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UveitisPhase 2NCT04183387

Simvastatin in Uveitis

A Phase 2 study testing Simvastatin 40mg in people with Uveitis, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Uveitis
What is being tested?
Simvastatin 40mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteRussia
Study dates
Sep 2014to Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of active non-infectious uveitis

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Laboratory of Clinical Immunopharmacology

    Novosibirsk, 630047

Other trials in Russia

About this study

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

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

Read the 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.

Conditions
Uveitis
Being tested
Simvastatin 40mg
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simvastatin 40mgDrug

    Also called simvastatin

Study groups in NCT04183387
Study groupRoleWhat they receive
Simvastatin and standard treatmentExperimental40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis
Receives: Drug: Simvastatin 40mg
standard treatmentNo interventionconventional treatment of uveitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 weeks

Secondary outcomes (11)

  1. Visual acuity

    Assessment of visual acuity using the Golovin-Sivtsev table

    Measured: Baseline, 4 weeks, 8 weeks

  2. 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)

    Measured: Baseline, 4 weeks, 8 weeks

  3. 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)

    Measured: Baseline, 4 weeks, 8 weeks

  4. 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)

    Measured: Baseline, 4 weeks, 8 weeks

  5. Intraocular pressure

    Measured using Maklakov tonometer

    Measured: Baseline, 4 weeks, 8 weeks

  6. Changes in tear IL-6

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

    Measured: Baseline, 8 weeks

  7. Changes in tear IL-8

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

    Measured: Baseline, 8 weeks

  8. Changes in tear IL-10

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

    Measured: Baseline, 8 weeks

  9. Changes in tear TNFα

    Concentrations of TNFα (pg/ml) in tear samples

    Measured: Baseline, 8 weeks

  10. Changes in tear IFN-γ

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

    Measured: Baseline, 8 weeks

  11. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2019
  2. Study startSep 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04183387
Sponsor's protocol ID
SMV003
Status last verified
Nov 2019
First submitted
26 Nov 2019
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32377822

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simvastatin 40mg in people with Uveitis, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of corticosteroid sparing control of ocular inflammation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04183387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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