NCT02252328

Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients

Can Simvastatin Significantly Reduce the Amount of Immunosuppressive Medication Required by Patients With Sight Threatening Uveitis? A Phase 2b, Single Site, Randomized, Placebo Controlled, Double Blinded Trial.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 randomised in a 1:1 fashion to standard treatment with placebo or standard treatment with the addition of simvastatin (80mg daily). They will be followed at 3 months intervals for 2 years with a primary end point of mean reduction in corticosteroid dosage at the 12 month follow-up visit.

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 clinical effect the study is designed as a double blinded, parallel group, placebo-controlled, randomised trial. Double blinding will be achieved through the use of a placebo as well as a masked clinical assessor. Based on the reported effect of simvastatin on brain atrophy among multi\[le sclerosis patients after 12 months treatment, patients will receive treatment or placebo and will be treated and followed up for 24 months. Patients randomised to simvastatin will receive a dose of 80mg od. There will be no dose escalation. Patients will be reviewed every 3 months and will undergo a complete ophthalmic examination with treatment adjustment accordingly.

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	Simvastatin	Simvastatin 80mg once daily
DRUG	Placebo	Placebo tablets once daily

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-08-01
• Completion: 2019-08-01
• First posted: 2014-09-30
• Last updated: 2017-10-26

Locations

1 site across 1 country: United Kingdom