Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT01232920
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 (\<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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01232920
Study Brief:
Protocol Section:
NCT01232920