Uveitis Clinical Trial
— FASTOfficial title:
First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial
The proposed study is a masked trial, with stratified block randomization by site, designed
to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as
first-line steroid-sparing treatment for patients with non-infectious uveitis requiring
corticosteroid-sparing therapy.
One hundred non-infectious uveitis patients in need of corticosteroid-sparing therapy will
be randomized to receive either oral methotrexate or oral mycophenolate mofetil at Aravind
Eye Hospitals (Madurai and Coimbatore, South India). They will be followed monthly for 6
months after enrollment or until treatment failure. The investigators hypothesize that the
proportion achieving corticosteroid-sparing success at 6 months for patients taking
mycophenolate mofetil will be improved in comparison with patients taking methotrexate.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Non-infectious anterior, intermediate, posterior or panuveitis - Active uveitis within the last 60 days (defined by the presence of any of the following according to SUN criteria: = 1+ anterior chamber cells, anterior vitreous cells, vitreous haze, active retinal or choroidal lesions) - Prednisone dose = 15 mg/day - History of corticosteroid taper failure (inability to taper to prednisone 10 mg or less) or obvious chronic disease necessitating corticosteroid-sparing immunosuppressive treatment Exclusion Criteria: - Any infectious cause of uveitis - Tuberculosis: Evidence of active TB (PPD and CXR required - latent TB patients are still eligible) - Positive for Hepatitis: HBsAg and/or Hep C antibody - Positive for Syphilis: RPR/VDRL and/or FTA-ABS - Abnormal CBC (<2500 WBC or <75,000 Plts or <10 Hgb) - Abnormal liver and/or kidney tests (ALT/AST >2x normal or CR>1.5) - Pregnancy or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal) - Chronic hypotony (IOP < 5 mm Hg for > 3 months) - Prior use of any immunosuppressive drug for the treatment of uveitis in the past 6 months - Prior failed treatment with methotrexate or mycophenolate mofetil - Periocular or intravitreal corticosteroid injection in the past 3 months - Fluocinolone acetonide implant surgery in either eye in < 3 years - Intraocular surgery in < 30 days, or any ocular surgery scheduled during the 6-month study period - VA of hand motions or worse in better eye - < 16 years of age at enrollment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Aravind Eye Hospital | Coimbatore | Tamil Nadu |
India | Aravind Eye Hospital | Madurai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Aravind Eye Hospitals, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion Achieving Overall Treatment Success at 6 Months. | TREATMENT SUCCESS is defined as controlled ocular inflammation in both eyes with less than or equal to 10 mg/day of prednisone and/or 2 topical steroid drops/day sustained for 2 visits separated by at least 28 days (control of inflammation and prednisone dose must be achieved by 5-month visit and sustained until 6-month visit). Discontinuation of study medication at any time due to efficacy, tolerability, or safety may result in a declaration of TREATMENT FAILURE. Note that all patients will be classified as either a treatment success or failure. |
6 months | No |
Secondary | Time to Control of Inflammation | 6 months | No | |
Secondary | Proportion Achieving Treatment Success and Complete Discontinuation of Corticosteroids | 6 months | No | |
Secondary | Change in Best Spectacle-corrected Visual Acuity (BSCVA) | 6 months | No | |
Secondary | Rate of Discontinuation Due to Intolerability | 6 months | No | |
Secondary | Rate of Adverse Events | 6 months | Yes | |
Secondary | Change in Health- and Vision-related Quality of Life, as Measured by SF-36 and IND-VFQ-33 Respectively | 6 months | No | |
Secondary | Change in Cystoid Macular Edema (CME) | 6 months | No |
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