Uveitis, specially endogenous interemdiate and posterior uveitis MedDRA version: 8.1 Level: LLT Classification code 10046851 Term: Uveitis
Conditions
Interventions
Trade Name: Certican
Product Name: Certican
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,25-
Trade
Sponsors
Department of Ophthalmology at St. Franziskus Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: best corrected visual acuity in better eye 0,2 or better patients with chronic endogenous intermediate and posterior uveitis without systemic inflammable disease (morbus Behcet, Bechterew´s disease, sarcoidosis, systemic vaskulitides, other immune mediated diseases) age >= 18 years no quiescence in previous 3 months with prednisone at cushing level within 6 weeks, eventually combined with prednison acetate 1% or dexamethasone 0,1% eye drops at dosage of = 3 x daily and therapy with cyclosporine A at dosage of 3mg / kg / daily or more or prednisone related side effects indication to steroid sparing immunosuppression uveitis related vision threatening complications informed censent by patient negative pregnancy test effective contraceptation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 forms of uveitis,witout endogne genesis which do not need immunosuppressive therapie (pox uveitis, borreliosis uveitis, tuberculosis uveitis, leprosy uveitis, herpes uveitis, measles uveitis, roseola uveitis, histoplasmosis uveitis, myosen uveitis, toxoplasmosis uveitis, onxhozerosis uveitis, HIV Uveitis, Fuchs´Heterochromiezyklitis 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 pregnant and breastfeeding women participation to other trails
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study efficacy of everolimus on course of uveitis: o obtain quiescence of inflammation after start of treatment o duration to obtain quiescence of inflammation o number of patients with quiescence of inflammation;Secondary Objective: o occurence of new complications from uveitis o course of visual acuity (LogMAR): percentage of patients with visual loss of 10 or more numbers on ETDRS as compared to baseline o change of recurrence rate as compared to time before everolimus treatment o occurence of recurrence after obtaining remission with everolimus treatment o duration to occurence of recurrence o number of patients with recurrence o corticosparing effect from everolimus o number of patients without topical corticosteroids; number of patients with reduced topical corticosteroids (<3x/daily) o number of patients without systemic corticosteroids; number of patients with reduced systemic corticosteroids (<10mg/daily) o efficacy of uveitis within 12 months o maintenance of remission after withdrawel of everolimus treatment at 12 months o course of cystoid macula edema (FLA, OCT);Primary end point(s): inflammatory quiescence at 12 months preservation of best corrected visual acuity at 12 months | — |
Countries
Germany
Outcome results
None listed