Pulsed Intravenous Methylprednisolone for Ocular Pemphigoid- A Pilot Study - IVMP for ocular pemphigoid

Phase 1

• Conditions: ocular mucous membrane pemphigoid

• Registration Number: EUCTR2005-002391-14-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-23
• Study Completion: 2009-03-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Patients with clinical features consistent with ocular MMP i.e. progressive conjunctival cicatrisation and inflammation, with or without a positive result on direct immunofluorescence microscopy of a conjunctival, mucosal or skin biopsy showing linear basement membrane deposition of IgG, IgA, or C3, and/or a positive result on testing for anti-basement membrane zone antibodies.
2. All patients with bilateral or unilateral ‘severe’ (grade 4) ocular inflammation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. other causes of progressive conjunctival scarring (drug-induced pemphigoid with negative direct immunofluorescence biopsy, atopic keratoconjunctivitis, Sjogren’s syndrome, Stevens Johnson syndrome, chemical injury)
2. active secondary malignancy
3. HIV infection
4. pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the hypothesis that intravenous methylprednisolone induces more rapid control of ocular inflammation in patients with severe ocular pemphigoid who are commencing cyclophosphamide.;Secondary Objective: To investigate the hypothesis that intravenous methylprednisolone results in improved outcome in patients with severe ocular pemphigoid who are commencing cyclophosphamide.;Primary end point(s): The proportion of eyes achieving control of inflammation to grade 0 (nil) or grade 1 (minimal) at 2 months.