Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Carsten Heinz

Status and phase: Completed; Phase 2

Conditions: Uveitis

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00803816

2006-004876-10

Details and patient eligibility

About

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

Full 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)

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Addition of everolimus to standard care

Other group

Description:

refractive to cyclosporine A (CsA) received additional everolimus.

Treatment:

Drug: everolimus