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An Assistant Model for Anti-VEGF Therapy Decision

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Retinal Vein Occlusion (RVO)
DME
Exudative Age-Related Macular Degeneration

Treatments

Other: without FM-VEGF-CDSS
Other: FM-VEGF-CDSS assisted

Study type

Interventional

Funder types

Other

Identifiers

NCT07328776
SXD20251227

Details and patient eligibility

About

We present FM-VEGF-CDSS system, the first foundation model-based AI system specifically designed for the decision of anti-VEGF therapy by emulating clinician decision-making reasoning process for those with exudative retinal diseases. FM-VEGF-CDSS is capable of processing multimodal input including optical coherence tomography (OCT) and descriptive medical metadata. Trained and validated on cases from centers across China, the system performed well in both internal and external validation dataset, and could generate the convenient report to enhance decision-making interpretability. To validate its clinical practice, we conducted a prospective multicenter RCT, rigorously assessing FM-VEGF-CDSS system's prediction accuracy and real-world utility. This will improve the standardized decision for anti-VEGF therapy, promoting health equity.

Enrollment

160 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Presenting with clinical features suggestive of exudative retinal diseases based on the initial assessment by the physician

Exclusion criteria

  • Refusal to undergo OCT testing; Refusal to complete the 6-month follow-up period; Screening for a history of intraocular surgery in both eyes within the past 6 months; Subjects with severe systemic diseases, intellectual developmental disorders, psychiatric illnesses, etc.

Patient data that the investigator deems necessary to exclude.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups

FM-VEGF-CDSS assisted arm
Experimental group
Treatment:
Other: FM-VEGF-CDSS assisted
without FM-VEGF-CDSS assisted arm
Active Comparator group
Treatment:
Other: without FM-VEGF-CDSS

Trial contacts and locations

2

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Central trial contact

Huixun Jia, PhD; Xiaodong Prof. Sun, PhD

Data sourced from clinicaltrials.gov

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