ARDA Software for the Detection of mtmDR

Diabetic Retinopathy Clinical Trial

Official title:

A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905459
• Other study ID #: 101703
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

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