A randomised trial of pulsed intravenous methylprednisolone for severe ocular pemphigoid

ISRCTN	ISRCTN51714283
DOI	https://doi.org/10.1186/ISRCTN51714283
Secondary identifying numbers	SAWV1003; 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

Imperial College NHS Trust & UCL Institute of Ophthalmology
London
EC1V 2PD
United Kingdom

Phone	+44 7875 483586
Email	v.saw@ucl.ac.uk

Study information

Study design	Randomised controlled single-masked clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	20/01/2006
Completion date	20/01/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Moorfields Eye Hospital

London
EC1V 2PD
United Kingdom

Sponsor information

Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

162 City Road
London
EC1V 2PD
England
United Kingdom

Website	http://www.moorfields.nhs.uk/Home
"ROR"	https://ror.org/03zaddr67

Funders

Funder type

Hospital/treatment centre

Special Trustees of Moorfields Eye Hospital (UK)

No information available

University College London Graduate School Research Scholarship (UK)

No information available

Action Medical Research (UK) (Ref: RTF1226)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

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

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