Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2008 by St. Franziskus Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

St. Franziskus Hospital

ClinicalTrials.gov Identifier:

NCT00803816

First received: December 5, 2008

Last updated: NA

Last verified: December 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 5, 2008
Last Updated Date	December 5, 2008
Start Date ^ICMJE	November 2007
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 5, 2008)	Inactivity of uveitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 5, 2008)	Reoccurence of uveitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Official Title ^ICMJE	Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
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)
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uveitis
Intervention ^ICMJE	Drug: everolimus everolimus 1.0 - 2.5mg oral daily dosage
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	12
Estimated Completion Date	December 2010
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00803816
Other Study ID Numbers ^ICMJE	2006-004876-10
Has Data Monitoring Committee	Yes
Responsible Party	Prof. Dr. A Heiligenhaus, Department of Ophthalmolgy at St Franziskus Hospital
Study Sponsor ^ICMJE	St. Franziskus Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	St. Franziskus Hospital
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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