A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus

An observational study of Diabetic Retinopathy, run by Acer Being Health Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetic Retinopathy
How many people: 703 participants
Where: 1 siteTaiwan
Study dates: 16 Dec 2019to 11 May 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Persons with diabetes, twenty years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.

Who may be able to join

Subjects enrolled in this study should meet all the following criteria.
Subject with age ≥ 20 years old
Subject with documented diagnosis of diabetes mellitus
Subject with image taken by color fundus photography that meet the following requirement:
The resolution of image is 1024×1024 pixels or higher;
The angle view of image is 45 or 50 degree.
Subject's image includes macula and optic nerve as judged by the ophthalmologist.

Who cannot join

Subjects will be excluded if they meet any of the following criteria.
The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei, 100

Other trials in Taiwan

About this study

Conditions: Diabetic Retinopathy
Medical subject headings: Diabetic Retinopathy

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity
To evaluate the clinical performance of VeriSee DR by determining the sensitivity.
Sensitivity = 100% x TP/(TP+FN)
Measured: 2 months
Specificity
To evaluate the clinical performance of VeriSee DR by determining the specificity.
Specificity = 100% x TN/(TN+FP)
Measured: 2 months

Secondary outcomes (3)

Positive Predictive Values (PPV)
To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV).
Positive predictive value (PPV) =100% x TP/(TP+FP)
Measured: 2 months
Negative Predictive Values (NPV)
To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV).
Negative predictive value (NPV) = 100% x TN/(FN+TN)
Measured: 2 months
Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR
To determine the percentage of subjects' images with insufficient quality as judged by VeriSee DR.
The percentage of subjects who have the images with insufficient quality as determined by VeriSee DR will be presented.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201911 May 2020

First posted13 Nov 2019
Study start16 Dec 2019
Primary completion31 Jan 2020
Study completion11 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Retrospective
Enrolment: 703 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04160988
Sponsor's protocol ID: QCR19002
Status last verified: Jan 2021
First submitted: 7 Nov 2019
Last updated: 29 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Diabetes Complications, Diabetic Retinopathy
RecruitingPhase 4
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
Diabetic Retinal Disease
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes
Diabetic Retinal Disease

All Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus
ClinicalTrials.gov ID: NCT04160988
Acronym / sponsor ID: QCR19002
Conditions: Diabetic Retinopathy
Study type: Observational
Recruitment status: Completed
Enrolment: 703 participants (actual)
Lead sponsor: Acer Being Health Inc.Industry (pharma, biotech, devices)
Collaborators: National Taiwan University Hospital
Study start: 16 Dec 2019 (actual)
Primary completion: 31 Jan 2020 (actual)
Study completion: 11 May 2020 (actual)
First posted: 13 Nov 2019 (actual)
Results: Posted 29 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Persons with diabetes, twenty years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.

Key inclusion criteria (7 listed)

Subjects enrolled in this study should meet all the following criteria.

Key exclusion criteria (3 listed)

Subjects will be excluded if they meet any of the following criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Sensitivity
Time frame: 2 months
To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)
Specificity
Time frame: 2 months
To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)

3 secondary outcomes

Positive Predictive Values (PPV)
Time frame: 2 months
Negative Predictive Values (NPV)
Time frame: 2 months
Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR
Time frame: 2 months

Results and safety

Results posted to the registry on 29 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Group	703	675

Primary outcome: Sensitivity

Time frame: 2 months. Number (95% Confidence Interval). Unit: percent

Measure	Intended Use Population n = 675
Value	95 (92.48 to 96.82)

Population analysed: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.

Primary outcome: Specificity

Time frame: 2 months. Number (95% Confidence Interval). Unit: percent

Measure	Test Group n = 675
Value	89.9 (85.37 to 96.43)

Population analysed: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: this study is a retrospective study so there is no need to collect adverse event data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Retinopathy

RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Diabetes Complications, Diabetic Retinopathy
RecruitingPhase 4
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
Diabetic Retinal Disease
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes
Diabetic Retinal Disease

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.

1 site 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 Acer Being Health Inc. at 1 site in Taiwan.

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 7 inclusion and 3 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04160988.

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 29 Jan 2021.