Clinical Trial: Study of FTY720 in Patients With Uveitis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Multicenter, Randomized, Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of FTY720 in Patients With Acute, Noninfectious Intermediate, Posterior and Pa

Brief Summary: This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change in Vitreous Haze Score in the Study Eye at Day 8 [ Time Frame: Day 8 ]

On day 8 of the study, the vitreous haze score will be measured in patients during a dilated fundus examination (using eye drops to enlarge the pupil of the eye). The ophthalmologist will examine the back of the eye to obtain this measure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Vitreous Haze Score in the Study Eye on Study Examination Days [ Time Frame: Days 2, 4, 29, 57 ]
    On study examination days, the vitreous haze score will be measured in patients during a dilated fundus examination (using eye drops to enlarge the pupil of the eye). The ophthalmologist will examine the back of the eye to obtain this measure.
  • Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days [ Time Frame: Days 2, 4, 8, 29 and 57 ]
    Change in visual acuity will be assessed in the right and left eyes using the ETDRS (early treatment diabetic retinopathy study) visual acuity charts. Change in acuity is defined as the change in the number of letters correctly read on each chart.
  • Changes in Macular Thickness (Thickness at the Center of the Retina) in the Right and Left Eyes on Study Examination Days [ Time Frame: Days 2, 4, 8, 29 and 57 ]
    Macular thickness will be measured using an OCT (optical coherence tomography or type of ultrasound of the eye) on the right and left eyes. This test measures how thick the retina is; the study measure is the thickness at the central part of the eye.
  • Measures of the Safety and Tolerability of the Study Medication FTY720; Also Measures of Whether the Patients Required Rescue Medication for their Uveitis. [ Time Frame: Days 2, 4, 8, 29 and 57 ]
    This will be determined by how safe the study medication FTY720 is determined to be, by how well tolerated it is by the patients and also by whether the patients needed rescue medication (e.g. other medication to treat their uveitis if the study drug was not effective during the time they received it).
  • Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days [ Time Frame: Days 2, 29 and 57 ]
    The blood FTY720 and FTY720-P concentrations will be measured by collection of 3 mL of blood taken from the patients during specified study examination visits.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: February 12, 2013
Date Started: November 2013
Date Completion: October 2014
Last Updated: April 19, 2017
Last Verified: April 2014