Phase 3
N=229
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
Intermediate Uveitis · Posterior Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT00333814 ↗Enrolled (actual)
229
Serious AEs
8.0%
Results posted
Apr 2011
Primary outcome: Primary: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero — 35.5; 46.8; 11.8 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero |
35.5; 46.8; 11.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00333814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.