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Completed

NCT Number: NCT00803816

Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Ophthalmology at St. Franziskus Hospital

Münster, 48145, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

everolimus 1.0 - 2.5mg oral daily dosage

Primary outcomes

  1. Inactivity of uveitis

    Time frame: 1 year

Secondary outcomes

  1. Reoccurence of uveitis

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Carsten Heinz

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 8, 2008
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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