A multi-center study to assess the safety, effectiveness and tolerance of a study drug FTY720 in patients with certain types of the eye disease uveitis (inflammation in the back of the eye).
- Conditions
- veitis, intermediateuveitis, posterioruveitis, pan.MedDRA version: 14.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-004160-30-GB
- Lead Sponsor
- ovartis Pharma Service AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method