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

NCT04774822 | Completed FDA Device

• 1 other identifier: RETINA-AI-CT1
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 3

Brief Summary

Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority 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. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose diabetic retinopathy, this prompted the development of RETINA-AI Galaxy an automated software as a medical device which screens for diabetic retinopathy in the primary care setting. This observational study is designed to validate the safety and efficacy of the device.

Conditions

Diabetic Retinopathy; Diabetic Eye Problems; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• To determine the sensitivity and specificity of RETINA-AI Galaxy to detect more than mild diabetic retinopathy in the primary care setting

  To determine the sensitivity and specificity of RETINA-AI Galaxy for detecting more than mild diabetic retinopathy (mtmDR) defined as moderate non-proliferative diabetic retinopathy, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema.

  1 visit (1 day)

• To determine the sensitivity and specificity of RETINA-AI Galaxy to detect vision-threatening diabetic retinopathy in the primary care setting

  To determine the sensitivity and specificity of RETINA-AI Galaxy for detecting vision threatening diabetic retinopathy (vtDR) defined as severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema.

  1 visit (1 day)

Study Arms (2)

Sequential Enrollment

Enrollment based on default inclusion criteria listed below

Procedure: Color Fundus Photography; Drug: Mydriatics Agent; Procedure: Optical Coherence Tomography (OCT)

Enrichment Enrollment

Enrollment based periodic statistician-activated inclusion criteria adjustment to attain statistically adequate distribution

Procedure: Color Fundus Photography; Drug: Mydriatics Agent; Procedure: Optical Coherence Tomography (OCT)

Interventions

Color Fundus Photography PROCEDURE

Stereoscopic Fundus photography

Enrichment Enrollment; Sequential Enrollment

Mydriatics Agent DRUG

Eye dilating agent

Enrichment Enrollment; Sequential Enrollment

Optical Coherence Tomography (OCT) PROCEDURE

Optical Tomographic imaging of retina

Enrichment Enrollment; 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 documented diagnosis of diabetes as defined by:
• 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 hr 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. Per World Health Organization (WHO) or American Diabetes Association diabetes criteria
• 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 macula edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
• History of retinal laser treatment or intraocular injections of other eye; or any prior history of retinal surgery.
• Current enrolled in another interventional study of an investigational device or drug and actively receiving investigational product for DR or DME
• Subject has a condition that in the principal investigator's opinion would preclude participation in the study (e.g it may confound study results or result in ungradable photographs for clinical reference standard)
• Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate
• Subject is contraindicated from fungus photography (e.g. subject is hypersensitivity to light).

Sponsors & Collaborators

• RETINA-AI Health, Inc.: lead

Study Sites (3)

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Biopharma Informatic LLC

Houston, Texas, 77084, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: March 25, 2021
• Primary Completion: May 28, 2021
• Study Completion: August 31, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (3)