Uveitis
Conditions
Brief summary
The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.
Detailed 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.
Interventions
DRUGSimvastatin 40mg
Sponsors
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of corticosteroid sparing control of ocular inflammation | 8 weeks | Incident cases of corticosteroid sparing control of ocular inflammation will be defined using following criteria: 1. ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions; and 2. ≤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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tear TNFα | Baseline, 8 weeks | Concentrations of TNFα (pg/ml) in tear samples |
| Changes in tear IFN-γ | Baseline, 8 weeks | Concentrations of IFN-γ (pg/ml) in tear samples |
| Visual acuity | Baseline, 4 weeks, 8 weeks | Assessment of visual acuity using the Golovin-Sivtsev table |
| Anterior chamber cells | Baseline, 4 weeks, 8 weeks | 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) |
| Anterior chamber flare | Baseline, 4 weeks, 8 weeks | 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) |
| Changes in tear IL-10 | Baseline, 8 weeks | Concentrations of IL-10 (pg/ml) in tear samples |
| Intraocular pressure | Baseline, 4 weeks, 8 weeks | Measured using Maklakov tonometer |
| Changes in tear IL-6 | Baseline, 8 weeks | Concentrations of IL-6 (pg/ml) in tear samples |
| Changes in tear IL-8 | Baseline, 8 weeks | Concentrations of IL-8 (pg/ml) in tear samples |
| Incidence of corticosteroid sparing control of ocular inflammation | 4 weeks | Incident cases of corticosteroid sparing control of ocular inflammation will be defined using following criteria: 1. ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions; and 2. ≤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 |
| Vitreous haze | Baseline, 4 weeks, 8 weeks | 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) |
Countries
Russia
Outcome results
None listed