NCT00803816

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

December 5, 2008

Last Update Submit

May 22, 2015

Conditions

Uveitis

Keywords

endogoneousposteriorintermediate

Outcome Measures

Primary Outcomes (1)

  • Inactivity of uveitis

    1 year

Secondary Outcomes (1)

  • Reoccurence of uveitis

    2 years

Study Arms (1)

Addition of everolimus to standard care

OTHER

refractive to cyclosporine A (CsA) received additional everolimus.

Drug: everolimus

Interventions

everolimusDRUG

everolimus 1.0 - 2.5mg oral daily dosage

Addition of everolimus to standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology at St. Franziskus Hospital

Münster, 48145, Germany

Location

MeSH Terms

Conditions

Uveitis

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Arnd Heiligenhaus, MD

    Department of Ophthalmology at St. Franziskus Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof Heiligenhaus Head of Department

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

DE(1)