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临床试验/NCT05222633
NCT05222633Unknown不适用

Observation of Anti-vascular Endothelial Growth Factor Therapy in Exudative Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, Macular Edema, and Choroidal Neovascularization.

Wenbin Wei1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Visual acuity

研究概览

简要总结

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

详细描述

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

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
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
  • Undergo intravitreal anti-VEGF therapy

排除标准

  • unable to receive OCT examination
  • Severe corneal opacity, cataract that affect OCT examination

研究组 & 干预措施

Diabetic macula edema

Patients with new-onset and recurrent diabetic macula edema

干预措施: Ranibizumab (Drug)

Neovascular age-related macular edema

Patients with new-onset and recurrent Neovascular age-related macular edema.

干预措施: Ranibizumab (Drug)

Neovascular age-related macular edema

Patients with new-onset and recurrent Neovascular age-related macular edema.

干预措施: Aflibercept (Drug)

Neovascular age-related macular edema

Patients with new-onset and recurrent Neovascular age-related macular edema.

干预措施: Conbercept (Drug)

Diabetic macula edema

Patients with new-onset and recurrent diabetic macula edema

干预措施: Aflibercept (Drug)

Diabetic macula edema

Patients with new-onset and recurrent diabetic macula edema

干预措施: Conbercept (Drug)

Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

干预措施: Ranibizumab (Drug)

Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

干预措施: Aflibercept (Drug)

Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy

干预措施: Conbercept (Drug)

Retinal vein occlusions

Patients with new-onset and recurrent retinal vein occlusions

干预措施: Ranibizumab (Drug)

Choroidal neovascularization

Patients with new-onset and recurrent choroidal neovascularization

干预措施: Ranibizumab (Drug)

Choroidal neovascularization

Patients with new-onset and recurrent choroidal neovascularization

干预措施: Aflibercept (Drug)

Choroidal neovascularization

Patients with new-onset and recurrent choroidal neovascularization

干预措施: Conbercept (Drug)

结局指标

主要结局

Visual acuity

时间窗: 1 year

LogMAR visual acuity

Central subfield thickness

时间窗: 1 year

he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea

次要结局

未报告次要终点

研究者

发起方
Wenbin Wei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wenbin Wei

Director

Beijing Tongren Hospital

研究点 (1)

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