Status:
UNKNOWN
Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients
Lead Sponsor:
University College, London
Conditions:
Uveitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The trial will compare the effect on disease control and immunosuppression treatment of adding simvastatin 80mg once daily, over a follow-up and treatment period of 2 years. Patients will be randomise...
Detailed Description
This is a non-commercial trial to explore the effect of simvastatin 80mg od on the dose of corticosteroids and immunosuppression in patients with sight-threatening uveitis. In order to detect a clini...
Eligibility Criteria
Inclusion
- Patients must be \>18 years and under 80 years.
- Both sexes may participate, but, because of possible teratogenicity of simvastatin women may do so only following counselling about the need for adequate contraception.
- Women of child bearing potential will have to have a negative pregnancy test prior to enrolment.
- Patients must have been previously diagnosed with intermediate, posterior or panuveitis (as defined by the standardization of uveitis nomenclature group).14
- Patients must be taking systemic prednisolone 10mg once daily or more.
- Patients may be treated with or without a second line agent.
- Patients must be willing and able to provide informed consent
Exclusion
- No associated underlying systemic disease causing the uveitis.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment.
- Females must not be breastfeeding.
- Patients concomitantly taking ciclosporin, fibrates, amiodarone, amlodipine, verapamil, cytochrome P450 3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole), HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin, nefazodone, gemfibrozil, danazol, fusidic acid, diltiazem or anti-coagulants.
- Patients will be advised not to drink grapefruit juice during the study.
- Family history of hereditary muscle disorders.
- Active Liver disease
- Severe renal insufficiency.
- Persistently elevated serum transaminases.
- Allergies to excipients of simvastatin and placebo
- Lactose intolerance
- Involvement in other clinical trials
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02252328
Start Date
September 1 2015
End Date
August 1 2019
Last Update
October 26 2017
Active Locations (1)
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1
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD