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

Completed

Conditions studied: Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT04774822

Run by

RETINA-AI Health, Inc.

People needed

397

Starts

2021-03-25

Expected to finish

2021-08-31

Last updated by the study team

2021-09-16

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Biopharma Informatic, LLC — Houston, Texas, United States
• Clinical Trial Network — Houston, Texas, United States
• Biopharma Informatic LLC — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.