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Simvastatin in Uveitis

Primary Purpose

Uveitis

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Simvastatin 40mg
Sponsored by
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Laboratory of Clinical Immunopharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simvastatin and standard treatment

standard treatment

Arm Description

40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis

conventional treatment of uveitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual acuity
Assessment of visual acuity using the Golovin-Sivtsev table
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)
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)
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)
Intraocular pressure
Measured using Maklakov tonometer
Changes in tear IL-6
Concentrations of IL-6 (pg/ml) in tear samples
Changes in tear IL-8
Concentrations of IL-8 (pg/ml) in tear samples
Changes in tear IL-10
Concentrations of IL-10 (pg/ml) in tear samples
Changes in tear TNFα
Concentrations of TNFα (pg/ml) in tear samples
Changes in tear IFN-γ
Concentrations of IFN-γ (pg/ml) in tear samples
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

Full Information

First Posted
November 26, 2019
Last Updated
November 28, 2019
Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT04183387
Brief Title
Simvastatin in Uveitis
Official Title
Open-label Randomized Study of Efficacy and Safety of Simvastatin in Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin and standard treatment
Arm Type
Experimental
Arm Description
40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis
Arm Title
standard treatment
Arm Type
No Intervention
Arm Description
conventional treatment of uveitis
Intervention Type
Drug
Intervention Name(s)
Simvastatin 40mg
Other Intervention Name(s)
simvastatin
Primary Outcome Measure Information:
Title
Incidence of corticosteroid sparing control of ocular inflammation
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Assessment of visual acuity using the Golovin-Sivtsev table
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Anterior chamber cells
Description
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
Title
Anterior chamber flare
Description
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
Title
Vitreous haze
Description
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
Title
Intraocular pressure
Description
Measured using Maklakov tonometer
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Changes in tear IL-6
Description
Concentrations of IL-6 (pg/ml) in tear samples
Time Frame
Baseline, 8 weeks
Title
Changes in tear IL-8
Description
Concentrations of IL-8 (pg/ml) in tear samples
Time Frame
Baseline, 8 weeks
Title
Changes in tear IL-10
Description
Concentrations of IL-10 (pg/ml) in tear samples
Time Frame
Baseline, 8 weeks
Title
Changes in tear TNFα
Description
Concentrations of TNFα (pg/ml) in tear samples
Time Frame
Baseline, 8 weeks
Title
Changes in tear IFN-γ
Description
Concentrations of IFN-γ (pg/ml) in tear samples
Time Frame
Baseline, 8 weeks
Title
Incidence of corticosteroid sparing control of ocular inflammation
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Laboratory of Clinical Immunopharmacology
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32377822
Citation
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.
Results Reference
derived

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Simvastatin in Uveitis

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