Etanercept Versus Placebo in Ocular Manifestations of Behcet's Disease, a single Blind Controlled trial
Phase 4
- Conditions
- Ocular involvement in Behcet's disease.behcet's disease
- Registration Number
- IRCT138901292641N2
- Lead Sponsor
- Tehran University Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Inclusion Criteria: Behcet's Disease according to the International Criteria for Behcet's disease (ICBD), Active posterior uveitis and/or retinal vasculitis
Exclusion Criteria
Visual acuity inferior to 1/10 on Snellen chart, Being under cytotoxic drugs or having received them in the past 2 months, Not being able to follow the one year treatment and the regular follow ups
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inflammatory Activity Index. Timepoint: 2 months. Method of measurement: Total Inflammatory Activity Index.;Visual acuity. Timepoint: 2 months. Method of measurement: Total Inflammatory Activity Index.
- Secondary Outcome Measures
Name Time Method Total Inflammatory Activity Index (TIAI). Timepoint: 2 months. Method of measurement: ophtalmologist's record.;Visual acuity. Timepoint: 2 months. Method of measurement: ophtalmologist's record.;Disease activity index for anterior uveitis. Timepoint: 2 months. Method of measurement: ophtalmologist's record.;Retinal vasculitis. Timepoint: 2 months. Method of measurement: ophtalmologist's record,Top con TR angiography 50S, skiascopy,ocular coherenttomography.;Total Adjusted Disease Activity Index (TADAI). Timepoint: 2 months. Method of measurement: ophtalmologist's record.;Disease activity index for posterior uveitis. Timepoint: 2 months. Method of measurement: ophtalmologist's record.