Multicenter Uveitis Steroid Treatment Trial - MUST

Phase 1

• Conditions: on-infectious uveitis (inflammatory eye disease); MedDRA version: 9.1 Level: LLT Classification code 10046851 Term: Uveitis; MedDRA version: 9.1 Level: LLT Classification code 10033687 Term: Panuveitis; MedDRA version: 9.1 Level: LLT Classification code 10022557 Term: Intermediate uveitis; MedDRA version: 9.1 Level: LLT Classification code 10036370 Term: Posterior uveitis

• Registration Number: EUCTR2007-003612-53-GB
• Lead Sponsor: ational Institutes of Health, National Eye Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

- Age 18+
- Diagnosis of non-infectious intermediate uveitis, posterior uveitis or panuveitis
- Active uveitis of a degree for which systemic corticosteroid therapy is indicated
- Best-corrected visual acuity of hand motions or better
- Baseline intraocular pressure of 24 mm Hg or less

Note that the international protocol allows for enrollment of patients of 13+ years, but in the UK we have not and will not seek approval to recruit anyone under 18.
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

- Inadequately controlled diabetes mellitus
- Known allergy to study medication
- Uncontrolled glaucoma
- Advanced glaucomatous optic nerve injury
- A history of scleritis (concern of scleral melting)
- Pregnancy or breast-feeding
- HIV infection or other immundeficiency disease for which steroids would be contraindicated

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the visual outcomes of patients with uveitis treated with fluocinolone acetonide implant therapy to those treated with systemic therapy using oral corticosteroids.;<br> Secondary Objective: To compare the rates of local ocular corticosteroid-induced complications and the rates of systemic complications between treatment groups.<br><br> To compare the self-reported quality of life of the treatment groups.<br> ;Primary end point(s): Change in best-corrected visual acuity