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Completed

NCT Number: NCT04183387

Simvastatin in Uveitis

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

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Key information

Conditions

Uveitis Eye Diseases Uveal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Laboratory of Clinical Immunopharmacology

Novosibirsk, 630047, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Simvastatin 40mg

Drug

Other names: simvastatin

Primary outcomes

  1. Incidence of corticosteroid sparing control of ocular inflammation

    Time frame: 8 weeks

    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 outcomes

  1. Visual acuity

    Time frame: Baseline, 4 weeks, 8 weeks

    Assessment of visual acuity using the Golovin-Sivtsev table

  2. Anterior chamber cells

    Time frame: 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)

  3. Anterior chamber flare

    Time frame: 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)

  4. Vitreous haze

    Time frame: 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)

  5. Intraocular pressure

    Time frame: Baseline, 4 weeks, 8 weeks

    Measured using Maklakov tonometer

  6. Changes in tear IL-6

    Time frame: Baseline, 8 weeks

    Concentrations of IL-6 (pg/ml) in tear samples

  7. Changes in tear IL-8

    Time frame: Baseline, 8 weeks

    Concentrations of IL-8 (pg/ml) in tear samples

  8. Changes in tear IL-10

    Time frame: Baseline, 8 weeks

    Concentrations of IL-10 (pg/ml) in tear samples

  9. Changes in tear TNFα

    Time frame: Baseline, 8 weeks

    Concentrations of TNFα (pg/ml) in tear samples

  10. Changes in tear IFN-γ

    Time frame: Baseline, 8 weeks

    Concentrations of IFN-γ (pg/ml) in tear samples

  11. Incidence of corticosteroid sparing control of ocular inflammation

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2019
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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