The use of intraocular methotrexate to treat uveitis: a safety and efficacy study - Intraocular MTX for uveitis
Phase 1
- Conditions
- veitis (inflammatory eye disease)MedDRA version: 8.1 Level: LLT Classification code 10046851 Term: Uveitis
- Registration Number
- EUCTR2006-006728-20-GB
- Lead Sponsor
- Moorfields Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1) A diagnosis of uveitis with active disease in one eye only
2) History of intraocular pressure rise in response to corticosteroids
3) Sight-threatening manifestations, either vitritis or cystoid macular oedema
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) Bilateral active disease
2) Active ocular infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether intraocular methotrexate is a safe and effective treatment for uveitis in those who are considered unsuitable for intraocular corticosteroids.;Secondary Objective: ;Primary end point(s): Patients will be followed for 2 years post injection, monitoring visual acuity, inflammation, withdrawal of systemic medication and frequency of relapse.
- Secondary Outcome Measures
Name Time Method