Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes (AR)

Jaeb Center for Health Research

Status: Not yet enrolling

Conditions: Diabetic Retinal Disease

Treatments: Diagnostic Test: Reading Speed; Diagnostic Test: Contrast sensitivity; Diagnostic Test: Ultrawide field-color photograph; Diagnostic Test: Ultrawide field-Fluorescein angiogram; Diagnostic Test: Visual Field testing; Diagnostic Test: Electroretinography (ERG) and pupillography in light- and dark-adapted states; Diagnostic Test: Optical coherence tomography; Diagnostic Test: Visual Acuity; Other: Optical coherence tomography- Angiography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07270133

Protocol AR

UG1EY014231 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

450 participants in 6 patient groups

Non-diabetic controls

Description:

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

Treatment:

Other: Optical coherence tomography- Angiography

Diagnostic Test: Optical coherence tomography

Diagnostic Test: Visual Acuity

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

Diagnostic Test: Visual Field testing

Diagnostic Test: Ultrawide field-Fluorescein angiogram

Diagnostic Test: Ultrawide field-color photograph

Diagnostic Test: Contrast sensitivity

Diagnostic Test: Reading Speed

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

Treatment:

Other: Optical coherence tomography- Angiography

Diagnostic Test: Optical coherence tomography

Diagnostic Test: Visual Acuity

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

Diagnostic Test: Visual Field testing

Diagnostic Test: Ultrawide field-Fluorescein angiogram

Diagnostic Test: Ultrawide field-color photograph

Diagnostic Test: Contrast sensitivity

Diagnostic Test: Reading Speed

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

Treatment:

Other: Optical coherence tomography- Angiography

Diagnostic Test: Optical coherence tomography

Diagnostic Test: Visual Acuity

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

Diagnostic Test: Visual Field testing

Diagnostic Test: Ultrawide field-Fluorescein angiogram

Diagnostic Test: Ultrawide field-color photograph

Diagnostic Test: Contrast sensitivity

Diagnostic Test: Reading Speed

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

Treatment:

Other: Optical coherence tomography- Angiography

Diagnostic Test: Optical coherence tomography

Diagnostic Test: Visual Acuity

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

Diagnostic Test: Visual Field testing

Diagnostic Test: Ultrawide field-Fluorescein angiogram

Diagnostic Test: Ultrawide field-color photograph

Diagnostic Test: Contrast sensitivity

Diagnostic Test: Reading Speed

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

Treatment:

Other: Optical coherence tomography- Angiography

Diagnostic Test: Optical coherence tomography

Diagnostic Test: Visual Acuity

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

Diagnostic Test: Visual Field testing

Diagnostic Test: Ultrawide field-Fluorescein angiogram

Diagnostic Test: Ultrawide field-color photograph

Diagnostic Test: Contrast sensitivity

Diagnostic Test: Reading Speed

Proliferative diabetic retinopathy

Description:

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

Treatment:

Other: Optical coherence tomography- Angiography

Diagnostic Test: Optical coherence tomography

Diagnostic Test: Visual Acuity

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

Diagnostic Test: Visual Field testing

Diagnostic Test: Ultrawide field-Fluorescein angiogram

Diagnostic Test: Ultrawide field-color photograph

Diagnostic Test: Contrast sensitivity

Diagnostic Test: Reading Speed