Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF
Keywords
Abstract
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.
Dates
| Last Verified: | 11/30/2019 |
| First Submitted: | 12/31/2019 |
| Estimated Enrollment Submitted: | 03/03/2020 |
| First Posted: | 03/04/2020 |
| Last Update Submitted: | 03/03/2020 |
| Last Update Posted: | 03/04/2020 |
| Actual Study Start Date: | 10/11/2019 |
| Estimated Primary Completion Date: | 04/30/2020 |
| Estimated Study Completion Date: | 09/30/2020 |
Condition or disease
Intervention/treatment
Drug: refractory UME patients treated with Conbercept
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: refractory UME patients treated with Conbercept patients in this arm should meet the inclusion criteria and the definition of refractory UME | Drug: refractory UME patients treated with Conbercept 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Changes of best corrected visual acuity (BCVA) [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
2. Changes of central retinal thickness (CRT) [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
Secondary Outcome Measures
1. changes of concentration of inflammatory cytokines [before injection (baseline), 1 month after the first injection, at the end of the study (6 months)]
2. inflammatory status [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
3. side effects of the eye: increase of intraocular pressure [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
4. side effects of the eye: development/exacerbation of cataract [baseline and at 1, 2, 3, 4, 5, 6 months after injection]
