ClinicalTrials.gg
WithdrawnNCT01791192Updated Apr 20, 2017

Study of FTY720 in Patients With Uveitis

A Phase 2 interventional study of FTY720 and Oral Corticosteroid in Acute Noninfectious Posterior, Intermediate, or Pan Uveitis, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-20.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Uveitis by Novartis — none open to participants now, none under way, none of them phase 3. Uveitis · Novartis.

Enrollment
8th of 10
0 · median 45
Started
2013
the only one that year
Phase 2
3 of 11
none open now
Registered
10th of 11
by date

Among the 11 studies in Uveitis by Novartis, this one is the 8th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2013, is one of 3 in phase 2, and was the 10th registered.

Uveitis

299 studies on the registry are indexed under Uveitis; 32 are open to participants now.

Browse Uveitis studies →

Open to participants now

None of the 11 studies in Uveitis by Novartis is open now. The open studies under Uveitis, anywhere →

Who these studies take

Of the 22 Uveitis studies recruiting now, 13 (59%) set no upper age limit and 9 (41%) stop at 75 or younger; 10 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 11 studies in Uveitis by Novartis as a file.
02

Study summary

This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis

03

Conditions studied

  • Acute Noninfectious Posterior, Intermediate, or Pan Uveitis

Keywords

  • Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Vaso-occlusive vasculitis involving the retinal macula
  • Behçet's uveitis
  • Patients requiring or another systemic medication for any other disease (e.g., asthma or some other disease) that would contraindicate tapering (topical steroids permitted)
  • Other protocol defined inclusions and/or exclusions may apply.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    FTY720

    Fingolimod

    Drug: FTY720

  • Active comparator
    Oral Corticosteroid

    Oral Corticosteroid

    Drug: Oral Corticosteroid

Interventions

  • DrugFTY720

    Fingolimod

  • DrugOral Corticosteroid

    Oral Corticosteroid

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 8

Secondary outcomes

  1. 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.

    Time frame: Days 2, 4, 29, 57

  2. 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.

    Time frame: Days 2, 4, 8, 29 and 57

  3. 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.

    Time frame: Days 2, 4, 8, 29 and 57

  4. 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).

    Time frame: Days 2, 4, 8, 29 and 57

  5. 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.

    Time frame: Days 2, 29 and 57

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2013
First posted
Feb 13, 2013
Start
Nov 2013
Primary completionEst.
Oct 2014
CompletionEst.
Oct 2014
Last update
Apr 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01791192
Responsible party
Sponsor
First posted
Feb 13, 2013
Start date
Nov 2013
Primary completion
Oct 2014 (estimated)
Completion
Oct 2014 (estimated)
Last update
Apr 20, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Fingolimod

Start the discussion