Status:
COMPLETED
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Lead Sponsor:
Carsten Heinz
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study efficacy of everolimus on course of uveitis: * obtain quiescence of inflammation after start of treatment * duration to obtain quiescence of inflammation * number of patients with quiescence of...
Detailed Description
occurence of new complications from uveitis * course of visual acuity (LogMAR): percentage of patients with visual loss of 10 or more numbers on ETDRS as compared to baseline * change of recurrence r...
Eligibility Criteria
Inclusion
- endogenous intermediate or posterior uveitis
- no quiesence in previous 3 months under systemic and topical steroids or systemic cyclosporine A
- indication for steroid sparing therapy
- uveitis related vision threating complications
- negative pregnancy test
- effective contraception
Exclusion
- Ophthalmic parameters:
- silicone oil in anterior chamber of both eyes para- or intraocular corticosteroid injections within previous 8 weeks
- opacities of optic media that obscure visualization of anterior or posterior eye segments
- General parameters:
- requirement for combined immunosuppression for systemic immune-mediated disease contraindication against everolimus or cyclosporine A
- positive tuberculine test (GT 10
- currently immunosuppressive therapy with immunosuppressive drug other than cyclosporine
- poor compliance
- known intolerance to medication
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00803816
Start Date
November 1 2007
End Date
December 1 2010
Last Update
May 27 2015
Active Locations (1)
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1
Department of Ophthalmology at St. Franziskus Hospital
Münster, Germany, 48145