- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01791192
Study of FTY720 in Patients With Uveitis
April 19, 2017 updated by: Novartis Pharmaceuticals
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
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FTY720
Fingolimod
|
Fingolimod
|
Active Comparator: Oral Corticosteroid
|
Oral Corticosteroid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vitreous Haze Score in the Study Eye at Day 8
Time Frame: 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.
|
Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vitreous Haze Score in the Study Eye on Study Examination Days
Time Frame: 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.
|
Days 2, 4, 29, 57
|
Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days
Time Frame: 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.
|
Days 2, 4, 8, 29 and 57
|
Changes in Macular Thickness (Thickness at the Center of the Retina) in the Right and Left Eyes on Study Examination Days
Time Frame: 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.
|
Days 2, 4, 8, 29 and 57
|
Measures of the Safety and Tolerability of the Study Medication FTY720; Also Measures of Whether the Patients Required Rescue Medication for their Uveitis.
Time Frame: 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).
|
Days 2, 4, 8, 29 and 57
|
Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days
Time Frame: 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.
|
Days 2, 29 and 57
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
February 12, 2013
First Submitted That Met QC Criteria
February 12, 2013
First Posted (Estimate)
February 13, 2013
Study Record Updates
Last Update Posted (Actual)
April 20, 2017
Last Update Submitted That Met QC Criteria
April 19, 2017
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CFTY720D2205
- 2011-004160-30 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
-
Priovant Therapeutics, Inc.Active, not recruitingNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious Pan UveitisUnited States
-
AbbVieActive, not recruitingNon-infectious Intermediate Posterior- or Pan-uveitisChina
-
University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
-
Alumis IncActive, not recruitingUveitis, Intermediate | Noninfectious Panuveitis | Uveitis Posterior Non-InfectiousUnited States
-
Lux Biosciences, Inc.CompletedPanuveitis | Uveitis, Posterior | Uveitis, IntermediateUnited States, United Kingdom, Canada, Germany, Austria, France, India
-
Lux Biosciences, Inc.CompletedPanuveitis | Uveitis, Posterior | Uveitis, IntermediateUnited States, United Kingdom, Canada, Germany, Austria, France, India
-
Clearside Biomedical, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate Uveitis | Noninfectious UveitisUnited States
-
Bausch & Lomb IncorporatedCompletedNoninfectious Posterior UveitisUnited States
-
EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
-
Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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