Safety and Efficacy of DE-109 injection in patients with active, non-infectious inflammation of middle layer of the eye
Phase 3
- Conditions
- Health Condition 1: null- Active, Non-Infectious Uveitis of the Posterior Segment of the eyeHealth Condition 2: H208- Other iridocyclitis
- Registration Number
- CTRI/2011/12/002309
- Lead Sponsor
- Santen Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. Ability to give informed consent and attend all study visits
2. Males or females greater than or equal to 18 years of age
3. Have diagnosis of active uveitis determined by the Investigator to be non-infectious based on
the subject?s medical history, history of present illness, ocular examination, review of
systems, physical examination, and any relevant, pertinent laboratory evaluations. If an
anterior component is present, it must be less than the posterior component
4. Have active uveitis defined as having 1+ (excluding 1+) vitreous haze score (SUN scale)
5. Best-corrected ETDRS visual acuity letter score of 19 letters or more (20/400 Snellen
equivalent) or better in study eye
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method