Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04296838
• Other study ID #: BJ-LM2018010J
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: October 12, 2019
• Est. completion date: February 12, 2022

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 12, 2022
• Est. primary completion date: April 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Effect of Drugs
• Macular Edema
• Uveitis
• Vascular Endothelial Growth Factor

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital (PUMCH)	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Bethune public welfare fund

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of best corrected visual acuity (BCVA)	changes from baseline BCVA at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)	baseline and at 1, 2, 3, 4, 5, 6 months after injection
Primary	Changes of central retinal thickness (CRT)	changes from baseline CRT at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)	baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary	changes of concentration of inflammatory cytokines	inflammatory cytokines include VEGF-A, VEGF-B, interleukin (IL)-2, interleukin-6, interleukin-8, interleukin-10, interleukin-12, tumor necrosis factor (TNF) a, monocyte chemotactic protein-1 and macrophage inflammatory protein-1	before injection (baseline), 1 month after the first injection, at the end of the study (6 months)
Secondary	inflammatory status	changes from baseline flare and cells in the anterior chamber at 1, 2, 3, 4, 5, 6 months after injection	baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary	side effects of the eye: increase of intraocular pressure	changes from baseline intraocular pressure at 1, 2, 3, 4, 5, 6 months after injection	baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary	side effects of the eye: development/exacerbation of cataract	whether cataract is developed or exacerbated	baseline and at 1, 2, 3, 4, 5, 6 months after injection