An Assistant Model for Anti-VEGF Therapy Decision

NCT07328776 | Not Yet Recruiting

• 1 other identifier: SXD20251227
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The prediction accuracy of anti-VEGF therapy interval

  From enrollment to the end of follow-up at 6 months or to the next anti-VEGF therapy

Study Arms (2)

FM-VEGF-CDSS assisted arm

EXPERIMENTAL

Other: FM-VEGF-CDSS assisted

without FM-VEGF-CDSS assisted arm

ACTIVE COMPARATOR

Other: without FM-VEGF-CDSS

Interventions

FM-VEGF-CDSS assisted OTHER

A Comprehensive Deep Learning Model for Assisting the decision of anti-VEGF therapy: FM-VEGF-CDSS system

FM-VEGF-CDSS assisted arm

without FM-VEGF-CDSS OTHER

without FM-VEGF-CDSS

without FM-VEGF-CDSS assisted arm

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai general hospital, Shanghai Jiao Tong University, Shanghai, 200080

Shanghai, China

Location

Shanghai general hospital

Shanghai, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaodong Sun, PhD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Prof. Sun, PhD

CONTACT

86 18017317575; xdsun@sjtu.edu.cn

Huixun Jia, PhD

CONTACT

86 18017317575; jiahuixun@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

CN (2)