A Phase 2 interventional study of Simvastatin 40mg in Uveitis, sponsored by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology. Completed at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology · Phase 2, Interventional, and Treatment
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.
345 studies on the registry are indexed under Uveitis; 38 are open to participants now.
This study's enrollment of 50 is above the median of 30 across 214 interventional studies indexed under Uveitis.
Browse Uveitis studies →Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- diagnosis of active non-infectious uveitis
Exclusion Criteria:
40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis
Drug: Simvastatin 40mg
conventional treatment of uveitis
Also known as: simvastatin
Incidence of corticosteroid sparing control of ocular inflammation
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
Time frame: 8 weeks
Visual acuity
Assessment of visual acuity using the Golovin-Sivtsev table
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 4 weeks, 8 weeks
Intraocular pressure
Measured using Maklakov tonometer
Time frame: Baseline, 4 weeks, 8 weeks
Changes in tear IL-6
Concentrations of IL-6 (pg/ml) in tear samples
Time frame: Baseline, 8 weeks
Changes in tear IL-8
Concentrations of IL-8 (pg/ml) in tear samples
Time frame: Baseline, 8 weeks
Changes in tear IL-10
Concentrations of IL-10 (pg/ml) in tear samples
Time frame: Baseline, 8 weeks
Changes in tear TNFα
Concentrations of TNFα (pg/ml) in tear samples
Time frame: Baseline, 8 weeks
Changes in tear IFN-γ
Concentrations of IFN-γ (pg/ml) in tear samples
Time frame: 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: 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
Time frame: 4 weeks
Plan to share: No
Ran from Sep 2014 to primary completion in Jan 2016, 16 months.
Of 22 phase 2 interventional studies under Uveitis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 49. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Simvastatin
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology