Effect of Drugs, Macular Edema, Uveitis, Vascular Endothelial Growth Factor
Conditions
Keywords
Uveitis, Macular Edema, vascular endothelial growth factor, aqueous humor, Effect of Drugs
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.
Interventions
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.
Sponsors
Beijing Bethune public welfare fund
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed