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Due to inter-city travel restrictions for COVID-19, regular follow-up for most patients is not possible
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| Name | Class |
|---|---|
| Beijing Bethune public welfare fund | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| refractory UME patients treated with Conbercept | Experimental | patients in this arm should meet the inclusion criteria and the definition of refractory UME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal injection of Conbercept | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | before injection (baseline), 1 month after the first injection, at the end of the study (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH) | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| 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 |
| 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 |
| 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 |
| D012164 |
| Retinal Diseases |