ARDA Software for the Detection of mtmDR

• ClinicalTrials.gov Identifier: NCT04905459
• Recruitment Status: Completed
• First Posted: May 27, 2021
• Last Update Posted: June 6, 2022
• Sponsor: Verily Life Sciences LLC
• Collaborators: Google LLC.; Optos, PLC; Nikon Corporation; The Emmes Company, LLC
• Information provided by (Responsible Party): Verily Life Sciences LLC

Tracking Information

• First Submitted Date: May 24, 2021
• First Posted Date: May 27, 2021
• Last Update Posted Date: June 6, 2022
• Actual Study Start Date: September 30, 2021
• Actual Primary Completion Date: May 23, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2021)

• Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images [ Time Frame: 1 day ]
• Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images [ Time Frame: 1 day ]
• Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images [ Time Frame: 1 day ]
• Specificity of ARDA mtmDR for detection of mtmDR in UWF images [ Time Frame: 1 day ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ARDA Software for the Detection of mtmDR
• Official Title: A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Sites in the U.S.
• Condition: Diabetic Retinopathy

Intervention

Diagnostic Test: ARDA software application

Subject images will be sent to the investigational ARDA software

Study Groups/Cohorts

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.

Intervention: Diagnostic Test: ARDA software application

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 1, 2022): 1012
• Original Estimated Enrollment (submitted: May 24, 2021): 1008
• Actual Study Completion Date: May 23, 2022
• Actual Primary Completion Date: May 23, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04905459
• Other Study ID Numbers: 101703
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Verily Life Sciences LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Verily Life Sciences LLC
• Original Study Sponsor: Same as current

Collaborators

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

• Investigators: Not Provided
• PRS Account: Verily Life Sciences LLC
• Verification Date: June 2022