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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04296838
Other study ID # BJ-LM2018010J
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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