ARDA Software for the Detection of mtmDR

• Sponsor: Verily Life Sciences LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04905459
• Collaborator: Google LLC. (Industry), Optos, PLC (Industry), Nikon Corporation (Other), The Emmes Company, LLC (Industry)
• Enrollment: 1,012
• Locations: 13
• Actual Duration (Months): 7.7
• Patients Per Site: 77.8
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Diagnostic Test: ARDA software application

Study Design

• Study Type: Observational
• Actual Enrollment: 1012 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
• Actual Study Start Date: Sep 30, 2021
• Actual Primary Completion Date: May 23, 2022
• Actual Study Completion Date: May 23, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images [1 day]

2. Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images [1 day]

3. Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images [1 day]

4. Specificity of ARDA mtmDR for detection of mtmDR in UWF images [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. Age 22 or older

2. 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.

8. Participant is hypersensitive to light (side effect of medication or due to unknown etiology)

9. Participant has undergone photodynamic therapy (PDT)

10. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).

11. Known pregnancy or possibility of pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Midwestern University	Glendale	Arizona	United States	85308
2	NEA Baptist Clinic	Jonesboro	Arkansas	United States	72404
3	Catalina Research Institute	Montclair	California	United States	91763
4	Christie Clinic	Champaign	Illinois	United States	61822
5	Northwestern University	Chicago	Illinois	United States	60611
6	MedStar Health Research Institute Baltimore	Baltimore	Maryland	United States	21239
7	Riverside Diabetes Clinic	Riverdale	Maryland	United States	20737
8	Western Michigan University	Kalamazoo	Michigan	United States	49008
9	PMG Research of Winston Salem	Winston-Salem	North Carolina	United States	27103
10	Diabetes & Endocrinology Associates of Stark County, Inc	Canton	Ohio	United States	44718
11	The Heart and Medical Center, P.C	Durant	Oklahoma	United States	74701
12	BMG The Endocrine Clinic	Memphis	Tennessee	United States	38119
13	Clinical Trials Network	Houston	Texas	United States	77074

Sponsors and Collaborators

• Verily Life Sciences LLC
• Google LLC.
• Optos, PLC
• Nikon Corporation
• The Emmes Company, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Verily Life Sciences LLC
• ClinicalTrials.gov Identifier: NCT04905459
• Other Study ID Numbers: 101703
• First Posted: May 27, 2021
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy

Study Results

No Results Posted as of Jun 6, 2022