Clinical trial NCT04296838: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Uveitis
Macular Edema
Vascular Endothelial Growth Factor
Effect of Drugs
Keywords: Uveitis
Macular Edema
vascular endothelial growth factor
aqueous humor
Effect of Drugs
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Bethune public welfare fund
First posted: 2020-03-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes of best corrected visual acuity (BCVA)
timeFrame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
measure: Changes of central retinal thickness (CRT)
timeFrame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
Secondary outcomes:
measure: changes of concentration of inflammatory cytokines
timeFrame: before injection (baseline), 1 month after the first injection, at the end of the study (6 months)
measure: inflammatory status
timeFrame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
measure: side effects of the eye: increase of intraocular pressure
timeFrame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
measure: side effects of the eye: development/exacerbation of cataract
timeFrame: baseline and at 1, 2, 3, 4, 5, 6 months after injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital (PUMCH)
state: Beijing
Study officials:
References: