Mycophenolate sodium (Myfortic®) in the Treatment of Uveitis: a Pilot Study.

INTERVENTION: Product Name: Myfortic Pharmaceutical Form: Coated tablet INN or Proposed INN: Mycophenolic acid CAS Number: 24280‐93‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1440‐ Trade Name: Neoral Product Name: Neoral Pharmaceutical Form: Capsule* INN or Proposed INN: Ciclosporin CAS Number: 59865‐13‐3 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 5 mg/kg/day‐ Product Name: Prednison Pharmaceutical Form: Tablet INN or Proposed INN: prednisone CAS Number: 53‐03‐2 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 60 mg‐ CONDITION: Uveitis ; MedDRA version: 8.1 Level: LLT Classification code 10046851 Term: Uveitis PRIMARY OUTCOME: Main Objective: Assessment of therapeutic equality between Myfortic® and cyclosporine by ophthalmologic examinations including:; § Inflammatory response (cells and haze in anterior chamber/vitreous)21; § BCVA.; Primary end point(s): Therapeutic equality between Myfortic® and cyclosporine:; § Decrease of inflammatory response.; § Improvement of BVCA; ; Secondary Objective: Secondary endpoints ; § Cystoid macular edema; § Inflammatory markers22; § Adverse effects; § Total amount of steroids; § Time to relapse; INCLUSION CRITERIA: 1. Men or women = 18 years of age with non‐infectious bilateral sight‐threatening uveitis due to one of the inflammatory conditions listed below: a. Ocular sarcoidosis: a granulomatous uveitis with posterior inflammation in a patient in which sarcoidosis has been established by means of a biopsy, cytology, or a positive scan. A diagnosis of ocular sarcoidosis can also be established on the basis of a positive ACE/ lysozyme with evidence of anergy on more than one antigen challenge. b. Intermediate uveitis: patients with clinical features as defined by the IUSG23. However, it is important that the patient has no evidence of a systemic infection such as Lyme Borreliosis and that there is no history of neurological symptoms likely to be associated with multiple sclerosis. All patients with intermediate uveitis should have a negative MRI with gadolinium contrast, prior to being enrolled. c. Behçet’s syndrome: the international study group classification wil