Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A - Full Text View

Sponsored by:	St. Franziskus Hospital
Information provided by:	St. Franziskus Hospital
ClinicalTrials.gov Identifier:	NCT00803816

Purpose

Study efficacy of everolimus on course of uveitis:

Condition	Intervention	Phase
Uveitis	Drug: everolimus	Phase II

Drug Information available for: Cyclosporin Cyclosporine Everolimus

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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

St. Franziskus Hospital

More Information

Responsible Party:	Department of Ophthalmolgy at St Franziskus Hospital ( Prof. Dr. A Heiligenhaus )
Study ID Numbers:	2006-004876-10
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00803816
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Franziskus Hospital:

endogoneous
posterior
intermediate

Study placed in the following topic categories:

Everolimus
Cyclosporine
Clotrimazole
Uveitis

Miconazole
Eye Diseases
Tioconazole
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Uveal Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents

Physiological Effects of Drugs
Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009