Simvastatin in Uveitis

Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Status and phase: Completed; Phase 2

Conditions: Uveitis

Treatments: Drug: Simvastatin 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04183387

SMV003

Details and patient eligibility

About

The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.

Full description

3-Hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors (statins) have been shown to reduce local and systemic inflammation in animal models of various autoimmune disorders including uveitis. In this open-label, randomized study clinical efficacy and tolerability of simvastatin 40 mg/day for 8 weeks is evaluated.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of active non-infectious uveitis

Exclusion criteria

• serious liver or kidney disease
• increased transaminase levels of >1.5 ULN
• planned or active pregnancy
• use of fibrates, nicotinic acid, cyclosporine A, antifungal drugs, macrolide antibiotics, verapamil, and grapefruit juice (>1 L/day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Simvastatin and standard treatment

Experimental group

Description:

40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis

Treatment:

Drug: Simvastatin 40mg

standard treatment

No Intervention group

Description:

conventional treatment of uveitis