Non-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
Conditions
Interventions
Trade Name: Retisert
Product Name: Retisert
Product Code: C05AA10
Pharmaceutical Form: Implant
INN or Proposed INN: FLUOCINOLONE ACETONI
Sponsors
National Institute of Health, National Eye Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: A) a local ocular treatment with an implant filled with a corticosteroid medicine called fluocinolone acetonide and B) systemic treatment with corticosteroid and if needed other immunosuppressive medicines taken by mouth. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not specified.;Timepoint(s) of evaluation of this end point: N/A. | — |
Countries
Australia, United Kingdom, United States
Contacts
Public ContactSue Lightman
National Institute of Health, National Eye Institute
Outcome results
None listed