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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study is designed to explore the use of Myfortic® in patients with steroid-refractory uveitis. The aim of the study will be to show the therapeutic effect of Myfortic® in managing uveitis patients.
This study is a single arm prospective evaluation in which patients with uveitis are treated with Myfortic® in a dose of 360 mg bid for six months. From day 0, Myfortic will be combined with 1 mg/kg prednisone. Prednisone will be tapered from week 1 based on the clinical findings of the ophthalmologist.
There will be no other stratification of patients. After the screening, patients will be treated with Myfortic® for 6 months. Patients will be seen at month 1, 3, and 6. Thereafter patients will be followed up at month 12. Efficacy and safety assessments will be performed at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myfortic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myfortic | Drug | Myfortic in uveitis |
|
Inclusion Criteria:
Men or women ≥ 18 years of age with corticosteroid-refractory uveitis due to one of the inflammatory conditions listed below:
Disease that is 5 years or less in duration, with a significant flare in the past 24 months requiring intensification of anti-inflammatory therapy (predsinolone). A significant flare is defined as a drop of 2 lines of vision on an ETDRS chart or equivalent, or increase in vitreous flare by 2 grades.
Visual acuity of 0.1 or better in at least one eye.
Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicidal cream, or surgical sterilization) for the duration of the study and should continue such precautions for 6 weeks after receiving the last administration.
The screening laboratory test results must meet the following criteria:
Must have a normal chest radiograph within 3 months prior to first therapy with no evidence of malignancy, infection or TB.
Patient must be able to adhere to the study visit schedule and other protocol requirements.
The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
Exclusion Criteria:
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About 40 patients with uveitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hwang Yih Shiou, MD | Contact | 886-3-3281200 | 8666 | yihshiou.hwang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hwang Yih Shiou, MD | CGMH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CGMH | Recruiting | Taoyuan County | Taiwan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye 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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| D005227 |
| Fatty Acids |
| D008055 | Lipids |