An Open Label Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade®) in the Treatment of Endogenous Uveitis or Vasculitis unresponsive to Standard Therapy.
Suspended
- Conditions
- Patients with endogenous uveitis or vasculitis (e.g. sarcoidosis, intermediate uveitis, Behcet’s, idiopathic ocular vasculitis, birdshot and VKH/sympathetic ophthalmia).
- Registration Number
- NL-OMON20017
- Lead Sponsor
- AMC Medical Research B.V., Prof. Dr. M.D. de Smet, Meibergdreef 9, 1105 AZ AMSTERDAM ZO, The Netherlands, +31 20 566 34 59
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
1. Men or women 18 years of age with non-infectious bilateral sight-threatening uveitis due to one of the inflammatory conditions listed below:
a. Ocular sarcoidosis;
Exclusion Criteria
1. Inability to visualize the fundus due to corneal or lenticular opacities;
2. Patients requiring ocular surgery within the initial 3 months of treatment, or who have had surgery in the prior 3 months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if infliximab 5 mg/kg bodyweight monotherapy at weeks 0, 2, 6, 14, 22, 30, 38 and 46 can allow patients with endogenous uveitis or vasculitis unresponsive to standard therapy, to taper their concomitant immunosuppressants, while maintaining or improving their visual acuity and not meet any of the exit criteria.
- Secondary Outcome Measures
Name Time Method 1. To Determine the number of weeks patients maintain their visual acuity and not meet any of the exit criteria, after infliximab discontinuation at week 46, in patients who did taper their concomitant immunosuppressants and in patients who did not taper their concomitant immunosuppressants;<br /><br>2. Determine the percentage of patients who meet the exit criteria during the first 46 weeks and during follow-up, in patients who did taper their concomitant immunosuppressants and in patients who did not taper their concomitant immunosuppressants;<br /><br>3. Determine the effect of infliximab on quality of life, as assessed by the SF-36;<br /><br>4. Determine the effect of infliximab on the quality of vision as assessed by the NEI-VFQ-25;<br /><br>5. Safety of infliximab.