跳至主要内容
临床试验/NCT06583109
NCT06583109尚未招募不适用

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

Beijing Hospital0 个研究点目标入组 2,600 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,600
主要终点
BCVA

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

BCVA

时间窗: Baseline, 3 months after anti-VEGF treatment, 1 year after anti-VEGF treatment

best-corrected visual acuity using LogMAR

次要结局

  • CMT(Baseline, 3 months after anti-VEGF treatment, 1 year after anti-VEGF treatment)

研究者

发起方
Beijing Hospital
申办方类型
Other Gov
责任方
Sponsor

相似试验