Acute Noninfectious Posterior, Intermediate, or Pan UveitisPhase 2NCT01791192
Study of FTY720 in Patients With Uveitis
A Phase 2 study testing FTY720 and Oral Corticosteroid in people with Acute Noninfectious Posterior, Intermediate, or Pan Uveitis, run by Novartis Pharmaceuticals.
Trial summary
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
- What is being tested?
- FTY720 and Oral Corticosteroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute noninfectious posterior, intermediate, or pan uveitis
- Vitreous haze score of 1+ or more in the study eye at screening and baseline visits
Who cannot join
- 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.
About this study
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
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
- Being tested
- FTY720, Oral Corticosteroid
- Keywords
- Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
- Medical subject headings
- Uveitis, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTY720Drug
Fingolimod
Oral CorticosteroidDrug
Oral Corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| FTY720 | Experimental | Fingolimod Receives: Drug: FTY720 |
| Oral Corticosteroid | Active comparator | Oral Corticosteroid Receives: Drug: Oral Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 8
Secondary outcomes (5)
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.
Measured: Days 2, 4, 29, 57
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.
Measured: 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
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.
Measured: 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.
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).
Measured: Days 2, 4, 8, 29 and 57
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.
Measured: Days 2, 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Noninfectious Posterior, Intermediate, or Pan UveitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791192
- Sponsor's protocol ID
- CFTY720D2205
- Other IDs
- 2011-004160-30
- Status last verified
- Apr 2014
- First submitted
- 12 Feb 2013
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01791192
- Acronym / sponsor ID
- CFTY720D2205
- Keywords
- Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTY720 | Experimental | Drug: FTY720Fingolimod |
| Oral Corticosteroid | Active comparator | Drug: Oral CorticosteroidOral Corticosteroid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Acute noninfectious posterior, intermediate, or pan uveitis
- Vitreous haze score of 1+ or more in the study eye at screening and baseline visits
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTY720Fingolimod | Drug | FTY720 |
| Oral CorticosteroidOral Corticosteroid | Drug | Oral Corticosteroid |
Primary outcome
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.
5 secondary outcomes
Change in Vitreous Haze Score in the Study Eye on Study Examination Days
Time frame: 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
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
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
Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days
Time frame: Days 2, 29 and 57
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FTY720 and Oral Corticosteroid in people with Acute Noninfectious Posterior, Intermediate, or Pan Uveitis, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vitreous Haze Score in the Study Eye at Day 8 (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.