Phase 4
N=255
Multicenter Uveitis Steroid Treatment (MUST) Trial
Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT00132691 ↗Enrolled (actual)
255
Serious AEs
47.8%
Results posted
Jul 2012
Primary outcome: Primary: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis — 6.0; 3.2 letters — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fluocinolone acetonide intraocular implant (Drug); oral corticosteroid with immunosuppressive agents as needed (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- JHSPH Center for Clinical Trials
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis |
6.0; 3.2 | 0.16 |
| SECONDARY Macular Edema |
22; 30 | 0.071 |
| SECONDARY Uveitis Activity |
12; 29 | 0.001 sig |
| SECONDARY Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg |
32.8; 6.3 | <.0001 sig |
| SECONDARY Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg |
53.1; 18.7 | <.0001 sig |
| SECONDARY Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline |
51.8; 15.5 | <.0001 sig |
| SECONDARY Glaucoma - Incident |
16.5; 4.0 | 0.0008 sig |
| SECONDARY Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up. |
61.1; 20.1 | <.0001 sig |
| SECONDARY Intraocular Pressure - IOP-lowering Surgery |
26.2; 3.7 | <0.0001 sig |
| SECONDARY Cataract - Incident Cataract |
90.7; 44.9 | <0.0001 sig |
| SECONDARY Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months |
11.44; 6.80 | 0.043 sig |
| SECONDARY Change in SF-36 Mental Component Score From Baseline to 24 Months |
2.55; -1.1 | 0.023 sig |
| SECONDARY Change in SF-36 Physical Component Score From Baseline to 24 Months |
1.15; -1.8 | 0.016 sig |
| SECONDARY Hyperlipidemia - Incident |
9.8; 11.0 | 0.84 |
| SECONDARY Hypertension Diagnosis Requiring Treatment |
4.6; 10.5 | 0.13 |
| SECONDARY Diabetes Mellitus |
1.0; 3.6 | 0.24 |
| SECONDARY Mortality |
1.6; 0 | — |
Summary
The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
Eligibility Criteria
Inclusion Criteria
- Age 13 years or older
- Best-corrected visual acuity of hand motions or better in at least one eye with uveitis
- Intraocular pressure 24 mm Hg or less in all eyes with uveitis
Exclusion Criteria
- Inadequately controlled diabetes
- Uncontrolled glaucoma
- Advanced glaucomatous optic nerve injury
- A history of scleritis; presence of an ocular toxoplasmosis scar.
- HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated according to best medical judgment
Data sourced from ClinicalTrials.gov (NCT00132691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.