Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Uveitis; Effect of Drugs; Macular Edema; Vascular Endothelial Growth Factor

Treatments: Drug: intravitreal injection of Conbercept

Study type: Interventional

Funder types: Other

Identifiers

NCT04296838

BJ-LM2018010J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

refractory UME patients treated with Conbercept

Experimental group

Description:

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

Treatment:

Drug: intravitreal injection of Conbercept