Simvastatin in Uveitis

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183387
• Other study ID #: SMV003
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2019
• Source: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Simvastatin 40mg

Locations

Country	Name	City	State
Russian Federation	Laboratory of Clinical Immunopharmacology	Novosibirsk

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual acuity	Assessment of visual acuity using the Golovin-Sivtsev table	Baseline, 4 weeks, 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Intraocular pressure	Measured using Maklakov tonometer	Baseline, 4 weeks, 8 weeks
Secondary	Changes in tear IL-6	Concentrations of IL-6 (pg/ml) in tear samples	Baseline, 8 weeks
Secondary	Changes in tear IL-8	Concentrations of IL-8 (pg/ml) in tear samples	Baseline, 8 weeks
Secondary	Changes in tear IL-10	Concentrations of IL-10 (pg/ml) in tear samples	Baseline, 8 weeks
Secondary	Changes in tear TNFa	Concentrations of TNFa (pg/ml) in tear samples	Baseline, 8 weeks
Secondary	Changes in tear IFN-?	Concentrations of IFN-? (pg/ml) in tear samples	Baseline, 8 weeks
Secondary	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