ong term follow-up clinical trial to the MUST trial which investigates which treatment of systemic steroid treatment and a steroid implant which is inserted into the eye gives the best visual outcome for patients with chronic eye inflammation.

Phase 1

• Conditions: on-infectious pan, intermediate and posterior uveitis (inflammatory eye disease); MedDRA version: 14.0 Level: LLT Classification code 10033687 Term: Panuveitis System Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0 Level: PT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-001078-25-GB
• Lead Sponsor: ational Institute of Health, National Eye Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-21
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

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

Inclusion Criteria

Only patients that are currently enrolled in the Multicentre Uveitis Steroid Treatment (MUST) Trial (EudraCT number: 2007-003612-53, REC reference: 07/H0311/200) will be invited to participate in this trial. Therefore the inclusion criteria have not been stipulated for the this trial i.e. no naive patients will be enrolled. All the participants in the MUST trial are at least 18 years old.

The main inclusion criteria for the MUST trial are as follows:
1) Age 13 years or older ( we did not recruit patients less than 18 years old)
2) Diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis by a MUST-certified ophthalmologist
3) Active uveitis of a degree for which systemic corticosteroid therapy is indicated in the judgment of a MUST-certified ophthalmologist or such uveitis active within the last 60 days as determined either by examination by a MUST-certified ophthalmologist or by review of ophthalmic medical records by a MUST-certified ophthalmologist
4)Uveitis with or without an associated systemic disease is acceptable; however, the
systemic disease must not be sufficiently active that it dictates therapy with oral
corticosteroids or immunosuppressive agents at the time of study entry;
5) Best-corrected visual acuity (BCVA) of hand motions or better in at least one eye with uveitis
6) Baseline intraocular pressure 24 mm Hg or less in all eyes with uveitis
7) Collection of required baseline data within 10 days prior to randomization
8) Signed informed consent

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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Only patients that are currently enrolled in the Multicentre Uveitis Steroid Treatment (MUST) Trial (EudraCT number: 2007-003612-53, REC reference: 07/H0311/200) will be invited to participate in this trial. Therefore the exlusion criteria have not been stipulated for the this trial.

The main exclusion criteria for the MUST trial are as follows:

1) Diabetes mellitus that is inadequately controlled, according to best medical judgment
2) A known allergy to a required study medication
3) Uncontrolled glaucoma
4) Advanced glaucomatous optic nerve injury meeting the following criteria:
For patients able to perform a Humphrey Visual Field:
A) Depression of two or more points within 10 degrees of fixation by at least 10 dB
and/or
B) Mean deviation worse than -15 dB
For patients unable to perform a Humphrey Visual Field
A) Vertical C/D = 0.9
5) A history of scleritis (because of concerns regarding the potential for scleral melting
with local corticosteroid therapy)
6) Presence of an ocular toxoplasmosis scar
7) Pregnancy
8) Breastfeeding
9) Known human immunodeficiency virus infection or other immunodeficiency disease
for which corticosteroid therapy would be contraintraindicated according to best
medical judgment;
10) Patients for whom participation in the trial would constitute a risk exceeding the
potential benefits of study participation, in the judgment of the treating physician;
11) Medical problems or drug or alcohol dependence

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The main purpose of this trial is to compare how two different uveitis treatments control uveitis over a longer period of time. The two treatments are: <br> <br> A) a local ocular treatment with an implant filled with a corticosteroid medicine called fluocinolone acetonide and<br> B) systemic treatment with corticosteroid and if needed other immunosuppressive medicines taken by mouth. <br> ;Secondary Objective: This trial is also being conducted to get information about what happens to patients with different types of uveitis (inflammation of the eye) over time. This information may help researchers understand uveitis better and may suggest ways of improving treatment. These include looking at side-effects of treatments such as cataracts and glaucoma.;Primary end point(s): Change in best-corrected visual acuity. ;Timepoint(s) of evaluation of this end point: 6.5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not specified.;Timepoint(s) of evaluation of this end point: N/A.