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This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of Mycophenolate Mofetil, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with relapse VKH divided into two groups: Mycophenolate Mofetil therapy group and traditional therapy group.
For Mycophenolate Mofetil therapy group, an initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. Study participants will be followed for up to one year to determine efficacy and side effects.
According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of MMF in treatment of relapse VKH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil therapy Group | An initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. |
| |
| traditional therapy group | Patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | Glucocorticoid is started at a dose of 0.5-0.8 mg/kg/day, and 60 mg daily was the highest dose. Mycophenolate mofetilwas is started at a dose of 0.5-1.0g bid. |
| Measure | Description | Time Frame |
|---|---|---|
| Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. | The participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. | 24 weeks |
| Recurrence rate | The recurrence rates in Mycophenolate mofetil treatment group and control group | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit | Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells. |
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Inclusion Criteria:
Exclusion Criteria:
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VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaomin Zhang | Contact | +8613920023990 | xiaomzh@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| xiaomin Zhang | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| D014607 | Uveomeningoencephalitic Syndrome |
| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 24 weeks |
| Prednisone exposure | Cumulative prednisone dose and/or mean prednisone dose | 12 months |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |