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Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Primary Purpose

Uveitis, Macular Edema, Vascular Endothelial Growth Factor

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
intravitreal injection of Conbercept
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Uveitis, Macular Edema, vascular endothelial growth factor, aqueous humor, Effect of Drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking Union Medical College Hospital (PUMCH)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

refractory UME patients treated with Conbercept

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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) α, monocyte chemotactic protein-1 and macrophage inflammatory protein-1
inflammatory status
changes from baseline flare and cells in the anterior chamber at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: increase of intraocular pressure
changes from baseline intraocular pressure at 1, 2, 3, 4, 5, 6 months after injection
side effects of the eye: development/exacerbation of cataract
whether cataract is developed or exacerbated

Full Information

First Posted
January 1, 2020
Last Updated
October 24, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Bethune public welfare fund
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1. Study Identification

Unique Protocol Identification Number
NCT04296838
Brief Title
Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF
Official Title
Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible
Study Start Date
October 12, 2019 (Actual)
Primary Completion Date
April 12, 2020 (Actual)
Study Completion Date
February 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Bethune public welfare fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Macular Edema, Vascular Endothelial Growth Factor, Effect of Drugs
Keywords
Uveitis, Macular Edema, vascular endothelial growth factor, aqueous humor, Effect of Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
refractory UME patients treated with Conbercept
Arm Type
Experimental
Arm Description
patients in this arm should meet the inclusion criteria and the definition of refractory UME
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of Conbercept
Other Intervention Name(s)
Lumitin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of best corrected visual acuity (BCVA)
Description
changes from baseline BCVA at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
Time Frame
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Title
Changes of central retinal thickness (CRT)
Description
changes from baseline CRT at 1, 2, 3, 4, 5, 6 months after injection (at each follow-up visit)
Time Frame
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary Outcome Measure Information:
Title
changes of concentration of inflammatory cytokines
Description
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
Time Frame
before injection (baseline), 1 month after the first injection, at the end of the study (6 months)
Title
inflammatory status
Description
changes from baseline flare and cells in the anterior chamber at 1, 2, 3, 4, 5, 6 months after injection
Time Frame
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Title
side effects of the eye: increase of intraocular pressure
Description
changes from baseline intraocular pressure at 1, 2, 3, 4, 5, 6 months after injection
Time Frame
baseline and at 1, 2, 3, 4, 5, 6 months after injection
Title
side effects of the eye: development/exacerbation of cataract
Description
whether cataract is developed or exacerbated
Time Frame
baseline and at 1, 2, 3, 4, 5, 6 months after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking Union Medical College Hospital (PUMCH)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

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Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

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