Age-Related Macular Degeneration (AMD)NCT07069647
Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics
A study testing VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration and Standard fundus photography with physician interpretation in people with Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR)
- What is being tested?
- VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration and Standard fundus photography with physician interpretation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,300 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- VeriSee AMD is used in non-retinal subspecialty ophthalmology clinics for adults aged 50 and above.
- VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above.
Who cannot join
- The patient does not agree to participate in the trial or is unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Yi-Ting Hsieh, Medical Doctor, +886-2-2312-3456 ext. 265018, ythyth@gmail.com
About this study
Official title: Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics: A Randomized Controlled Clinical Trial
Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. This multi-center RCT at National Taiwan University Hospital evaluates the clinical effectiveness and cost-effectiveness of the VeriSee AI-assisted diagnostic software for DR and AMD screening. Participants include adults with diabetes and individuals aged 50 and above meeting AMD screening criteria, randomized to AI-assisted screening with immediate physician explanation or standard physician-only screening. Primary outcomes include detection rates of DR and AMD, ophthalmology referral outcomes, and patient/physician satisfaction. Data collection will occur from April 2025 to December 2027. This study aims to provide evidence on the clinical utility of AI-assisted ophthalmic screening in improving early detection, facilitating timely treatment, and reducing severe visual impairment and healthcare burdens in real-world clinical settings.
Read the detailed description
Background Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are major cause of vision impairment. With an aging population and the increasing prevalence of diabetes, the incidence of both DR and AMD continue to rise. However, due to limited disease literacy and lack of dedicated fundus screening tools in department of internal medicine, many patients are diagnosed and treated at a late stage of the disease. This study aims to evaluate the clinical value of VeriSee artificial intelligence (AI) - assisted diagnostic software among patients with diabetes and the elderly population, focusing on their screening effectiveness and feasibility.
Objective This study aims to evaluate the effectiveness of the VeriSee - an AI-assisted diagnostic software for DR and AMD - in improving the screening rates of macular degeneration, diabetic retinopathy and glaucoma, as well as reducing the incidence of severe visual impairment and lowering overall healthcare burdens. Simultaneously, the investigators will conduct and cost-effectiveness assessment of the VeriSee AI-assisted diagnostic software.
Methods This study is a multicenter, two-arm, parallel-group, open-label, individual-level randomized controlled trial (RCT) conducted at the main branch and Bei-Hu branch of National Taiwan University Hospital. Study participants include: (1) individuals aged 50 and above who meet the screening criteria for AMD; and (2) individuals aged 20 and above with diabetes who meet the screening criteria for DR. Participants are randomized into two groups: (1) the intervention group (AI-assisted screening) in which participants will receive the AI-assisted image analysis followed by immediate explanation of results by a physicians, with ophthalmology referral as needed; and (2) the control group (physician only screening), in which participants undergo standard fundus photography interpreted by physicians, with results discussed during a subsequent visit. During the trial, the ophthalmology referral rates and subsequent diagnostic outcomes will be tracked to evaluate the effectiveness of the AI-assisted diagnostic approach.
Results The study was funded in September 2024. Data collection is expected to last from April 2025 to December 2027. The primary outcome of this study is the detection rate of DR and AMD using the AI-assisted diagnostic software and its impact on diagnosis and treatment following the referral. Referral outcomes will be tracked through electronic medical records (EMR), and both patient and physician satisfaction survey will be conducted to evaluate the feasibility and acceptability of AI implementation in clinical settings.
Conclusions This study is expected to provide evidence on the clinical effectiveness and application value of AI-assisted ophthalmic screening, while also exploring its impact on healthcare procedures and patient care. By enhancing the detection rate of retinal diseases among individuals with diabetes and the elderly, AI-assisted technologies may facilitate earlier diagnosis and timely treatment, potentially improving the visual health and overall quality of life.
- Being tested
- VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration, Standard fundus photography with physician interpretation
- Keywords
- Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), Artificial Intelligence, Randomized Controlled Trial, Fundus Photography
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degenerationOther
VeriSee DR is an AI-assisted diagnosis screening tool for diabetic retinopathy, the software received medical device license approval from the TFDA in 2020 (MOHW-MD-No.006966). VeriSee AMD is an AI-assisted diagnosis screening tool for age-related macular degeneration, the software also received medical device license approval from the TFDA in 2022 (MOHW-MD-No.007652).
Standard fundus photography with physician interpretationOther
The control group will undergo the fundus photography without AI-functionality, with reports interpreted solely by physicians. Participants must schedule a follow-up visit to receive their results.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Screening | Experimental | Intervention group (physicians assisted by AI): After the fundus photography is completed, the AI software (VeriSee AMD and VeriSee DR) will automatically retrieve and analyze the image data from Picture Archiving and Communication System (PACS) to generate the results. The research team will immediately provide the AI-generate results to physicians, enabling participants to receive their reports and results during the same visit. If any abnormalities are detected, the physicians will refer the participants for further ophthalmologic evaluation. Receives: Other: VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration |
| Standard Physician Screening | Active comparator | Control group (physicians diagnosing without AI assistance): After the fundus photography is completed, participants will need to schedule a follow-up appointment with the attending physicians to receive their report and have preliminary assessment of the possibility of DR or AMD. If the physician detects any abnormalities, the physicians will refer the participants for further ophthalmologic evaluation. Receives: Other: Standard fundus photography with physician interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of confirmed cases requiring injection or laser treatment
Number of participants who require injection or laser treatment after diagnosis divided by the total number of confirmed participants.
Measured: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Secondary outcomes (1)
The proportion of screened positive cases requiring treatment, where treatment improves prognosis
Number of screen-positive participants who require treatment and are likely to benefit from the treatment divided by the total number of screen-positive participants.
Measured: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start2 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan, Fu Jen Catholic University Hospital, Min-Sheng General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069647
- Sponsor's protocol ID
- 202505015DINE
- Other IDs
- FJUH114483, CIRB2025003
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuo BI, Wang TA, Chu TC, Chan DC, Cheng SY, Tsai CT, Tsai CL, Lee YC, Chen CJ, Chen WL, Lee JT, Tsai CY, Liu PY, Chang CY, Chao CT, Kao JH, Hsieh YT; Collaborators of AI Ophthalmology Research Group. Artificial Intelligence-Assisted Screening for Patients With Diabetic Retinopathy and Age-Related Macular Degeneration in Family Medicine and Geriatric and Gerontology Care: Protocol for a Pragmatic Randomized Clinical Trial. JMIR Res Protoc. 2026 Jul 6;15:e91699. doi: 10.2196/91699.
PubMed 42406913
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07069647
- Acronym / sponsor ID
- 202505015DINE
- Keywords
- Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), Artificial Intelligence, Randomized Controlled Trial, Fundus Photography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan, Fu Jen Catholic University Hospital, Min-Sheng General Hospital
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jul 2025 (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.
Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. This multi-center RCT at National Taiwan University Hospital evaluates the clinical effectiveness and cost-effectiveness of the VeriSee AI-assisted diagnostic software for DR and AMD screening. Participants include adults with diabetes and individuals aged 50 and above meeting AMD screening criteria, randomized to AI-assisted screening with immediate physician explanation or standard physician-only screening. Primary outcomes include detection rates of DR and AMD, ophthalmology referral outcomes, and patient/physician satisfaction. Data collection will occur from April 2025 to December 2027. This study aims to provide evidence on the clinical utility of AI-assisted ophthalmic screening in improving early detection, facilitating timely treatment, and reducing severe visual impairment and healthcare burdens in real-world clinical settings.
Detailed description
Background Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are major cause of vision impairment. With an aging population and the increasing prevalence of diabetes, the incidence of both DR and AMD continue to rise. However, due to limited disease literacy and lack of dedicated fundus screening tools in department of internal medicine, many patients are diagnosed and treated at a late stage of the disease. This study aims to evaluate the clinical value of VeriSee artificial intelligence (AI) - assisted diagnostic software among patients with diabetes and the elderly population, focusing on their screening effectiveness and feasibility.
Objective This study aims to evaluate the effectiveness of the VeriSee - an AI-assisted diagnostic software for DR and AMD - in improving the screening rates of macular degeneration, diabetic retinopathy and glaucoma, as well as reducing the incidence of severe visual impairment and lowering overall healthcare burdens. Simultaneously, the investigators will conduct and cost-effectiveness assessment of the VeriSee AI-assisted diagnostic software.
Methods This study is a multicenter, two-arm, parallel-group, open-label, individual-level randomized controlled trial (RCT) conducted at the main branch and Bei-Hu branch of National Taiwan University Hospital. Study participants include: (1) individuals aged 50 and above who meet the screening criteria for AMD; and (2) individuals aged 20 and above with diabetes who meet the screening criteria for DR. Participants are randomized into two groups: (1) the intervention group (AI-assisted screening) in which participants will receive the AI-assisted image analysis followed by immediate explanation of results by a physicians, with ophthalmology referral as needed; and (2) the control group (physician only screening), in which participants undergo standard fundus photography interpreted by physicians, with results discussed during a subsequent visit. During the trial, the ophthalmology referral rates and subsequent diagnostic outcomes will be tracked to evaluate the effectiveness of the AI-assisted diagnostic approach.
Results The study was funded in September 2024. Data collection is expected to last from April 2025 to December 2027. The primary outcome of this study is the detection rate of DR and AMD using the AI-assisted diagnostic software and its impact on diagnosis and treatment following the referral. Referral outcomes will be tracked through electronic medical records (EMR), and both patient and physician satisfaction survey will be conducted to evaluate the feasibility and acceptability of AI implementation in clinical settings.
Conclusions This study is expected to provide evidence on the clinical effectiveness and application value of AI-assisted ophthalmic screening, while also exploring its impact on healthcare procedures and patient care. By enhancing the detection rate of retinal diseases among individuals with diabetes and the elderly, AI-assisted technologies may facilitate earlier diagnosis and timely treatment, potentially improving the visual health and overall quality of life.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Screening | Experimental | Other: VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degenerationIntervention group (physicians assisted by AI): After the fundus photography is completed, the AI software (VeriSee AMD and VeriSee DR) will automatically retrieve and analyze the image data from Picture Archiving and Communication System (PACS) to generate the results. The research team will immediately provide the AI-generate results to physicians, enabling participants to receive their reports and results during the same visit. If any abnormalities are detected, the physicians will refer the participants for further ophthalmologic evaluation. |
| Standard Physician Screening | Active comparator | Other: Standard fundus photography with physician interpretationControl group (physicians diagnosing without AI assistance): After the fundus photography is completed, participants will need to schedule a follow-up appointment with the attending physicians to receive their report and have preliminary assessment of the possibility of DR or AMD. If the physician detects any abnormalities, the physicians will refer the participants for further ophthalmologic evaluation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- VeriSee AMD is used in non-retinal subspecialty ophthalmology clinics for adults aged 50 and above.
- VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above.
Key exclusion criteria (1 listed)
- The patient does not agree to participate in the trial or is unable to provide informed consent.
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 |
|---|---|---|
| VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degenerationVeriSee DR is an AI-assisted diagnosis screening tool for diabetic retinopathy, the software received medical device license approval from the TFDA in 2020 (MOHW-MD-No.006966). VeriSee AMD is an AI-assisted diagnosis screening tool for age-related macular degeneration, the software also received medical device license approval from the TFDA in 2022 (MOHW-MD-No.007652). | Other | AI-Assisted Screening |
| Standard fundus photography with physician interpretationThe control group will undergo the fundus photography without AI-functionality, with reports interpreted solely by physicians. Participants must schedule a follow-up visit to receive their results. | Other | Standard Physician Screening |
Primary outcome
The proportion of confirmed cases requiring injection or laser treatment
Time frame: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Number of participants who require injection or laser treatment after diagnosis divided by the total number of confirmed participants.
1 secondary outcome
The proportion of screened positive cases requiring treatment, where treatment improves prognosis
Time frame: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 42406913Kuo BI, Wang TA, Chu TC, Chan DC, Cheng SY, Tsai CT, Tsai CL, Lee YC, Chen CJ, Chen WL, Lee JT, Tsai CY, Liu PY, Chang CY, Chao CT, Kao JH, Hsieh YT; Collaborators of AI Ophthalmology Research Group. Artificial Intelligence-Assisted Screening for Patients With Diabetic Retinopathy and Age-Related Macular Degeneration in Family Medicine and Geriatric and Gerontology Care: Protocol for a Pragmatic Randomized Clinical Trial. JMIR Res Protoc. 2026 Jul 6;15:e91699. doi: 10.2196/91699.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration and Standard fundus photography with physician interpretation in people with Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), run by National Taiwan University Hospital 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of confirmed cases requiring injection or laser treatment (time frame: From screening to physician-confirmed diagnosis of AMD or DR, an average of 1 month). 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 NCT07069647, which also lists 1 linked publication.
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 22 Jul 2026.