Study Detail: Lux Uveitis
Summary : Study of Vocolosprin Soft Gel Capsules in the treatment of active noninfectious intermediate, posterior or pan-uveitis.
Basic Trial Information
Status: Pending Start-up for Dec 2010
Age: 18 or older
Sponsor: LuxBio Sciences
Protocol Number: LX211-11
Study Duration: 6 months
Active non-infectious uveitis involving the intermediate and/or posterior segment in at least one eye as evidenced by vitreous haze grade of at least 2+.
Must have current uveitis therapy which consists of Prednisone monotherapy between 10-40 mg/day for at least 2 weeks or Prednisone at any dose in addition to one immunomodulatory agent of either cyclosporine, tacrolimus, azathiprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks.
Visual Acuity of at least CF at one foot in both eyes
Uveitis limied to only the anterior segment
Confirmed or suspected infectious uveitis in either eye
Active infection in either eye
Proliferative or severe non-proliferative diabetic retinopathy in either eye
Neovascular or wet AMD in either eye
Abnormalities of the vitreo-retinal interface in the study eye thought to interfere with assessment
Multiple general health exclusionary criteria including but not limited to the following: renal and liver function abnormalities, severe anemia, prescence of certianinfectious diseases, elevated blood pressure, baseline ECG abnormalities and body weight of less than 84 pounds.
A Multi-center, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Vocolosporin as Therapy in Subjects with Active Noninfectious Intermediate, Posterior or Pan-uveitis.
Trial Contact Information
Site Locations: Beachwood or Middleburg Hts.
Study Coordinator: 216/831-5704 ext. 253