ARDA Software for the Detection of mtmDR

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Diagnostic test: ARDA software application

• Study Type: Observational
• Enrollment (Actual): 1012

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Midwestern University
  • Arkansas
    • Jonesboro, Arkansas, United States, 72404
      • NEA Baptist Clinic
  • California
    • Montclair, California, United States, 91763
      • Catalina Research Institute
  • Illinois
    • Champaign, Illinois, United States, 61822
      • Christie Clinic
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • MedStar Health Research Institute Baltimore
    • Riverdale, Maryland, United States, 20737
      • Riverside Diabetes Clinic
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • Western Michigan University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston Salem
  • Ohio
    • Canton, Ohio, United States, 44718
      • Diabetes & Endocrinology Associates of Stark County, Inc
  • Oklahoma
    • Durant, Oklahoma, United States, 74701
      • The Heart and Medical Center, P.C
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • BMG The Endocrine Clinic
  • Texas
    • Houston, Texas, United States, 77074
      • Clinical Trials Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sites in the U.S.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retinal Imaging and Mydriatic Agents; Subjects will undergo several types of retinal imaging before and after administration of mydriatic agent. Subjects will be administered mydriatic medication to dilate their pupils.	Diagnostic test: ARDA software application; Subject images will be sent to the investigational ARDA software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images	1 day
Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images	1 day
Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images	1 day
Specificity of ARDA mtmDR for detection of mtmDR in UWF images	1 day

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC
• Collaborators: The Emmes Company, LLC; Optos, PLC; Google LLC.; Nikon Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): May 23, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 101703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes