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Completed

NCT Number: NCT00404742

A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

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Key information

Conditions

Uveitis, Posterior Eye Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Intermediate

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinik für Augenheilkunde, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
  • Minimum prescribed therapy upon enrollment is one or more of the following:
  • systemic prednisone or equivalent averaging ≥ 10 mg/day
  • at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
  • at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
  • Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
  • Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34)
  • Subjects not planning to undergo elective ocular surgery during the study

Exclusion criteria

  • Evidence of active, uncontrolled non-infectious uveitis
  • Periocular administration of corticosteroids within the previous 6 weeks.
  • Uveitis of infectious etiology
  • Uncontrolled glaucoma
  • Clinically suspected or confirmed central nervous system or ocular lymphoma
  • History or diagnosis of Behçet's disease
  • Primary diagnosis of anterior uveitis

Treatment and study plan

Placebo

Drug

PO BID

LX211

Drug

0.2 mg/kg, twice a day (BID)

Primary outcomes

  1. recurrence of ocular inflammation

    Time frame: 26 weeks

Secondary outcomes

  1. BCVA

    Time frame: 26 weeks

  2. systemic corticosteroid usage

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Lux Biosciences, Inc.

Industry

Registry information

Official study title

A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

Acronym: LUMINATE

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 29, 2006
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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