Study of FTY720 in Patients With Uveitis

NCT01791192 | Withdrawn Phase 2

• 2 other identifiers: CFTY720D22052011-004160-30
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Noninfectious Posterior, Intermediate, or Pan Uveitis

Keywords

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

Outcome Measures

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.

  Day 8

Secondary Outcomes (5)

• Change in Vitreous Haze Score in the Study Eye on Study Examination Days

  Days 2, 4, 29, 57

• Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days

  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

  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.

  Days 2, 4, 8, 29 and 57

• Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days

  Days 2, 29 and 57

Study Arms (2)

FTY720

EXPERIMENTAL

Fingolimod

Drug: FTY720

Oral Corticosteroid

ACTIVE COMPARATOR

Oral Corticosteroid

Drug: Oral Corticosteroid

Interventions

FTY720 DRUG

Fingolimod

FTY720

Oral Corticosteroid DRUG

Oral Corticosteroid

Oral Corticosteroid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Acute noninfectious posterior, intermediate, or pan uveitis
• Vitreous haze score of 1+ or more in the study eye at screening and baseline visits

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Uveitis; Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Fingolimod Hydrochloride; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 13, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 20, 2017

Record last verified: 2014-04