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XOMA 130 ACUTE UVEITIS

TRIAL DESCRIPTION SUMMARY:

Monthly sub-cutaneous injections into the abdomen with study drug (or placebo) to demonstrate the superiority of study drug compared to placebo in the treatment of uveitis.

BASIC TRIAL INFORMATION:


Phase:         III
Disease:      Active non-infectious intermediate, posterior or pan uveitis
Age:             18 or older 
Sponsor:     XOMA
Protocol #: X052130/CL3-78989-005
Status:        Currently Enrolling
Length:       15 months 

ELIGIBILITY CRITERIA:

Key Inclusion Criteria:

  1. Active non-infectious intermediate, posterior or pan-uveitis in at lease one eye
  2. Presence of > 2+ vitreous hazeETDRS 10-75 letters study eye and >35 letters in fellow eye (or mono vision)
  3. MUST BE on stable oral corticosteroids > 10 to < 25 mg/day at least 2 wks prior to first injectionOR/ANDStable regimen at least one systemic immunosuppressive med for uveitis: azathioprine < 2.5 mg/kg/day (trade names: Imuran, Azasan) cyclosporine < maximum tolerable dose (trade names: Sandimmune, Neoral, Restatsis,Gengraf) mycophenolate mofetil <3g/day (trade names: CellCept) mycophenolate sodium < 2.16 g/day tacrolimus< 0.15 mg/kg/day (trade names: Protopic, Prografand/or methotrexate < the maximum tolerable dose (trade name: Trexall, Rheumatrex)at least 3 months prior to screening with no change to dosage within 4 wks prior to first injection 
  4. Weight 88-264 pounds

Key Exclusion Criteria:

  1. Infectious uveitis & masquerade syndromesIsolated anterior uveitis
  2. Poor visualization of posterior segmentIOP > 25 or need for more than 3 IOP lowering drugs to keep IOP below 22
  3. Contraindication to mydriatics in either eye or presence of posterior synechiae

General Medical Exclusion: 

  1. Active TB or abnormal CXRKnown HIV, HepB or HepCHx/Sx of demyelinating disease
  2. Hx of malignancy within 5 years prior to first injection other than carcinoma in situ of the cervix or treated non-metastatic squamous or basal cell of the skin 
  3. Other inclusion/exclusion criteria per protocol to be screened by the Clinical Coordinator

 

STUDY TITLE:

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumabin the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis


TRIAL CONTACT INFORMATION:

Site: Beachwood or Middleburgh Heights
Study Coordinator: Contact: Dianne H or Susan
Phone:  216/831-5704 ext. 253