Back to resultsStudy of FTY720 in Patients With Uveitis
Primary Purpose
Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FTY720
Oral Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Acute Noninfectious Posterior, Intermediate, or Pan Uveitis focused on measuring Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FTY720
Oral Corticosteroid
Arm Description
Fingolimod
Oral Corticosteroid
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT01791192
First Posted
February 12, 2013
Last Updated
April 19, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01791192
Brief Title
Study of FTY720 in Patients With Uveitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
Keywords
Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FTY720
Arm Type
Experimental
Arm Description
Fingolimod
Arm Title
Oral Corticosteroid
Arm Type
Active Comparator
Arm Description
Oral Corticosteroid
Intervention Type
Drug
Intervention Name(s)
FTY720
Intervention Description
Fingolimod
Intervention Type
Drug
Intervention Name(s)
Oral Corticosteroid
Intervention Description
Oral Corticosteroid
Primary Outcome Measure Information:
Title
Change in Vitreous Haze Score in the Study Eye at Day 8
Description
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
Secondary Outcome Measure Information:
Title
Change in Vitreous Haze Score in the Study Eye on Study Examination Days
Description
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
Title
Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days
Description
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
Title
Changes in Macular Thickness (Thickness at the Center of the Retina) in the Right and Left Eyes on Study Examination Days
Description
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
Title
Measures of the Safety and Tolerability of the Study Medication FTY720; Also Measures of Whether the Patients Required Rescue Medication for their Uveitis.
Description
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
Title
Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study of FTY720 in Patients With Uveitis
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