Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Study Overview
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Brief Summary
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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
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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)

Official Title
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Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Conditions
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Uveitis

Intervention / Treatment
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* Drug: everolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Addition of everolimus to standard care<br>refractive to cyclosporine A (CsA) received additional everolimus. | Drug: everolimus<br>* everolimus 1.0 - 2.5mg oral daily dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inactivity of uveitis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoccurence of uveitis |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posterior, intermediate, endogoneous