A Phase 2 interventional study of FTY720 and Oral Corticosteroid in Acute Noninfectious Posterior, Intermediate, or Pan Uveitis, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
Exclusion Criteria:
Fingolimod
Drug: FTY720
Oral Corticosteroid
Drug: Oral Corticosteroid
Fingolimod
Oral Corticosteroid
Change in Vitreous Haze Score in the Study Eye at 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.
Time frame: Day 8
Change in Vitreous Haze Score in the Study Eye on Study Examination Days
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.
Time frame: Days 2, 4, 29, 57
Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days
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.
Time frame: Days 2, 4, 8, 29 and 57
Changes in Macular Thickness (Thickness at the Center of the Retina) in the Right and Left Eyes on Study Examination Days
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.
Time frame: Days 2, 4, 8, 29 and 57
Measures of the Safety and Tolerability of the Study Medication FTY720; Also Measures of Whether the Patients Required Rescue Medication for their Uveitis.
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).
Time frame: Days 2, 4, 8, 29 and 57
Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days
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.
Time frame: Days 2, 29 and 57
No study locations are listed for this record.
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Novartis Pharmaceuticals