Recruiting

Observational Study

Sponsor:

Jaeb Center for Health Research

Code:

NCT07270133

Conditions

Diabetic Retinal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visual Acuity

Reading Speed

Visual Field testing

Contrast sensitivity

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

Study Details

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.

Conditions

Diabetic Retinal Disease

Study ID

NCT07270133

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-diabetic controls

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

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 Acuity

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

Reading Speed

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

Visual Field testing

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.

Contrast sensitivity

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.).

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

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

Ultrawide field-color photograph

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)

Ultrawide field-Fluorescein angiogram

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

Optical coherence tomography

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

Optical coherence tomography- Angiography

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.

Primary outcome measure

  • Does the performance of the objectiveFIELD Analyzer at baseline worsen as the Diabetic Retinopathy Severity Score increases [ Time Frame: 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 ]
  • Does the performance of the Electroretinography (ERG) at baseline worsen as the Diabetic Retinopathy Severity Score increases [ Time Frame: 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 ]
  • Does the performance of the Ultrawide field-Fluorescein angiogram at baseline worsen as the Diabetic Retinopathy Severity Score increases [ Time Frame: 4 Years ]
  • Does the performance of the Optical coherence tomography at baseline worsen as the Diabetic Retinopathy Severity Score increases [ Time Frame: 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 ]
  • Does the performance of Visual Acuity at baseline worsen as the Diabetic Retinopathy Severity Score increases [ Time Frame: 4 Years ]

Central Contacts and Locations

Locations

Retina Associates of Southern California

Recruiting

Huntington Beach, California, United States, 92647

Contacts

Hani Salehi-Had, MD

657-227-9496i.gomez@retinasocal.com

Southeast Retina Center, P.C.

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Dennis M Marcus, MD

709-650-0061amitchell@southeastretina.com

Boston Medical Center Corporation

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Steven D Ness, MD

617-414-4020sreevardhan.alluri@bmc.org

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Paul A Edwards, MD

313-874-9167mthoma22@hfhs.org

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Andrew J. Barkmeier, MD

507-538-8119Taylor.Laura2@mayo.edu

Retina-Vitreous Consultants, Inc.

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Shripaad Y Shukla, MD

412-683-5300merlottil@retinapittsburgh.com

Pittsburgh Clinical Trial Consortium

Recruiting

Sewickley, Pennsylvania, United States, 15143

Contacts

Leanne T. Labriola, DO, MBA

412-301-5326franco@pghtrials.com

Retina Consultants of Texas

Recruiting

Beaumont, Texas, United States, 77707

Contacts

William Pearce, MD

9008335921alaida.jimenez@retinaconsultantstexas.com

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Oct 23, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.