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

Status Completed

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

Clinical Trial 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) ;

Study Design

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

Related Conditions & MeSH terms

• Uveitis

• NCT number: NCT00803816
• Study type: Interventional
• Source: St. Franziskus Hospital
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Completion date: December 2010