Diabetic RetinopathyNCT04905459
ARDA Software for the Detection of mtmDR
An observational study of Diabetic Retinopathy, run by Verily Life Sciences LLC at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- ARDA software application
- How many people
- 1,012 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 Sep 2021to 23 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sites in the U.S.
Who may be able to join
- 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)
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
Who cannot join
- Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
- Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
- Currently participating in an interventional study.
- 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.).
Show all 11Show fewer
- Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.
- Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
- Participant has undergone photodynamic therapy (PDT)
- Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
- Known pregnancy or possibility of pregnancy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
MedStar Health Research Institute Baltimore
Baltimore, Maryland, 21239
Diabetes & Endocrinology Associates of Stark County, Inc
Canton, Ohio, 44718
Christie Clinic
Champaign, Illinois, 61822
Northwestern University
Chicago, Illinois, 60611
The Heart and Medical Center, P.C
Durant, Oklahoma, 74701
Midwestern University
Glendale, Arizona, 85308
Clinical Trials Network
Houston, Texas, 77074
NEA Baptist Clinic
Jonesboro, Arkansas, 72404
Western Michigan University
Kalamazoo, Michigan, 49008
BMG The Endocrine Clinic
Memphis, Tennessee, 38119
Catalina Research Institute
Montclair, California, 91763
Riverside Diabetes Clinic
Riverdale, Maryland, 20737
PMG Research of Winston Salem
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Diabetic Retinopathy
- Being tested
- ARDA software application
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARDA software applicationDiagnostic test
Subject images will be sent to the investigational ARDA software
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ARDA software application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images
Measured: 1 day
Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images
Measured: 1 day
Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images
Measured: 1 day
Specificity of ARDA mtmDR for detection of mtmDR in UWF images
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start30 Sep 2021
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Google LLC., Optos, PLC, Nikon Corporation, The Emmes Company, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905459
- Sponsor's protocol ID
- 101703
- Status last verified
- Jun 2022
- First submitted
- 24 May 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04905459
- Acronym / sponsor ID
- 101703
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Collaborators
- Google LLC., Optos, PLC, Nikon Corporation, The Emmes Company, LLC
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal Imaging and Mydriatic Agents | – | Diagnostic Test: ARDA software applicationSubjects will undergo several types of retinal imaging before and after administration of mydriatic agent. Subjects will be administered mydriatic medication to dilate their pupils. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sites in the U.S.
Key inclusion criteria (4 listed)
- 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)
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
Key exclusion criteria (11 listed)
- Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
- Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
- Currently participating in an interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARDA software applicationSubject images will be sent to the investigational ARDA software | Diagnostic test | Retinal Imaging and Mydriatic Agents |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Verily Life Sciences LLC at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.