NCT00404885
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Uveitis, Anterior
- Sponsor
- Lux Biosciences, Inc.
- Enrollment
- 108
- Locations
- 30
- Primary Endpoint
- anterior chamber cells
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Intervention: Placebo
LX211, 0.2 mg/kg
Intervention: LX211
LX211, 0.4 mg/kg
Intervention: LX211
LX211, 0.6 mg/kg
Intervention: LX211
Outcomes
Primary Outcomes
anterior chamber cells
Time Frame: 16 and 24 weeks
Secondary Outcomes
- BCVA(24 weeks)
- macular thickness(16 and 24 weeks)
Study Sites (30)
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