A randomised trial of pulsed intravenous methylprednisolone for severe ocular pemphigoid
| ISRCTN | ISRCTN51714283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51714283 |
| Protocol serial number | SAWV1003; RTF1226 |
| Sponsor | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Funders | Special Trustees of Moorfields Eye Hospital (UK), University College London Graduate School Research Scholarship (UK), Action Medical Research (UK) (Ref: RTF1226) |
- Submission date
- 12/12/2006
- Registration date
- 29/01/2007
- Last edited
- 15/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Valerie Saw
Scientific
Scientific
Imperial College NHS Trust & UCL Institute of Ophthalmology
London
EC1V 2PD
United Kingdom
| Phone | +44 7875 483586 |
|---|---|
| v.saw@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single-masked clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised trial of pulsed IntraVenous MethylPrednisolone for severe ocular pemphigoid |
| Study acronym | IVMP |
| Study objectives | To test the hypothesis that intravenous methylprednisolone induces more rapid control of ocular inflammation in patients with severe ocular pemphigoid (an intractable condition of the front surface of the eye which causes blindness by inflammation and irreversible scarring). |
| Ethics approval(s) | Medical Research Ethics Committee, 20/09/2005, ref: 05/Q1604/126 |
| Health condition(s) or problem(s) studied | Ocular mucous membrane pemphigoid |
| Intervention | Intervention: Intravenous methylprednisolone therapy 1 g in 250 ml of 0.9% saline daily administered over 30 minutes for three consecutive days, followed by a 6-233k tapering course of oral prednisolone 1 mg/kg/day, along with commencement of oral cyclophosphamide 1 - 2 mg/kg/day. Control treatment: Six and a half week course of oral prednisolone 1 mg/kg/day along with commencement of oral cyclophosphamide 1 - 2 mg/kg/day. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methylprednisolone |
| Primary outcome measure(s) |
Proportion of eyes achieving control of inflammation to grade 0 (nil) or grade 1 (minimal) at six weeks. This disease is not symmetric and responses between eyes can be very different. |
| Key secondary outcome measure(s) |
Proportion of patients achieving, at six weeks, a four-fold reduction in titre of circulating antibasement membrane antibodies. |
| Completion date | 20/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Patients with clinical features consistent with ocular mucous membrane pemphigoid 2. Patients with bilateral or unilateral moderate (grade 3) or severe (grade 4) ocular inflammation, with or without limbitis (i.e. oedema and increased vascularity along the limbus) 3. Patients may already be receiving non-cyclophosphamide immunosuppression |
| Key exclusion criteria | 1. Patients currently receiving cyclophosphamide 2. Patients with other causes of progressive conjunctival scarring (drug-induced pemphigoid with negative direct immunofluorescence biopsy, atopic keratoconjunctivitis, Sjogrens syndrome, Stevens Johnson syndrome, chemical injury) 3. Active secondary malignancy 4. HIuman immunodeficiency virus (HIV) infection 5. Pregnancy or breastfeeding |
| Date of first enrolment | 20/01/2006 |
| Date of final enrolment | 20/01/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Editorial Notes
15/06/2017: The study contact has changed from John K G Dart to Valerie Saw.
12/06/2017: No publications found in PubMed, verifying study status with principal investigator
