Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carsten Heinz, St. Franziskus Hospital
ClinicalTrials.gov Identifier:
NCT00803816
First received: December 5, 2008
Last updated: May 22, 2015
Last verified: May 2015

December 5, 2008
May 22, 2015
November 2007
September 2010   (final data collection date for primary outcome measure)
Inactivity of uveitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00803816 on ClinicalTrials.gov Archive Site
Reoccurence of uveitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
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

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)
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uveitis
Drug: everolimus
everolimus 1.0 - 2.5mg oral daily dosage
Addition of everolimus to standard care
refractive to cyclosporine A (CsA) received additional everolimus.
Intervention: Drug: everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00803816
2006-004876-10
Yes
Carsten Heinz, St. Franziskus Hospital
Carsten Heinz
Not Provided
Principal Investigator: Arnd Heiligenhaus, MD Department of Ophthalmology at St. Franziskus Hospital
St. Franziskus Hospital
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP