Clinical Trial

AI vs. Physician for Anti-VEGF Decision-Making: An RCT

Not Yet Recruiting
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Record status
This record was last updated May 22, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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 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.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-05-23
notable Enrollment increased: 160 -> 200 participants 2026-05-23
notable Primary completion moved earlier: 2026-08-31 -> 2026-07-01 2026-05-23
minor Completion pushed: 2026-08-31 -> 2026-10-15 2026-05-23
Trial Details
NCT Number NCT07328776
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions DME, Retinal Vein Occlusion (RVO), Neovascular (Wet) Age-Related Macular Degeneration
Enrollment 200 participants
Start Date 2026-05-25
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-22