Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Phase 2

Terminated

• Conditions: Effect of Drugs; Uveitis; Macular Edema; Vascular Endothelial Growth Factor
• Interventions: Drug: intravitreal injection of Conbercept

• Registration Number: NCT04296838
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Study Start: 2019-10-12
• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Primary Completion: 2020-04-12
• Study Completion: 2022-02-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
refractory UME patients treated with Conbercept	intravitreal injection of Conbercept	patients in this arm should meet the inclusion criteria and the definition of refractory UME

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital (PUMCH); 🇨🇳 Beijing, Beijing, China