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Completed

NCT Number: NCT00404612

A Study of LX211 in Active Sight Threatening, 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 active non-infectious uveitis

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Key information

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

  • Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis
  • Current uveitis therapy must conform to one of the following:
  • Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
  • Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
  • Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
  • Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
  • Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
  • Grade of 2+ or higher for vitreous haze at time of enrollment
  • Considered by the investigator to require immunomodulatory therapy.
  • Not planning to undergo elective ocular surgery during the study

Exclusion criteria

  • Uveitis of infectious etiology
  • Clinically suspected or confirmed central nervous system or ocular lymphoma
  • 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. vitreous haze

    Time frame: 16 and 24 weeks

Secondary outcomes

  1. BCVA

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Lux Biosciences, Inc.

Industry

Registry information

Official study title

A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active 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
Oct 11, 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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