ocular mucous membrane pemphigoid
Conditions
Interventions
Trade Name: Solu-Medrone
Pharmaceutical Form: Powder for infusion*
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Or
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed