Prediction Model of Treatment Efficacy for Age-related Macular Degeneration Based on Multi-source Imaging Modalities

Not yet recruiting

• Conditions: Age-related Macular Degeneration (ARMD)

• Registration Number: NCT06583109
• Lead Sponsor: Beijing Hospital

Brief Summary

Age-related macular degeneration (AMD) is one of the main causes of blindness in the elderly population. Intraocular injection of anti-VEGF drugs for neovascular AMD (nAMD) is the main treatment method at present. However, patients have different responses to anti-VEGF therapy, and some patients do not respond well to short - and long-term treatment.

In this study, a retrospective study was adopted to collate and analyze the clinical data and imaging data of nAMD in the past, and to extract the imaging features from the multimodal modalities before and after treatment for deep learning, and to evaluate and quantify the clinical features, and to construct two multi-source feature models for predicting the short-term and long-term prognosis of nAMD patients. By verifying the accuracy of the model to predict the curative effect, the classification efficiency of the above characteristic models was compared, and the optimal model was selected. Its clinical application value was evaluated by calibration curve and decision curve. In addition, patients with poor treatment response in the study cohort were retrospectively analyzed, and the efficacy and safety of the combination of other treatment options in the actual clinic were analyzed. The purpose of this study is to provide scientific basis for early prediction, dynamic monitoring and optimization of overall treatment strategies for nAMD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Study Start: 2024-10-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

• Patients diagnosed with nAMD by ophthalmic examinations including OCT, OCTA, FFA and ICGA;
• Complete clinical data and imaging data of patients were available at baseline, 3 months and 1 year after anti-VEGF treatment.

Exclusion Criteria

• Medical records showed other diseases affecting visual function or fundus imaging, such as macular edema, glaucoma, ocular trauma, etc;
• Medical records showed that two or more macular lesions coexist in the affected eye;
• Medical records showed that patients received other treatments within 1 year of anti-VEGF therapy, such as intraocular laser therapy or ocular surgery;
• Medical records showed that there were ocular media opacity, dense macular hemorrhage, or severe macular atrophy, resulting in the inability to accurately measure the required parameters;
• Medical records showed the use of drugs known to cause retinal toxicity, or a history of radiation exposure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BCVA	Baseline, 3 months after anti-VEGF treatment, 1 year after anti-VEGF treatment	best-corrected visual acuity using LogMAR

Secondary Outcome Measures

Name	Time	Method
CMT	Baseline, 3 months after anti-VEGF treatment, 1 year after anti-VEGF treatment	central macular thickness measured on OCT