Tacrolimus monotherapy for uveitis
| ISRCTN | ISRCTN46576063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46576063 |
| Secondary identifying numbers | OP/2004/1733 |
- Submission date
- 15/04/2008
- Registration date
- 16/04/2008
- Last edited
- 28/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Lee
Scientific
Scientific
Academic Unit of Ophthalmology
Bristol Eye Hospital
Lower Maudlin Street
Bristol
BS1 2LX
United Kingdom
| Phone | +44 (0)117 928 4949 |
|---|---|
| richard.lee@bristol.ac.uk |
Study information
| Study design | Dual-centre, randomised, non-inferiority, open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Dual steroid and tacrolimus therapy versus steroid withdrawal and tacrolimus therapy in the treatment of posterior segment intraocular inflammation (uveitis) |
| Study objectives | Tacrolimus monotherapy is not inferior to tacrolimus and prednisolone for the maintenance of uveitis remission. |
| Ethics approval(s) | Ethics approval received from North Somerset and South Bristol Research Ethics Committee on the 8th March 2004 (ref: E5862). |
| Health condition(s) or problem(s) studied | Uveitis |
| Intervention | 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 administration is the same for both trial arms. It is administered twice daily, however the oral dose prescribed to achieve the target serum levels varies from patient to patient. Treatment duration and follow-up are until study completion (i.e., nine months post randomisation), or withdrawal. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tacrolimus, prednisolone |
| Primary outcome measure | Change in logarithm of the minimum angle of resolution (LogMAR) visual acuity (VA) between randomisation and study completion or withdrawal. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/05/2004 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Ophthalmology
Bristol
BS1 2LX
United Kingdom
BS1 2LX
United Kingdom
Sponsor information
United Bristol Healthcare Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Effectiveness Department
UBHT Education Centre, Level 3
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
| Website | http://www.ubht.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Industry
Fujisawa Pharma Co Ltd (UK)
No information available
NHS R&D support funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
