ARDA Software for the Detection of mtmDR

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT04905459
• Lead Sponsor: Verily Life Sciences LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2021-09-30
• Primary Completion: 2022-05-23
• Study Completion: 2022-05-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1012

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images	1 day
Specificity of ARDA mtmDR for detection of mtmDR in UWF 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

Trial Locations

Locations (13)

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

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