OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection

NCT06343350 | Completed FDA Device

• 1 other identifier: OPTDR01P
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates. A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR.

Conditions

Diabetic Retinopathy; Diabetes

Keywords

Artificial Intelligence; Diabetic Retinopathy; SaMD; Screening

Outcome Measures

Primary Outcomes (1)

• Enrollment rate of eligible participants at clinical site

  Number of eligible participants that are enrolled on a weekly basis at a clinical site

  Assessed weekly until study end

Study Arms (1)

Retinal imaging

Participants will undergo retinal imaging with and without mydriatic agent to dilate the pupils.

Device: OPTDR01 software application

Interventions

OPTDR01 software application DEVICE

Retinal images will be sent to the OPTDR01 software application for mtmDR and vtDR detection

Retinal imaging

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Type I or Type II diabetes that are eligible for Diabetic Retinopathy screening

You may qualify if:

• Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA):
• Age 22 or older
• Understand the study and volunteer to sign the informed consent

You may not qualify if:

• Unable to understand the study
• Unwilling to sign informed consent
• Indicate persistent vision loss, blurred vision, or floaters
• Previous diagnosis of macular edema, diabetic retinopathy (any level) proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
• History of laser treatment of the retina or injections into either eye, or any history of retinal surgery
• Currently participating in another investigational eye study or actively receiving investigational product for diabetic retinopathy or diabetic macular edema
• A condition that, in the opinion of the investigator, would preclude participation in the study
• Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity
• Known pregnancy

Sponsors & Collaborators

• Global BioClinical: collaborator
• Optain Health: lead

Study Sites (3)

Gastro SB

Chula Vista, California, 91910, United States

Location

Triwest Research Associates

San Diego, California, 92108, United States

Location

Gulf Coast Clinical Research

Houston, Texas, 77070, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 2, 2024
• Study Start: April 1, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)