test: Ultrawide field-Fluorescein angiogramDiagnostic Test: Optical coherence tomographyOther: Optical coherence tomography- Angiography

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

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

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

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

Proliferative diabetic retinopathy

Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale \> 60, and no center-involved diabetic macular edema

Interventions

Visual AcuityDIAGNOSTIC_TEST

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

Also known as: Early treatment diabetic retinopathy study visual acuity ETDRS

Minimal to Mild non-proliferative diabetic retinopathyModerate non-proliferative diabetic retinopathyNon-diabetic controlsProliferative diabetic retinopathySevere non-proliferative diabetic retinopathySubclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)

Reading SpeedDIAGNOSTIC_TEST

The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.

Also known as: MNREAD (Minnesota Low-Vision Reading)

Visual Field testingDIAGNOSTIC_TEST

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.

Also known as: objectiveFIELD analyzer

Contrast sensitivityDIAGNOSTIC_TEST

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.).

Also known as: AST Manifold qCSF

Ultrawide field-color photographDIAGNOSTIC_TEST

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)

Also known as: UWF-Photo

Ultrawide field-Fluorescein angiogramDIAGNOSTIC_TEST

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

Also known as: UWF-FA

Optical coherence tomographyDIAGNOSTIC_TEST

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

Also known as: OCT

Optical coherence tomography- AngiographyOTHER

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.

Also known as: OCT-A

Electroretinography (ERG) and pupillography in light- and dark-adapted statesDIAGNOSTIC_TEST

The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.

Also known as: RETeval device

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Jaeb Center for Health Researchlead
National Eye Institute (NEI)collaborator

MeSH Terms

Interventions

Visual AcuityVisual FieldsContrast SensitivityElectroretinographyLightTomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological PhenomenaElectrodiagnosisElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, NonionizingTomography, OpticalOptical ImagingDiagnostic ImagingTomographyInvestigative Techniques

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 7, 2025

First Posted

December 8, 2025

Study Start (Estimated)

May 2, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2032

Last Updated

April 1, 2026

Record last verified: 2026-03

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Study Arms (6)

Non-diabetic controls

Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)

Minimal to Mild non-proliferative diabetic retinopathy

Moderate non-proliferative diabetic retinopathy

Severe non-proliferative diabetic retinopathy

Proliferative diabetic retinopathy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates