ARDA Software for the Detection of mtmDR

Completed

Conditions studied: Diabetic Retinopathy

In brief

This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.

Key facts

Study ID

NCT04905459

Run by

Verily Life Sciences LLC

People needed

1012

Starts

2021-09-30

Expected to finish

2022-05-23

Last updated by the study team

2022-06-06

Who can join

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

You may qualify if…

• Documented diagnosis of Type I or Type II diabetes mellitus:
• meet 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…

• Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
• Diagnosed with macular edema, any known 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.
• Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
• Currently participating in an interventional study.
• Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).
• Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.
• Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
• Participant has undergone photodynamic therapy (PDT)
• Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
• Known pregnancy or possibility of pregnancy

Where it is running

• Midwestern University — Glendale, Arizona, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Catalina Research Institute — Montclair, California, United States
• Christie Clinic — Champaign, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• MedStar Health Research Institute Baltimore — Baltimore, Maryland, United States
• Riverside Diabetes Clinic — Riverdale, Maryland, United States
• Western Michigan University — Kalamazoo, Michigan, United States
• PMG Research of Winston Salem — Winston-Salem, North Carolina, United States
• Diabetes & Endocrinology Associates of Stark County, Inc — Canton, Ohio, United States
• The Heart and Medical Center, P.C — Durant, Oklahoma, United States
• BMG The Endocrine Clinic — Memphis, Tennessee, United States
• Clinical Trials Network — Houston, Texas, United States

Full record on ClinicalTrials.gov

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