A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

Phase 3

Completed

• Conditions: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis
• Interventions: Drug: Placebo; Drug: LX211

• Registration Number: NCT00404612
• Lead Sponsor: Lux Biosciences, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-29
• Study Start: 2007-01
• Primary Completion: 2008-11
• Study Completion: 2009-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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:

  1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
  2. 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
  3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
  4. 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
  5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
LX211, 0.4 mg/kg	LX211	-
LX211, 0.2 mg/kg	LX211	-
LX211, 0.6 mg/kg	LX211	-

Primary Outcome Measures

Name	Time	Method
vitreous haze	16 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
BCVA	24 weeks

Trial Locations

Locations (40)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

University of Illinois - Chicago; 🇺🇸 Chicago, Illinois, United States

Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

Massachusetts Eye Research and Surgery Institute; 🇺🇸 Cambridge, Massachusetts, United States

Associated Retinal Consultants, PC; 🇺🇸 Grand Rapids, Michigan, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

UMDNJ-New Jersey Medical School, Ophthalmology Dept.; 🇺🇸 Newark, New Jersey, United States

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