An Assistant Model for Anti-VEGF Therapy Decision

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Assistant Model for IRD Care Needs: A Randomized Control Trial

NCT06839170

Inherited Retinal Diseases

COMPLETED NA

This Project At LMU Looks At How Using AI 2nd Opinion Report to Analyze Retinal Eye Scans Impact Doctors' Decisions About Treatment for Patients with a Specific Eye Disease (nAMD)

NCT06817915

Neovascular Age-Related Macular Degeneration (nAMD)

NOT_YET_RECRUITING NA

Computer Aided Diagnosis of Multiple Eye Fundus Diseases From Color Fundus Photograph

NCT04723160

Diabetic Retinopathy Retinal Vein Occlusion Retinal Artery Occlusion +10 more

COMPLETED

Ophthalmic Multimodal AI-Assisted Medical Decision-Making

NCT06755190

Ocular Diseases

RECRUITING

Multi-modal Intelligent Diagnosis System for Multiple Ophthalmic Diseases

NCT07143851

Retina Disease Glaucoma

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FM-VEGF-CDSS assisted arm

Group Type EXPERIMENTAL

FM-VEGF-CDSS assisted

Intervention Type OTHER

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

without FM-VEGF-CDSS assisted arm

Group Type ACTIVE_COMPARATOR

without FM-VEGF-CDSS

Intervention Type OTHER

without FM-VEGF-CDSS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FM-VEGF-CDSS assisted

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

Intervention Type OTHER

without FM-VEGF-CDSS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No