Uveitis Eye Diseases Disorders of globe
Conditions
Interventions
1. Oral tacrolimus (target trough serum level 8 - 12 ng/ml) only
2. Oral tacrolimus (target trough serum level 8 - 12 ng/ml) and oral prednisolone (7.5 - 10 mg daily)
Frequency of oral tacrolimus adm
Sponsors
United Bristol Healthcare Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in logarithm of the minimum angle of resolution (LogMAR) visual acuity (VA) between randomisation and study completion or withdrawal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of study withdrawal post-randomisation due to either treatment inefficacy (disease reactivation) or intolerance 2. Change in the following measures of disease severity between randomisation and study completion or withdrawal: 2.1. Binocular indirect ophthalmoscopy score 2.2. Anterior chamber cell grade 2.3. Retinal vasculitis score 2.4. Grade of optic disc swelling 2.5. Chorioretinal infiltrate 3. Change in the following assessments of treatment tolerance between randomisation and study completion or withdrawal: 3.1. Rate of onset of hypocholesterolemia, hypoglycaemia, hypertension, hypomagnesaemia and greater than or equal to 30% increase in serum creatinine concentration 3.2. Rate of onset of adverse events - overall by system (e.g. nervous system) and by description (e.g. tremor) 3.3. Rate of increase in intraocular pressure (IOP) to greater than 24 mmHg 4. Proportion of patients withdrawn post-enrolment and pre-randomisation for treatment inefficacy or intolerance 5. Change in quality of life in 3, 6 and 12 months after study enrolment, as assessed by the 36-item short form health survey (SF-36) and vision core module 1 (VCM1) scores | — |
Countries
United Kingdom
Outcome results
None listed