Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-12

Study Completion Date

2022-02-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Uveitis Macular Edema Vascular Endothelial Growth Factor Effect of Drugs

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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refractory UME patients treated with Conbercept

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

Group Type EXPERIMENTAL

intravitreal injection of Conbercept

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lumitin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No