Assessment of Safety , Clinical Efficacy with QLETLI in Non-infectious Uveitis (UV) (NCT05180526) | Clinical Trial Compass
UnknownPhase 4
Assessment of Safety , Clinical Efficacy with QLETLI in Non-infectious Uveitis (UV)
China60 participantsStarted 2021-12-27
Plain-language summary
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
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients voluntarily participated in the study and signed informed consent
* Aged between 18 and 70 (including threshold), male or female;
* Diagnosis of non-infectious intermediate, posterior, or total uveitis in at least one eye;
* Received maintenance therapy (oral prednisone 10-60mg/day or equivalent glucocorticoid for ≧2 weeks before screening, and no dose adjustment from screening to baseline;
* At baseline, at least one eye was diagnosed with active uveitis, presenting as meeting at least one of the following criteria: active inflammatory chorioretinal and/or inflammatory retinal vasculopathy; Cell grade of anterior chamber ≧2+; Degree of vitreous turbid ≧2+;
* Negative serum pregnancy test results of women of childbearing age during screening visits;
Exclusion Criteria:
* Patients with the following eye conditions:
* Patients with simple anterior uveitis;
* Uveitis with macular edema as the only manifestation;
* is confirmed or suspected infectious uveitis (including but not limited to the following causes of infectious uveitis, tuberculosis, cytomegalovirus, lyme disease, toxoplasmosis, human, T, Whipple's disease virus type 1 infection, herpes zoster virus and herpes simplex virus) or disguise syndrome (for example: eye trauma, lymphoma, malignant tumor, or surgery, etc.);
* Uncontrolled glaucoma, defined as intraocular pressure higher than 25 mmHg after drug treatment, or optic nerve damage;
* Best corrected visual acuity of less than 20 le…