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临床试验/NCT05418231
NCT05418231尚未招募不适用

Observation of the Natural Course of Dry Age-related Macular Degeneration

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年7月最近更新:
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
500
试验地点
1
主要终点
Visual acuity

研究概览

简要总结

This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-85 yrs male or female AMD patients
  • Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.

排除标准

  • Any eye with disease that would interfere with the retinal examinations
  • Research eye with CNV or high myopia
  • Surgeries that may interfere with AMD evaluation
  • Long-term uses of medications that are associated with retinal or neural toxicities.
  • IOP more than 26 mmHg
  • Received cataract surgery in 3 months.
  • Other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
  • Other conditions not suitable for the current study

结局指标

主要结局

Visual acuity

时间窗: 60 months

A typical ETDRS chart that if frequently used for visual acuity testing

次要结局

  • The rate of 5-year progression(60 months)
  • Drusen density and shape(60 months)
  • GA growth rate(60 months)

研究者

发起方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaodong Sun

Professor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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