Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device

NCT05368623 | Completed FDA Device

• 1 other identifier: RETINA-AI-CT2
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 3

Brief Summary

Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). However, majority of diabetic patients do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection via effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy™ v2.0, an automated Software as a Medical Device that screens for diabetic retinopathy in the primary care setting. This observational study was designed to validate the safety and efficacy of the RETINA-AI Galaxy™ Software-as-a-Medical-Device.

Conditions

Diabetes; Diabetic Retinopathy; Diabetic Macular Edema; Diabetic Eye Problems

Outcome Measures

Primary Outcomes (1)

• To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 for diabetic retinopathy screening in the primary care setting.

  1 visit (1 day)

Study Arms (1)

Sequential Enrollment

Patients aged 22yrs or older who have diabetes will be recruited from primary care settings.

Diagnostic Test: Color fundus photograph; Diagnostic Test: Optical Coherence Tomography (OCT) of the retina; Drug: Mydriatic Agent

Interventions

Color fundus photograph DIAGNOSTIC_TEST

Subjects will undergo color fundus photography before and after pharmacological dilation of pupils.

Sequential Enrollment

Optical Coherence Tomography (OCT) of the retina DIAGNOSTIC_TEST

Subjects will undergo OCT of the retina after pharmacological dilation of pupils.

Sequential Enrollment

Mydriatic Agent DRUG

Pharmacological dilation of pupils will be done by instilling mydriatic agent in eyes of Subjects

Sequential Enrollment

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

Study subjects from Primary Care clinics - sampling method: non-probability, invitation to volunteer

You may qualify if:

• Patient age 22 or above
• Patient with a documented diagnosis of diabetes as defined by any of the following:
• A. Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments B. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments C. Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
• D. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L) E. Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).
• Understanding of the Study and willingness and ability to sign informed consent

You may not qualify if:

• Persistent vision loss in one or both eyes
• Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion.
• History of retinal laser treatment, or injections into either eye, or any history of retinal surgery.
• Currently enrolled in another interventional study of an investigational device or drug and actively receiving an investigational product for diabetic retinopathy (DR) or Diabetic Macula Edema (DME).
• Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate.
• Subject is contraindicated from fundus photography (e.g. subject is hypersensitive to light).

Sponsors & Collaborators

• RETINA-AI Health, Inc.: lead

Study Sites (3)

Clinical Research Organization

Los Angeles, California, 92844, United States

Location

Clinical Research Organization

Chicago, Illinois, 60402, United States

Location

Clinical Research Organization

Houston, Texas, 77074, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Interventions

Tomography, Optical Coherence; Mydriatics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

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

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: November 3, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (3)