Trial | NCT00803816  Report issue

Official Title

Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    everolimus ...

  • Study Participants

    12
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
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)
Study Started
Nov 30
2007
Primary Completion
Sep 30
2010
Study Completion
Dec 31
2010
Last Update
May 27
2015
Estimate

Drug everolimus

everolimus 1.0 - 2.5mg oral daily dosage

Addition of everolimus to standard care Other

refractive to cyclosporine A (CsA) received additional everolimus.

Criteria 

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
No Results Posted