Tacrolimus monotherapy for uveitis

Completed

• Conditions: veitis; Eye Diseases; Disorders of globe

• Registration Number: ISRCTN46576063
• Lead Sponsor: nited Bristol Healthcare Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in logarithm of the minimum angle of resolution (LogMAR) visual acuity (VA) between randomisation and study completion or withdrawal.