Uveitis, intermediate
Conditions
Interventions
Product Name: fingolimod
Product Code: FTY720
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: FINGOLIMOD
Sponsors
Novartis Pharma Service AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent must be obtained before any assessment is performed. • Male and female subjects, age 18 to 60 years of age with active posterior, intermediate, or pan uvetis. • Vitreous haze score of 1+ or more in the study eye at screening and baseline visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusions: 1. Vaso-occlusive vasculitis involving the retinal macula 2. Behçet’s uveitis 3. A history of clinically significant macular edema in either eye within 8 weeks of the screening visit 4. Evidence of retinal or sub-retinal fluid on OCT consistent with macular edema of sufficient severity to reduce visual acuity. 5. A clinical history of multiple sclerosis (MS) 6. Patients receiving Class Ia or Class III antiarrhythmic drugs, beta blockers, calcium channel blockers; those with a low heart rate (HR), history of syncope, sick sinus syndrome, 2nd degree or higher conduction block, ischemic heart disease, or congestive heart failure 7. Patients requiring corticosteroid or another systemic immunosuppressive medication for any other disease (e.g., asthma or some other autoimmune disease) that would contraindicate tapering (topical steroids permitted) 8. Patients with a negative varicella zoster antibody titer 9. Patients who have been treated with > 20mg prednisone on any day within 3 weeks prior to screening 10. Patients with known, active malignancies, except for patients with cutaneous basal cell carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of FTY720 on vitreous haze at Day 8 in patients with acute noninfectious posterior, intermediate, or pan uveitis ;Secondary Objective: To assess the effect of FTY720 on vitreous haze at Days 2, 4, 29 and 57 in patients with acute noninfectious posterior, intermediate, or pan uveitis To assess the effect of FTY720 on Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity at Days 2, 4, 8, 29 and 57 in acute noninfectious posterior, intermediate, or pan uveitis To assess the effect of FTY720 on central sub-field macular thickness at Days 2, 4, 8, 29 and 57 in acute noninfectious posterior, intermediate, or pan uveitis To assess the effect of FTY720 on need for rescue medication in patients with acute noninfectious posterior, intermediate, or pan uveitis To assess the safety and tolerability of FTY720 in patients with acute noninfectious posterior, intermediate, or pan uveitis To measure the blood FTY720 and FTY720-P concentrations in patients with acute noninfectious posterior, intermediate, or pan uveitis ;Primary end point(s): vitreous haze ;Timepoint(s) of evaluation of this end point: Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ETDRS visual acuity, central sub-field macular thickness 2. need for rescue medication;Timepoint(s) of evaluation of this end point: Days 2, 4, 8, 29 and 57 | — |
Countries
Germany, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed