Title

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

    Phase 2/Phase 3
  • Study Type

    Interventional
  • Status

    Terminated
  • Study Participants

    5
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.
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.
Study Started
Oct 12
2019
Primary Completion
Apr 12
2020
Study Completion
Feb 12
2022
Last Update
Oct 25
2022

Drug intravitreal injection of Conbercept

patients will receive intravitreal injection of Conbercept, and at the same time, aqueous humor sample will be obtained from the anterior chamber to measure the concentrations of cytokines.

  • Other names: Lumitin

refractory UME patients treated with Conbercept Experimental

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted