Phase 3
N=80
First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial
Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT01232920 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jan 2016
Primary outcome: Primary: Number of Participants Achieving Treatment Success — 24; 15 participants — p=0.09
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methotrexate (Drug); Mycophenolate mofetil (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Treatment Success |
24; 15 | 0.09 |
| SECONDARY Time to Control of Inflammation |
139; 124 | — |
| SECONDARY Change in Best Spectacle-corrected Visual Acuity (BSCVA) |
-0.26; -0.19 | — |
| SECONDARY Number of Eyes With Resolution of Macular Edema |
22; 13; 17; 7 | — |
Summary
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.
Eligibility Criteria
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 ( 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 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
Data sourced from ClinicalTrials.gov (NCT01232920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.