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Completed

NCT Number: NCT00404885

A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

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

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Key information

Conditions

Uveitis, Anterior Eye Diseases Inflammation Panuveitis Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases Uveitis

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 anterior, anterior and intermediate- or panuveitis
  • Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated.
  • Grade of 2+ or higher for anterior chamber cells at time of enrollment
  • Considered by the investigator to require corticosteroid-sparing therapy.
  • Subjects not planning to undergo elective ocular surgery during the study

Exclusion criteria

  • Uveitis of infectious etiology
  • Presence of an ocular toxoplasmosis scar
  • An immune suppression regimen that includes an alkylating agent within the previous 90 days

Treatment and study plan

Placebo

Drug

PO BID

LX211

Drug

0.2 mg/kg, twice a day (BID)

Primary outcomes

  1. anterior chamber cells

    Time frame: 16 and 24 weeks

Secondary outcomes

  1. BCVA

    Time frame: 24 weeks

  2. macular thickness

    Time frame: 16 and 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 Anterior 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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