Uveitis
Conditions
Keywords
endogoneous, posterior, intermediate
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 inflammation
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 rate as compared to time before everolimus treatment * occurence of recurrence after obtaining remission with everolimus treatment * duration to occurence of recurrence o number of patients with recurrence * corticosparing effect from everolimus * number of patients without topical corticosteroids; number of patients with reduced topical corticosteroids (\<3x/daily) * number of patients without systemic corticosteroids; number of patients with reduced systemic corticosteroids (\<10mg/daily) * efficacy of uveitis within 12 months * maintenance of remission after withdrawel of everolimus treatment at 12 months o course of cystoid macula edema (FLA, OCT)
Interventions
DRUGeverolimus
everolimus 1.0 - 2.5mg oral daily dosage
Sponsors
Carsten Heinz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inactivity of uveitis | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Reoccurence of uveitis | 2 years |
Countries
Germany
Outcome results
None listed