Dual steroid and tacrolimus therapy versus steroid withdrawal and tacrolimus therapy in the treatment of posterior segment intraocular inflammation (uveitis)

nited Bristol Healthcare Trust (UK)0 个研究点目标入组 40 人开始时间: 2008年4月16日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•Patients with sight-threatening non-infectious posterior intraocular inflammation (PSII) who:
•1. Are unable to reduce their prednisone dose to less than 10 mg daily without disease relapse
•2. Require recurrent high dose steroid rescue for recurrent relapsing disease
•3. Have severe sight-threatening disease warranting immediate institution of combination immunotherapy (high dose prednisone and a second line agent)
•4. Are greater than or equal to 18 years old, either sex, and able to give informed consent

•1. Pregnancy or lactation
•2. Female patients of child bearing age who are unwilling or unable to maintain effective birth control during the study
•3. Diabetes mellitus (except steroid induced)
•4. Significant and unstable renal disease (creatinine outside the local laboratories reference range on two consecutive occasions)
•5. Participating in another clinical trial or has been taking an investigational drug in the past 28 days
•6. Unlikely to comply with the visits scheduled in the protocol
•7. Live vaccinations within three months of study entry
•8. Previous adverse event associated with, or contra-indication to, either prednisolone or tacrolimus
•9. Concurrent use of other immunosuppressive or cytotoxic agents
•10. Previous tuberculosis
•11. Shingles within the past three months
•12. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), including current or previous history of opportunistic infections such as cytomegalovirus (CMV), active Pneumocystis carinii, atypical mycobacterium
•13. Recent history of substance abuse (drug or alcohol)
•14. Use of cyclosporin A within the last three months
•15. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous three months

发起方

nited Bristol Healthcare Trust (UK)