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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04905459
Other study ID # 101703
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date May 23, 2022

Study information

Verified date June 2022
Source Verily Life Sciences LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1012
Est. completion date May 23, 2022
Est. primary completion date May 23, 2022
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: 1. 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) 2. Age 22 or older 3. Understand the study and volunteer to sign the informed consent Exclusion Criteria: 1. Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses). 2. Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion. 3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery. 4. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy. 5. Currently participating in an interventional study. 6. 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.). 7. Participant is contraindicated for imaging by fundus imaging system used in the study; e.g. 1. Participant is hypersensitive to light (side effect of medication or due to unknown etiology) 2. Participant has undergone photodynamic therapy (PDT) 3. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops). 8. Known pregnancy or possibility of pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ARDA software application
Subject images will be sent to the investigational ARDA software

Locations

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

Sponsors (5)

Lead Sponsor Collaborator
Verily Life Sciences LLC Google LLC., Nikon Corporation, Optos, PLC, The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images 1 day
Primary Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images 1 day
Primary Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images 1 day
Primary Specificity of ARDA mtmDR for detection of mtmDR in UWF images 1 day
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