This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2\~0 weeks) ,Treatment period (1-22 weeks), Follow-up period, At the same time, plasma concentration will be determined
This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2\~0 weeks) : the inclusion and exclusion criteria were evaluated, and those meeting the criteria could enter the treatment period. Treatment period (1-22 weeks) : Eligible subjects with non-infectious uveitis were given an initial subcutaneous injection of 80 mg at week 1, followed by a subcutaneous injection of 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (a total of 12 doses). Follow-up period: Follow-up for safety and/or efficacy is recommended at 6, 12, 24, and 32 weeks after initiation of the study drug. A final visit will be made at 32 weeks. During the study, if the condition of the subjects or their symptoms and signs become worse, the investigator can adjust the use of drugs for uveitis other than study drugs according to the actual situation of the subjects. At the same time, plasma concentration will be determined before D1, D78 (week 12), and D162 (week 24); Immunogenicity analysis was performed before D1 administration, before D78 (week 12), before D162 (week 24) and before D218 (week 32)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
80 mg was given subcutaneously at week 1, followed by 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (12 doses).
Peking Union Medical College Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The second hospital of Jilin University
Jilin City, China
Duration of treatment failure
Duration of treatment failure at 6 weeks of treatment or between 6 and 24 weeks of treatment (treatment failure is defined as meeting at least one of the following conditions in at least one eye:
Time frame: 6\12\24week
treatment failure rate
Treatment failure rate at each visit point from first administration to 24 weeks.Treatment failure was defined as meeting at least one of the following conditions in at least one eye: newly active inflammatory choroiditis or retinal vasculopathy \[from baseline\]; The anterior chamber cell grading or vitreous opacity grading did not reach ≦0.5+ during the 6 weeks visit, or the optimal condition did not improve in all visits after 6 weeks. Best corrected visual acuity decreased by ≧15 letters compared to best condition
Time frame: 6/12/24week
Changes in ocular inflammation
changes in anterior chamber cell grade
Time frame: 6/12/24week
Changes in ocular inflammation
changes in vitreous turbidity
Time frame: 6/12/24week
Changes in ocular inflammation
changes in macular edema
Time frame: 6/12/24week
Changes in ocular inflammation
changes in central retinal thickness
Time frame: 6/12/24week
Changes in visual acuity
Changes in visual acuity
Time frame: 6/12/24week
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Tianjin Medical University Eye Hospital
Tianjin, China
Renmin Hospital of Wuhan University
Wuhan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Changes in visual function scale VFQ-25
Changes in visual function scale VFQ-25
Time frame: 6/12/24week