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
  Purpose

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

Condition Intervention Phase
Uveitis
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Resource links provided by NLM:


Further study details as provided by St. Franziskus Hospital:

Primary Outcome Measures:
  • Inactivity of uveitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reoccurence of uveitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Addition of everolimus to standard care
refractive to cyclosporine A (CsA) received additional everolimus.
Drug: everolimus
everolimus 1.0 - 2.5mg oral daily dosage

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803816

Locations
Germany
Department of Ophthalmology at St. Franziskus Hospital
Muenster, Germany, 48145
Sponsors and Collaborators
Carsten Heinz
Investigators
Principal Investigator: Arnd Heiligenhaus, MD Department of Ophthalmology at St. Franziskus Hospital
  More Information

No publications provided

Responsible Party: Carsten Heinz, Prof Heiligenhaus Head of Department, St. Franziskus Hospital
ClinicalTrials.gov Identifier: NCT00803816     History of Changes
Other Study ID Numbers: 2006-004876-10
Study First Received: December 5, 2008
Last Updated: May 22, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Franziskus Hospital:
endogoneous
posterior
intermediate

Additional relevant MeSH terms:
Uveitis
Eye Diseases
Uveal Diseases
Cyclosporine
Cyclosporins
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015