Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
Conditions
Keywords
Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
Brief summary
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
Interventions
DRUGFTY720
Fingolimod
DRUGOral Corticosteroid
Oral Corticosteroid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Acute noninfectious posterior, intermediate, or pan uveitis * Vitreous haze score of 1+ or more in the study eye at screening and baseline visits
Exclusion criteria
* Vaso-occlusive vasculitis involving the retinal macula * Behçet's uveitis * 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) * Other protocol defined inclusions and/or exclusions may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vitreous Haze Score in the Study Eye at Day 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vitreous Haze Score in the Study Eye on Study Examination Days | 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 | 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 | 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. | 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 | 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. |
Outcome results
None listed