Back to resultsEverolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Primary Purpose
Uveitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis focused on measuring endogoneous, posterior, intermediate
Eligibility 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
Sites / Locations
- Department of Ophthalmology at St. Franziskus Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Addition of everolimus to standard care
Arm Description
refractive to cyclosporine A (CsA) received additional everolimus.
Outcomes
Primary Outcome Measures
Inactivity of uveitis
Secondary Outcome Measures
Reoccurence of uveitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00803816
Brief Title
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Official Title
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carsten Heinz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
endogoneous, posterior, intermediate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Addition of everolimus to standard care
Arm Type
Other
Arm Description
refractive to cyclosporine A (CsA) received additional everolimus.
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Description
everolimus 1.0 - 2.5mg oral daily dosage
Primary Outcome Measure Information:
Title
Inactivity of uveitis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reoccurence of uveitis
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnd Heiligenhaus, MD
Organizational Affiliation
Department of Ophthalmology at St. Franziskus Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology at St. Franziskus Hospital
City
Muenster
ZIP/Postal Code
48145
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
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