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A randomised trial of pulsed intravenous methylprednisolone for severe ocular pemphigoid

A randomised trial of pulsed IntraVenous MethylPrednisolone for severe ocular pemphigoid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51714283
Enrollment
20
Registered
2007-01-29
Start date
2006-01-20
Completion date
Unknown
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular mucous membrane pemphigoid Skin and Connective Tissue Diseases Bullous disorders

Interventions

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 prednisol

Sponsors

Moorfields Eye Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Proportion of patients achieving, at six weeks, a four-fold reduction in titre of circulating antibasement membrane antibodies.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026