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COMPLETED
NCT07707856

AI Prediction of Treatment Response in DME

Sponsor: Benha University

View on ClinicalTrials.gov

Summary

Diabetic macular edema (DME) is a leading cause of vision loss among individuals with diabetes mellitus. Although intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is the standard treatment for center-involved DME, treatment response varies considerably between patients. Recent advances in artificial intelligence (AI), including machine learning (ML) and deep learning (DL), have enabled automated analysis of retinal imaging biomarkers to predict anatomical and functional treatment outcomes. This study aims to systematically evaluate published evidence regarding AI-based prediction models and imaging biomarkers used to predict treatment response in patients with DME. The review will assess the predictive performance of AI models, identify the most important imaging biomarkers, compare different AI approaches and imaging modalities, and summarize methodological strengths, limitations, and research gaps to support future development of precision ophthalmology.

Official title: Artificial Intelligence and Imaging Biomarkers for Predicting Treatment Response in Diabetic Macular Edema: A Systematic Review

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1284

Start Date

2025-05-15

Completion Date

2025-06-30

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

OTHER

Artificial Intelligence-Based Imaging Analysis

Participants undergo retinal imaging analysis using artificial intelligence-based prediction models developed from optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), fundus photography, and relevant clinical variables. The AI algorithms are used to predict treatment response in diabetic macular edema, including anatomical and functional outcomes following anti-vascular endothelial growth factor (anti-VEGF), corticosteroid, laser, or combination therapies. The AI analysis does not alter clinical management and is performed for predictive evaluation only.

Locations (1)

Benha University

Banhā, Benha, Egypt