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

Posterior Uveitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333814
• Other study ID #: 206207-014
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 2, 2006
• Last updated: March 11, 2011
• Start date: May 2006
• Est. completion date: April 2009

Study information

• Verified date: March 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermediate Uveitis
• Posterior Uveitis
• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• Dexamethasone
Dexamethasone 350 µg; injection drug delivery system at Day 0
• dexamethasone
Dexamethasone 700 µg injection drug delivery system at Day 0
• Sham injection
Sham injection at Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Greece,  India,  Israel,  Korea, Republic of,  Poland,  Portugal,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero	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).	Week 8	No

External Links

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