Simvastatin in Uveitis

NCT ID: NCT04183387

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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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

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simvastatin and standard treatment

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

Group Type EXPERIMENTAL

Simvastatin 40mg

Intervention Type DRUG

standard treatment

conventional treatment of uveitis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simvastatin 40mg

Intervention Type DRUG

Other Intervention Names

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simvastatin

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Ivan Shirinsky, MD, PhD

Head of the Laboratory of Clinical Immunopharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laboratory of Clinical Immunopharmacology

Novosibirsk, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 32377822 (View on PubMed)

Other Identifiers

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SMV003

Identifier Type: -

Identifier Source: org_study_id

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