Study of FTY720 in Patients With Uveitis

NCT ID: NCT01791192

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Acute Noninfectious Posterior, Intermediate, or Pan Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FTY720

Fingolimod

Group Type EXPERIMENTAL

FTY720

Intervention Type DRUG

Fingolimod

Oral Corticosteroid

Oral Corticosteroid

Group Type ACTIVE_COMPARATOR

Oral Corticosteroid

Intervention Type DRUG

Oral Corticosteroid

Interventions

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FTY720

Fingolimod

Intervention Type DRUG

Oral Corticosteroid

Oral Corticosteroid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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2011-004160-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CFTY720D2205

Identifier Type: -

Identifier Source: org_study_id

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