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The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin and standard treatment | Experimental | 40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis |
|
| standard treatment | No Intervention | conventional treatment of uveitis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 40mg | Drug |
|
|
| 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:
The patient should fullfill both criteria to be classified as having corticosteroid sparing control of ocular inflammation | 8 weeks |
| 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) |
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Inclusion Criteria:
- diagnosis of active non-infectious uveitis
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Clinical Immunopharmacology | Novosibirsk | 630047 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32377822 | Derived | Shirinsky IV, Biryukova AA, Kalinovskaya NY, Shirinsky VS. Tear cytokines as potential biomarkers in non-infectious uveitis: post hoc analysis of a randomised clinical trial. Graefes Arch Clin Exp Ophthalmol. 2020 Aug;258(8):1813-1819. doi: 10.1007/s00417-020-04707-7. Epub 2020 May 6. |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| 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:
The patient should fullfill both criteria to be classified as having corticosteroid sparing control of ocular inflammation | 4 weeks |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |