Contact information
Type
Scientific
Primary contact
Miss Valerie Saw
ORCID ID
Contact details
Imperial College NHS Trust & UCL Institute of Ophthalmology
London
EC1V 2PD
United Kingdom
+44 7875 483586
v.saw@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SAWV1003; RTF1226
Study information
Scientific title
A randomised trial of pulsed IntraVenous MethylPrednisolone for severe ocular pemphigoid
Acronym
IVMP
Study hypothesis
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
Medical Research Ethics Committee, 20/09/2005, ref: 05/Q1604/126
Study design
Randomised controlled single-masked clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Methylprednisolone
Primary outcome measure
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.
Secondary outcome measures
Proportion of patients achieving, at six weeks, a four-fold reduction in titre of circulating antibasement membrane antibodies.
Overall trial start date
20/01/2006
Overall trial end date
20/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant 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
Recruitment start date
20/01/2006
Recruitment end date
20/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Moorfields Eye Hospital NHS Foundation Trust (UK)
Sponsor details
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Special Trustees of Moorfields Eye Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University College London Graduate School Research Scholarship (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Action Medical Research (UK) (Ref: RTF1226)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list