AI vs. Physician for Anti-VEGF Decision-Making: An RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QiLin-assisted, physician only, without QiLin assisted.
- Who it may be relevant to
- Registry conditions: DME, Retinal Vein Occlusion (RVO), Neovascular (Wet) Age-Related Macular Degeneration. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Artificial Intelligence System for Anti-VEGF Treatment Decisions in Retinal Diseases: A Randomized Controlled Trial
Overview
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.
Interventions
- Other QiLin-assisted
A Comprehensive Deep Learning Model for Assisting the decision of anti-VEGF therapy: QiLin system - Other physician only, without QiLin assisted
without QiLin assisted
Primary outcome measures
- Accuracy of the current anti-VEGF injection decision [Time frame: At enrollment]
Secondary outcome measures (1)
- Accuracy of detecting active biomarkers on the current OCT image [Time frame: At enrollment]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
China · 2 centers
- Shanghai general hospital, Shanghai Jiao Tong University, Shanghai, 200080 — Shanghai
- Shanghai general hospital — Shanghai
Identifiers
NCT: NCT07328776 · SXD20251227