Simvastatin in Uveitis
Open-label Randomized Study of Efficacy and Safety of Simvastatin in Uveitis
1 other identifier
interventional
50
1 country
1
Brief Summary
The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedDecember 3, 2019
November 1, 2019
1.3 years
November 26, 2019
November 28, 2019
Conditions
Outcome Measures
Primary Outcomes (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
8 weeks
Secondary Outcomes (11)
Visual acuity
Baseline, 4 weeks, 8 weeks
Anterior chamber cells
Baseline, 4 weeks, 8 weeks
Anterior chamber flare
Baseline, 4 weeks, 8 weeks
Vitreous haze
Baseline, 4 weeks, 8 weeks
Intraocular pressure
Baseline, 4 weeks, 8 weeks
- +6 more secondary outcomes
Study Arms (2)
Simvastatin and standard treatment
EXPERIMENTAL40 mg simvastatin per day for 2 months in addition to conventional treatment of uveitis
standard treatment
NO INTERVENTIONconventional treatment of uveitis
Interventions
Eligibility Criteria
You may qualify if:
- \- diagnosis of active non-infectious uveitis
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Clinical Immunopharmacology
Novosibirsk, 630047, Russia
Related Publications (1)
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.
PMID: 32377822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Laboratory of Clinical Immunopharmacology
Study Record Dates
First Submitted
November 26, 2019
First Posted
December 3, 2019
Study Start
September 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
December 3, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share