跳至主要内容
临床试验/NCT03973125
NCT03973125Unknown早期 1 期

Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma: Short-term Follow-up of Anatomical and Functional Responses

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年8月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
50
试验地点
1
主要终点
Best-corrected visual acuity

研究概览

简要总结

The aim of this study was to investigate the safety and effectiveness of application of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma.

详细描述

This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.

排除标准

  • patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.

研究组 & 干预措施

Treatment group

Experimental

The patients in the treatment group receive three monthly intravitreal injection of conbercept followed by PRN rescue treatments such as intravitreal injection of conbercept, laser photocoagulation (when outside the macular) or photodynamic therapy (when in the macular).

干预措施: conbercept (Drug)

结局指标

主要结局

Best-corrected visual acuity

时间窗: half a year

change of best corrected visual acuity

次要结局

  • Central foveal thickness(half a year)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Chen-jin

Professor

Sun Yat-sen University

研究点 (1)

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