DMENCT07328776
AI vs. Physician for Anti-VEGF Decision-Making: An RCT
A study testing QiLin-assisted and physician only, without QiLin assisted in people with DME and Retinal Vein Occlusion (RVO), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
We developed an artificial intelligence system, called QiLin, which was designed to assist anti-VEGF treatment decisions in retinal diseases. QiLin was trained and validated via over 20,000 optical coherence tomography images from multicenter datasets, demonstrating strong performance on both internal and external… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- DME, Retinal Vein Occlusion (RVO), Neovascular (Wet) Age-Related Macular Degeneration
- What is being tested?
- QiLin-assisted and physician only, without QiLin assisted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 25 May 2026to 15 Oct 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of nAMD, DME, and RVO; Patients who have completed the loading-dose treatment of anti-VEGF agents; Patients who were willing to participate and provided written informed consent.
Who cannot join
- Refusal to undergo OCT testing; Refusal to complete the 3-month follow-up period; Screening for a history of intraocular surgery within the past 6 months; Subjects with severe systemic diseases, intellectual developmental disorders, psychiatric illnesses, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shanghai general hospital, Shanghai Jiao Tong University, Shanghai, 200080
Shanghai
Xiaodong Sun, PhD, +86-02163240090, xdsun@sjtu.edu.cn
Shanghai general hospital
Shanghai
Huixun Jia, PhD, 86 17853138155, jiahuixun@sjtu.edu.cn
About this study
Official title: An Artificial Intelligence System for Anti-VEGF Treatment Decisions in Retinal Diseases: A Randomized Controlled Trial
We developed an artificial intelligence system, called QiLin, which was designed to assist anti-VEGF treatment decisions in retinal diseases. QiLin was trained and validated via over 20,000 optical coherence tomography images from multicenter datasets, demonstrating strong performance on both internal and external validation. To evaluate its real-world clinical utility, we conducted a randomized controlled trial that rigorously compares the accuracy of treatment decisions between a physician-only arm and an AI-assisted physician arm.
- Being tested
- QiLin-assisted, physician only, without QiLin assisted
- Medical subject headings
- Retinal Vein Occlusion, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QiLin-assistedOther
A Comprehensive Deep Learning Model for Assisting the decision of anti-VEGF therapy: QiLin system
physician only, without QiLin assistedOther
without QiLin assisted
| Study group | Role | What they receive |
|---|---|---|
| QiLin-assisted physician arm | Experimental | Not described Receives: Other: QiLin-assisted |
| physician only arm | Active comparator | Not described Receives: Other: physician only, without QiLin assisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the current anti-VEGF injection decision
The accuracy of the current anti-VEGF injection decision was defined as the proportion of injection decisions (yes or no) made by the physicians in the two arms that were in agreement with the independent senior expert.
Measured: At enrollment
Secondary outcomes (1)
Accuracy of detecting active biomarkers on the current OCT image
The secondary endpoint was defined as the accuracy of detecting active biomarkers. For each patient, the physician was required to perform a binary classification (present vs. absent) for all of 8 pre-defined active biomarkers (PED, NV, IRF, SRF, SHRM, HRF, DRT or DME, and VMT), and was further confirmed by an independent senior retina specialist. The accuracy for per biomarker was calculated as the proportion of correct classifications for that biomarker, and then the average accuracy was calculated as the secondary endpoint.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start25 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMEStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaodong Sun, PhD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328776
- Sponsor's protocol ID
- SXD20251227
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence System for Anti-VEGF Treatment Decisions in Retinal Diseases: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07328776
- Acronym / sponsor ID
- SXD20251227
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 9 Jan 2026 (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.
We developed an artificial intelligence system, called QiLin, which was designed to assist anti-VEGF treatment decisions in retinal diseases. QiLin was trained and validated via over 20,000 optical coherence tomography images from multicenter datasets, demonstrating strong performance on both internal and external validation. To evaluate its real-world clinical utility, we conducted a randomized controlled trial that rigorously compares the accuracy of treatment decisions between a physician-only arm and an AI-assisted physician arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QiLin-assisted physician arm | Experimental | Other: QiLin-assisted |
| physician only arm | Active comparator | Other: physician only, without QiLin assisted |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of nAMD, DME, and RVO; Patients who have completed the loading-dose treatment of anti-VEGF agents; Patients who were willing to participate and provided written informed consent.
Key exclusion criteria (1 listed)
- Refusal to undergo OCT testing; Refusal to complete the 3-month follow-up period; Screening for a history of intraocular surgery within the past 6 months; Subjects with severe systemic diseases, intellectual developmental disorders, psychiatric illnesses, etc.
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 |
|---|---|---|
| QiLin-assistedA Comprehensive Deep Learning Model for Assisting the decision of anti-VEGF therapy: QiLin system | Other | QiLin-assisted physician arm |
| physician only, without QiLin assistedwithout QiLin assisted | Other | physician only arm |
Primary outcome
Accuracy of the current anti-VEGF injection decision
Time frame: At enrollment
The accuracy of the current anti-VEGF injection decision was defined as the proportion of injection decisions (yes or no) made by the physicians in the two arms that were in agreement with the independent senior expert.
1 secondary outcome
Accuracy of detecting active biomarkers on the current OCT image
Time frame: At enrollment
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 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaodong Sun, PhD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QiLin-assisted and physician only, without QiLin assisted in people with DME and Retinal Vein Occlusion (RVO), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
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 1 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Contact Xiaodong Prof. Sun, PhD (86 17853138155, xdsun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the current anti-VEGF injection decision (time frame: At enrollment). 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 22 May 2026.