A multicenter, randomized, active-controlled study to assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis - Efficacy and Safety of Fingolimod in patients with uveitis

ovartis Pharma Service AG0 个研究点目标入组 0 人开始时间: 2012年4月2日最近更新: 2019年12月10日

试验速览

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•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

•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

发起方

ovartis Pharma Service AG