Vogt-Koyanagi-Harada Disease
Conditions
Interventions
Arm A:Conventional treatment
ArmB:Biological treatment
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Subjects of either sex aged >= 18 years at the time of signing the informed consent document. b. Diagnosed with Vogt-Koyanagi-Harada disease. See Diagnostic Criteria for Vogt-Koyanagi-Harada disease in Appendix I. c. An active disease status: Requiring chronic oral prednisone (>= 20 mg or equivalent) for the treatment for intraocular inflammation; And/OR having an active inflammation or having documented history of experiencing an active inflammation within the last 90 days as defined by the presence of at least one of the following parameters in either eye: (1)>= 2+ anterior chamber cells (See SUN criteria in Appendix II); (2)>= 2+ vitreous haze (See NEI/SUN criteria in Appendix III); (3)Presence of active inflammatory choroidal or retinal lesions detected by optical coherence tomography (OCT) or fluorescein fundus angiography (FFA). d. Media clarity, pupillary dilatation and subject cooperation judged by the study Investigator for proper viewing of the posterior segment in at least one eye. e. Able and willing to consistently use effective contraceptive methods in order to successfully prevent pregnancy. f. Able and willing to self-administer subcutaneous injections or have a qualified condition available to administer subcutaneous injections. g. Able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: a. Visual acuity of hand motions or worse in the better-seeing eye. b. Previous exposure to anti-TNF therapy. c. Using > 1 systemic immunosuppressive therapy (not including corticosteroids) within the last 28 days. d. Uncontrolled intraocular pressure with >= 2 glaucoma medications or evidence of optic nerve injury. e. Chronic hypotony (IOP 3 months) in both eyes. f. Received intraocular or periocular corticosteroids in the past 3 months. g. Received Ozurdex (dexamethasone implant) in the past 6 months. h. Received Retisert (glucocorticosteroid implant) within 3 years prior to the Screening. i. Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy. j. Neovascular/wet age-related macular degeneration. k. History of moderate to severe congestive heart failure (NYHA class III or IV) or recent cerebrovascular accident. l. Current or history of demyelinating disease such as multiple sclerosis. m.Malignancy or history of malignancy. n. White blood cells 1200 x 10^9/L at the Screening. p. Hemoglobin = 2 times the upper limit of normal for the lab at the Screening. r. Abnormal serum creatinine >= 2 times the upper limit of normal for the lab at the Screening. The above laboratory tests will be allowed to be repeated 1 time if, in the Investigators clinical judgment, there is a reasonable possibility of the repeat tests not meeting the exclusion values, and with concurrence from the Medical Monitor. s. Systemic or opportunistic fungal infection. t. Having active tuberculosis, HIV infection, syphilis, or hepatitis B or C based on laboratory data and clinical judgment by the study Investigator. u. Known active current or history of recurrent infections (including but not limited to herpes zoster, histoplasmosis, coccidiomycosis, but excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with intravenous injection or oral antibiotics within 4 weeks of the Screening. Beyond the tests listed above, the remainder of the work-up is at the discretion of the investigator and should be tailored to the clinical situation. Distinguishing between infectious and non-infectious uveitis is part of standard of care and should be dictated by the patients clinical exam, but at minimum, all patients must have testing for tuberculosis, syphilis and hepatitis prior to enrollment. v. Prior history of suicide attempt at any time in the subjects lifetime or major psychiatric illness requiring hospitalization within 3 years prior to the Screening. w. Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures. x. Scheduled surgery or other interventions that would interrupt the subjects participation in the study. y. Pregnancy or current breast-feeding. z. Enrolled in other clinical trials. aa.Any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the difference in mean Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA letter score at 26 weeks; | — |
Countries
China
Contacts
Public ContactPeizeng Yang
Chongqing Medical University
Outcome results
None listed