Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carsten Heinz
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Sirolimus

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