A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

Phase 2

Completed

• Conditions: Intermediate Uveitis; Posterior Uveitis
• Interventions: Drug: dexamethasone; Drug: Sham injection

• Registration Number: NCT00333814
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-06
• Primary Completion: 2008-12
• Study Completion: 2009-04
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Results First Submitted: 2010-10-12
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-11
• Last Update Submitted: 2011-03-11
• Results First Posted: 2011-04-14
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

• 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria

• Uncontrolled systemic disease
• Any active ocular infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dexamethasone	Dexamethasone 350 µg
3	Sham injection	Sham
2	dexamethasone	Dexamethasone 700 µg

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero	Week 8	Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).