跳至主要内容
临床试验/NCT04296838
NCT04296838终止2 期

Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年10月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
5
试验地点
1
主要终点
Changes of best corrected visual acuity (BCVA)

研究概览

简要总结

As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.

详细描述

Uveitic macular edema (UME) is one of the commonest and severest complications of chronic uveitis, and is also one of the important causes of permanent vision loss in uveitis. The pathophysiological mechanism of UME remains unclear, but was thought to be caused by damages of internal/external blood-retinal barrier mediated by inflammatory factors, including interleukin-2, interleukin-10, tumor necrosis factor α, prostaglandins and vascular endothelial growth factor (VEGF). Current treatments of UME include local or systemic glucocorticosteroids (GCS), immunosuppressants and biological agents. Although large dose of systemic GCS combined with immunosuppressants lead to quick resolution of ME in most of the cases, UME often relapse with tapering of GCS, and the side effects can be significant. Periocular or intraocular injection of GCS is effective in short term, but repetitive injections often lead to high intraocular pressure and cataract. Intravitreal injection of anti-VEGF agents is a huge advance of medical treatment in ophthalmology in recent years. Since 2007 till now, there have been a number of reports on the effectiveness of intraocular Bevacizumab and Ranibizumab injection in UME, but none about Conbercept. Besides, as the target of anti-VEGF agents, intraocular concentration of VEGF and its changes might be correlated to the sensitivity and responsiveness of UME to anti-VEGF agents, but has not been monitored. As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >= 18 years old
  • competent in signing the informed consent
  • no severe systemic diseases unrelated to uveitis
  • fulfill the criteria of refractory UME

排除标准

  • pregnant or preparing pregnancy
  • already in other clinical trials
  • blood pressure >= 180/110mmHg
  • BCVA of the contralateral eye <= 20/200
  • cardiovascular events within 3 months

研究组 & 干预措施

refractory UME patients treated with Conbercept

Experimental

patients in this arm should meet the inclusion criteria and the definition of refractory UME

干预措施: intravitreal injection of Conbercept (Drug)

结局指标

主要结局

Changes of best corrected visual acuity (BCVA)

时间窗: baseline and at 1, 2, 3, 4, 5, 6 months after injection

changes from baseline BCVA at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)

Changes of central retinal thickness (CRT)

时间窗: baseline and at 1, 2, 3, 4, 5, 6 months after injection

changes from baseline CRT at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)

次要结局

  • changes of concentration of inflammatory cytokines(before injection (baseline), 1 month after the first injection, at the end of the study (6 months))
  • side effects of the eye: increase of intraocular pressure(baseline and at 1, 2, 3, 4, 5, 6 months after injection)
  • side effects of the eye: development/exacerbation of cataract(baseline and at 1, 2, 3, 4, 5, 6 months after injection)
  • inflammatory status(baseline and at 1, 2, 3, 4, 5, 6 months after injection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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