Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

NCT ID: NCT00803816

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

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)

Conditions

Uveitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Addition of everolimus to standard care

refractive to cyclosporine A (CsA) received additional everolimus.

Group Type: OTHER

everolimus

Intervention Type: DRUG

everolimus 1.0 - 2.5mg oral daily dosage

Interventions

everolimus

everolimus 1.0 - 2.5mg oral daily dosage

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carsten Heinz

OTHER

Sponsor Role: lead

Responsible Party

Carsten Heinz

Prof Heiligenhaus Head of Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arnd Heiligenhaus, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology at St. Franziskus Hospital

Locations

Department of Ophthalmology at St. Franziskus Hospital

Münster, , Germany

Countries

Germany

Other Identifiers

2006-004876-10

Identifier Type: -

Identifier Source: org_study_id