Trial Outcomes & Findings for Multicenter Uveitis Steroid Treatment (MUST) Trial (NCT NCT00132691)
NCT ID: NCT00132691
Last Updated: 2016-11-25
Results Overview
Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.
COMPLETED
PHASE4
255 participants
24 months
2016-11-25
Participant Flow
Eligible patients were enrolled at 23 uveitis centers in the US, the United Kingdom and Australia from 6 December 2005 to 9 December 2008.
579 patients were assessed for initial eligibility (e.g. through chart review). Patients who were potentially eligible and interested in joining the trial signed an informed consent and underwent a baseline visit to confirm eligibility. Eligible patients (255) were randomly assigned to systemic treatment or implant treatment.
Participant milestones
| Measure |
Flucinolone Acetonide Intraocular Implant
Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch \& Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
|
Standard Systemic Treatment
Systemic corticosteroid therapy with immunosuppression as indicated
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
126
|
|
Overall Study
COMPLETED
|
118
|
114
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Flucinolone Acetonide Intraocular Implant
Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch \& Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
|
Standard Systemic Treatment
Systemic corticosteroid therapy with immunosuppression as indicated
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
Missed 2-year visit
|
4
|
4
|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
Multicenter Uveitis Steroid Treatment (MUST) Trial
Baseline characteristics by cohort
| Measure |
Flucinolone Acetonide Intraocular Implant
n=129 Participants
Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch \& Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
|
Standard Systemic Treatment
n=126 Participants
Systemic corticosteroid therapy with immunosuppression as indicated
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 15 • n=5 Participants
|
47 years
STANDARD_DEVIATION 15 • n=7 Participants
|
46 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
72 participants
n=5 Participants
|
70 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 participants
n=5 Participants
|
31 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
104 participants
n=7 Participants
|
213 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Bilateral uveitis
|
116 participants
n=5 Participants
|
108 participants
n=7 Participants
|
224 participants
n=5 Participants
|
|
Site of uveitis
Intermediate
|
50 participants
n=5 Participants
|
47 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Site of uveitis
Posterior or Panuveitis
|
79 participants
n=5 Participants
|
79 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Associated systemic inflammatory disease
Yes
|
36 participants
n=5 Participants
|
33 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Associated systemic inflammatory disease
no
|
93 participants
n=5 Participants
|
93 participants
n=7 Participants
|
186 participants
n=5 Participants
|
|
Visual acuity 20/40 or better
|
116 eyes
n=5 Participants
|
122 eyes
n=7 Participants
|
238 eyes
n=5 Participants
|
|
Active uveitis
|
192 eyes
n=5 Participants
|
181 eyes
n=7 Participants
|
373 eyes
n=5 Participants
|
|
Visual acuity 20/200 or worse
|
39 eyes
n=5 Participants
|
35 eyes
n=7 Participants
|
74 eyes
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The primary analysis was an intention-to-treat analysis; analysis was conducted "as randomized". Data from the 255 randomized participants were used in the analytic model. 232 of the 255 completed the 2 year outcome visit.
Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=129 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=126 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
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 letters
Standard Error 1.4
|
3.2 letters
Standard Error 1.4
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy)..
center point macular thickness \>= 240 micrometers assessed on OCT (Stratus OCT-3 \[Carl Zeiss Meditec, Dublin, CA\]) as graded by Central Reading Center
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=245 eyes with macular edema
Participants randomized to receive implant therapy
|
Systemic Therapy
n=234 eyes with macular edema
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Macular Edema
|
22 percentage of eyes with uveitis
Interval 14.0 to 30.0
|
30 percentage of eyes with uveitis
Interval 21.0 to 40.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy).
Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=245 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=234 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Uveitis Activity
|
12 percentage of eyes with uveitis
Interval 6.0 to 20.0
|
29 percentage of eyes with uveitis
Interval 21.0 to 39.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=234 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=229 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg
|
32.8 percentage of eyes with uveitis at risk
Interval 27.1 to 39.2
|
6.3 percentage of eyes with uveitis at risk
Interval 3.7 to 10.3
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=234 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=228 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg
|
53.1 percentage of eyes with uveitis at risk
Interval 46.9 to 59.7
|
18.7 percentage of eyes with uveitis at risk
Interval 14.2 to 24.5
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=235 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=230 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline
|
51.8 percentage of eyes with uveitis at risk
Interval 45.5 to 58.3
|
15.5 percentage of eyes with uveitis at risk
Interval 11.4 to 20.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=212 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=202 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Glaucoma - Incident
|
16.5 percentage of eyes with uveitis at risk
Interval 12.1 to 22.2
|
4.0 percentage of eyes with uveitis at risk
Interval 2.0 to 7.8
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=201 eyes
Participants randomized to receive implant therapy
|
Systemic Therapy
n=203 eyes
Participants randomized to receive systemic therapy
|
|---|---|---|
|
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 percentage of eyes with uveitis at risk
Interval 54.3 to 67.8
|
20.1 percentage of eyes with uveitis at risk
Interval 15.1 to 26.3
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=233 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=226 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Intraocular Pressure - IOP-lowering Surgery
|
26.2 percentage of eyes with uveitis at risk
Interval 21.0 to 32.4
|
3.7 percentage of eyes with uveitis at risk
Interval 1.9 to 7.2
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=54 eyes with uveitis
Participants randomized to receive implant therapy
|
Systemic Therapy
n=50 eyes with uveitis
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Cataract - Incident Cataract
|
90.7 percentage of eyes with uveitis at risk
Interval 81.3 to 96.6
|
44.9 percentage of eyes with uveitis at risk
Interval 32.3 to 59.8
|
SECONDARY outcome
Timeframe: 24 monthsThe NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=129 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=126 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
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 units on a scale (composite score)
Standard Error 1.67
|
6.80 units on a scale (composite score)
Standard Error 1.58
|
SECONDARY outcome
Timeframe: 24 monthsSelf-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=129 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=126 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Change in SF-36 Mental Component Score From Baseline to 24 Months
|
2.55 units on a scale
Standard Error 1.11
|
-1.1 units on a scale
Standard Error 1.15
|
SECONDARY outcome
Timeframe: 24 monthsSelf-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=129 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=126 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Change in SF-36 Physical Component Score From Baseline to 24 Months
|
1.15 units on a scale
Standard Error 0.83
|
-1.8 units on a scale
Standard Error 0.90
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Number of participants at risk were included in the analysis
LDL greater than or equal to 160 mg/mL
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=97 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=104 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Hyperlipidemia - Incident
|
9.8 percentage of participants at risk
Interval 5.2 to 18.0
|
11.0 percentage of participants at risk
Interval 6.3 to 19.1
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Participants with prevalent complications or missing data at enrollment were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=88 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=88 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Hypertension Diagnosis Requiring Treatment
|
4.6 percentage of participants
Interval 1.8 to 11.9
|
10.5 percentage of participants
Interval 5.6 to 19.3
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Participants with prevalent complications or missing data at enrollment were excluded from the risk set.
Outcome measures
| Measure |
Fluocinolone Acetonide Implant
n=105 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=114 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Diabetes Mellitus
|
1.0 percentage of participants
Interval 0.1 to 6.6
|
3.6 percentage of participants
Interval 1.4 to 9.4
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Fluocinolone Acetonide Implant
n=126 Participants
Participants randomized to receive implant therapy
|
Systemic Therapy
n=124 Participants
Participants randomized to receive systemic therapy
|
|---|---|---|
|
Mortality
|
1.6 percentage of participants
Interval 0.4 to 6.3
|
0 percentage of participants
no deaths reported in systemic group
|
Adverse Events
Flucinolone Acetonide Implant
Systemic Therapy
Serious adverse events
| Measure |
Flucinolone Acetonide Implant
n=129 participants at risk
Participants randomized to receive implant therapy.
|
Systemic Therapy
n=126 participants at risk
Participants randomized to receive systemic therapy.
|
|---|---|---|
|
Eye disorders
Endophthalmitis
|
2.3%
3/129 • Number of events 3 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Glaucoma
|
5.4%
7/129 • Number of events 11 • 2 years
|
0.79%
1/126 • Number of events 2 • 2 years
|
|
Eye disorders
Hypotony
|
3.1%
4/129 • Number of events 4 • 2 years
|
1.6%
2/126 • Number of events 2 • 2 years
|
|
Eye disorders
Ocular Hypertension
|
24.8%
32/129 • Number of events 54 • 2 years
|
4.0%
5/126 • Number of events 6 • 2 years
|
|
Eye disorders
Retinal Detachment
|
3.1%
4/129 • Number of events 5 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Eye disorders
Vitreous Hemorrhage
|
10.9%
14/129 • Number of events 15 • 2 years
|
3.2%
4/126 • Number of events 5 • 2 years
|
|
Eye disorders
Bleb revision
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Complication of Kenalog injection
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Enucleation
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Eye disorders
Hospitalization for cataract surgery
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 2 • 2 years
|
|
Eye disorders
Retisert wound dehiscence
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Choroidal neovascularization
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Hyphema
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Exposed suture
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Surgery to reposition shunt
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Iris bombe
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Exposed Ahmed valve
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Orbital cellulitis
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Revision of Ahmed valve
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Eye disorders
Abnormal ERG
|
0.00%
0/120 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Hospitalization for observation while on prednisone
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Nervous system disorders
Anterior cervical dissection, fusion
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Gastrointestinal disorders
Diarrhea, dehydration
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Ileostomy takedown
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Perforated viscus lung cancer
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Cardiac disorders
Pericardial drain placement
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Kidney stones
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Hip replacement
|
1.6%
2/129 • Number of events 2 • 2 years
|
0.00%
0/126 • 2 years
|
|
Reproductive system and breast disorders
Precancerous cells right breast
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
General disorders
Prolonged hospitalization stay due to reaction
|
0.83%
1/120 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Shoulder surgery
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Endocrine disorders
Total thyroidectomy
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
General disorders
Abdominal pain
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthrosis due to aseptic necrosis
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Dislocation of hip
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Exacerbation of intestinal fissure
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
General disorders
Flu-like reaction to Avonex
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Gall bladder surgery
|
0.00%
0/129 • 2 years
|
1.6%
2/126 • Number of events 2 • 2 years
|
|
Cardiac disorders
Hypertension
|
5.4%
7/129 • Number of events 12 • 2 years
|
2.4%
3/126 • Number of events 5 • 2 years
|
|
Renal and urinary disorders
Hemmorhagic cystitis
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
General disorders
Hospitalization
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization for post-surgical observation of pharyngeal papilloma biopsy
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Torn medial meniscus
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Immune system disorders
Neuro Bechet's disease
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.78%
1/129 • Number of events 1 • 2 years
|
0.00%
0/126 • 2 years
|
|
Psychiatric disorders
Psychotic episode
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Abnormal laboratory value
|
3.1%
4/129 • Number of events 5 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.78%
1/129 • Number of events 1 • 2 years
|
2.4%
3/126 • Number of events 3 • 2 years
|
|
Infections and infestations
Infection
|
4.7%
6/129 • Number of events 9 • 2 years
|
4.0%
5/126 • Number of events 5 • 2 years
|
|
Reproductive system and breast disorders
Miscarriage
|
0.78%
1/129 • Number of events 1 • 2 years
|
2.4%
3/126 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Non-melanoma skin cancer
|
0.78%
1/129 • Number of events 1 • 2 years
|
2.4%
3/126 • Number of events 7 • 2 years
|
|
Cardiac disorders
Cardiovascular
|
1.6%
2/129 • Number of events 2 • 2 years
|
3.2%
4/126 • Number of events 5 • 2 years
|
|
Vascular disorders
Thrombosis
|
3.1%
4/129 • Number of events 4 • 2 years
|
1.6%
2/126 • Number of events 2 • 2 years
|
|
General disorders
Headache due to hypertension
|
0.00%
0/129 • 2 years
|
0.79%
1/126 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.78%
1/129 • Number of events 1 • 2 years
|
4.8%
6/126 • Number of events 6 • 2 years
|
|
Investigations
Chest pain
|
0.78%
1/129 • Number of events 2 • 2 years
|
2.4%
3/126 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.78%
1/129 • Number of events 3 • 2 years
|
1.6%
2/126 • Number of events 2 • 2 years
|
Other adverse events
| Measure |
Flucinolone Acetonide Implant
n=129 participants at risk
Participants randomized to receive implant therapy.
|
Systemic Therapy
n=126 participants at risk
Participants randomized to receive systemic therapy.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia (fasting)
|
3.1%
4/129 • Number of events 4 • 2 years
|
7.9%
10/126 • Number of events 16 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia (casual)
|
4.7%
6/129 • Number of events 8 • 2 years
|
7.9%
10/126 • Number of events 16 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.4%
7/129 • Number of events 8 • 2 years
|
4.8%
6/126 • Number of events 6 • 2 years
|
|
Metabolism and nutrition disorders
Triglyceride (high)
|
7.8%
10/129 • Number of events 12 • 2 years
|
7.9%
10/126 • Number of events 12 • 2 years
|
|
Hepatobiliary disorders
SGOT (AST) or SGPT (ALT)
|
3.9%
5/129 • Number of events 9 • 2 years
|
6.3%
8/126 • Number of events 13 • 2 years
|
|
Renal and urinary disorders
BUN
|
6.2%
8/129 • Number of events 8 • 2 years
|
7.9%
10/126 • Number of events 16 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
3.9%
5/129 • Number of events 7 • 2 years
|
15.9%
20/126 • Number of events 24 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
5/129 • Number of events 5 • 2 years
|
8.7%
11/126 • Number of events 15 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
2/129 • Number of events 2 • 2 years
|
9.5%
12/126 • Number of events 16 • 2 years
|
|
Psychiatric disorders
Mood
|
3.1%
4/129 • Number of events 4 • 2 years
|
8.7%
11/126 • Number of events 12 • 2 years
|
|
General disorders
Headache
|
19.4%
25/129 • Number of events 36 • 2 years
|
15.1%
19/126 • Number of events 21 • 2 years
|
|
General disorders
Fatigue
|
4.7%
6/129 • Number of events 7 • 2 years
|
8.7%
11/126 • Number of events 15 • 2 years
|
|
Cardiac disorders
Hypertension (systolic)
|
20.9%
27/129 • Number of events 38 • 2 years
|
25.4%
32/126 • Number of events 62 • 2 years
|
|
Cardiac disorders
Hypertension (diastolic)
|
18.6%
24/129 • Number of events 39 • 2 years
|
23.8%
30/126 • Number of events 47 • 2 years
|
|
Immune system disorders
Allergic reaction
|
7.8%
10/129 • Number of events 16 • 2 years
|
7.1%
9/126 • Number of events 11 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
9.3%
12/129 • Number of events 12 • 2 years
|
7.9%
10/126 • Number of events 10 • 2 years
|
|
General disorders
Infection
|
40.3%
52/129 • Number of events 116 • 2 years
|
53.2%
67/126 • Number of events 178 • 2 years
|
|
Eye disorders
Ocular hypertension
|
60.5%
78/129 • Number of events 246 • 2 years
|
23.0%
29/126 • Number of events 67 • 2 years
|
|
Eye disorders
Glaucoma
|
7.8%
10/129 • Number of events 13 • 2 years
|
1.6%
2/126 • Number of events 5 • 2 years
|
|
Eye disorders
Hypotony
|
20.2%
26/129 • Number of events 46 • 2 years
|
7.9%
10/126 • Number of events 28 • 2 years
|
|
Eye disorders
Cataract
|
31.0%
40/129 • Number of events 65 • 2 years
|
10.3%
13/126 • Number of events 15 • 2 years
|
|
Eye disorders
Vitreous hemorrhage
|
10.1%
13/129 • Number of events 15 • 2 years
|
1.6%
2/126 • Number of events 2 • 2 years
|
Additional Information
John H. Kempen, MD, PhD, MUST Trial Vice-Chairman
Center for Presventive Ophthalmology and Biostatistics, Department of Ophthalmology, University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place