Macular Edema Clinical Trial
Official title:
Effectiveness of Conbercept in Treating Refractory Uveitic Macular Edema and the Changes of VEGF Levels in the Aqueous Humor
Verified date | October 2022 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | February 12, 2022 |
Est. primary completion date | April 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital (PUMCH) | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Beijing Bethune public welfare fund |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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) a, 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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