Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Uveitis Clinical Trial

Official title:

Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803816
• Other study ID #: 2006-004876-10
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2008
• Last updated: May 22, 2015
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: St. Franziskus Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• everolimus
everolimus 1.0 - 2.5mg oral daily dosage

Locations

Country	Name	City	State
Germany	Department of Ophthalmology at St. Franziskus Hospital	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
Carsten Heinz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inactivity of uveitis		1 year	Yes
Secondary	Reoccurence of uveitis		2 years	No