Condition category
Skin and Connective Tissue Diseases
Date applied
12/12/2006
Date assigned
29/01/2007
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr John K G Dart

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
+44 (0)20 7566 2036
j.dart@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 measures

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

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, Sjogren’s 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

http://www.moorfields.nhs.uk/Home

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes