Multicenter Uveitis Steroid Treatment Trial - MUST

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003612-53-GB

Enrollment

250

Registered

2008-01-18

Start date

2008-07-25

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Non-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

Interventions

Trade Name: Retisert Product Name: Retisert Pharmaceutical Form: Injection* INN or Proposed INN: FLUOCINOLONE ACETONIDE CAS Number: 6773

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: To compare the rates of local ocular corticosteroid-induced complications and the rates of systemic complications between treatment groups. To compare the self-reported quality of life of the treatment groups. ;Primary end point(s): Change in best-corrected visual acuity	—

Measure

Time frame

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.; Secondary Objective: To compare the rates of local ocular corticosteroid-induced complications and the rates of systemic complications between treatment groups. To compare the self-reported quality of life of the treatment groups. ;Primary end point(s): Change in best-corrected visual acuity

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Countries

United Kingdom

Outcome results

None listed

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