Simvastatin in Uveitis

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

Detailed Description
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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.

Official Title
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Open-label Randomized Study of Efficacy and Safety of Simvastatin in Uveitis

Conditions
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Uveitis

Intervention / Treatment
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* Drug: Simvastatin 40mg


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin and standard treatment<br>40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis | Drug: Simvastatin 40mg<br> <br> * Other names: simvastatin;|
| No Intervention: standard treatment<br>conventional treatment of uveitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of corticosteroid sparing control of ocular inflammation | Incident cases of corticosteroid sparing control of ocular inflammation will be defined using following criteria: ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions; and ≤10 mg of oral prednisone daily and ≤2 drops of prednisolone acetate 1% (or equivalent) a day; The patient should fullfill both criteria to be classified as having corticosteroid sparing control of ocular inflammation | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Assessment of visual acuity using the Golovin-Sivtsev table | Baseline, 4 weeks, 8 weeks | 
| Anterior chamber cells | The grades for anterior chamber cells were 0 (<1 cell), 0.5 (1-5 cells), 1 (6-15 cells), 2 (16-25 cells), 3 (26-50 cells), or 4 (>50 cells) | Baseline, 4 weeks, 8 weeks | 
| Anterior chamber flare | The grades are the following: 0 (none), 1+ (faint), 2+ (moderate (iris and lens details clear)), 3+ (marked (iris and lens details hazy)), 4+ (intense (fibrin or plastic aqueous) | Baseline, 4 weeks, 8 weeks | 
| Vitreous haze | Nussenblatt scale: 0 (no flare), 0.5+ (trace), 1+ (clear optic disc and vessels, hazy nerve fiber layer), 2+ (hazy optic disc and vessels), 3+ (optic disc visible), 4+ (optic disc not visible) | Baseline, 4 weeks, 8 weeks | 
| Intraocular pressure | Measured using Maklakov tonometer | Baseline, 4 weeks, 8 weeks | 
| Changes in tear IL-6 | Concentrations of IL-6 (pg/ml) in tear samples | Baseline, 8 weeks | 
| Changes in tear IL-8 | Concentrations of IL-8 (pg/ml) in tear samples | Baseline, 8 weeks | 
| Changes in tear IL-10 | Concentrations of IL-10 (pg/ml) in tear samples | Baseline, 8 weeks | 
| Changes in tear TNFα | Concentrations of TNFα (pg/ml) in tear samples | Baseline, 8 weeks | 
| Changes in tear IFN-γ | Concentrations of IFN-γ (pg/ml) in tear samples | Baseline, 8 weeks | 
| Incidence of corticosteroid sparing control of ocular inflammation | Incident cases of corticosteroid sparing control of ocular inflammation will be defined using following criteria: ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions; and ≤10 mg of oral prednisone daily and ≤2 drops of prednisolone acetate 1% (or equivalent) a day; The patient should fullfill both criteria to be classified as having corticosteroid sparing control of ocular inflammation | 4 weeks |