Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04296838

Collaborator

Beijing Bethune public welfare fund (Other)

Enrollment

Location

Arm

11.7

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis Macular Edema Vascular Endothelial Growth Factor Effect of Drugs	Drug: intravitreal injection of Conbercept	Phase 2/Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 12, 2019

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: refractory UME patients treated with Conbercept patients in this arm should meet the inclusion criteria and the definition of refractory UME	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

Arm

Intervention/Treatment

Experimental: refractory UME patients treated with Conbercept

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

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

Outcome Measures

Primary Outcome Measures

Changes of best corrected visual acuity (BCVA) [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) [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)

Secondary Outcome Measures

changes of concentration of inflammatory cytokines [before injection (baseline), 1 month after the first injection, at the end of the study (6 months)]
inflammatory cytokines include VEGF-A, VEGF-B, interleukin (IL)-2, interleukin-6, interleukin-8, interleukin-10, interleukin-12, tumor necrosis factor (TNF) α, monocyte chemotactic protein-1 and macrophage inflammatory protein-1
inflammatory status [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
changes from baseline flare and cells in the anterior chamber at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: increase of intraocular pressure [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
changes from baseline intraocular pressure 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]
whether cataract is developed or exacerbated