Trial Outcomes & Findings for Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert (NCT NCT05070728)
NCT ID: NCT05070728
Last Updated: 2024-12-19
Results Overview
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
Week 24
Results posted on
2024-12-19
Participant Flow
This Phase 3 prospective, controlled study was conducted in subjects with chronic non-infectious uveitis affecting the posterior segment of the eye at 8 sites in the United States between 13 October 2021 and 12 April 2023.
This study consists of a screening period (up to 30 days) and treatment period (52 weeks). A total of 12 subjects were enrolled in the study.
Unit of analysis: Eyes
Participant milestones
| Measure |
Fluocinolone Acetonide 0.05 mg
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
6 12
|
6 12
|
|
Overall Study
COMPLETED
|
6 12
|
0 0
|
|
Overall Study
NOT COMPLETED
|
0 0
|
6 12
|
Reasons for withdrawal
| Measure |
Fluocinolone Acetonide 0.05 mg
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Overall Study
Sponsor decided to stop study enrollment and terminate the study
|
0
|
6
|
Baseline Characteristics
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert
Baseline characteristics by cohort
| Measure |
Fluocinolone Acetonide 0.05 mg
n=6 Participants
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
n=6 Participants
Subjects received a single intravitreal sham injection on Day 1.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 19.23 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 15.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.
Outcome measures
| Measure |
Fluocinolone Acetonide 0.05 mg
n=6 Participants
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
|
0 percentage of subjects
Interval 0.0 to 45.9
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Outcome measures
| Measure |
Fluocinolone Acetonide 0.05 mg
n=6 Participants
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52
|
0 percentage of subjects
Interval 0.0 to 45.9
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: Data was not collected for this outcome measure due to early termination of study.
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure.
Outcome measures
| Measure |
Fluocinolone Acetonide 0.05 mg
n=6 Participants
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52
Week 24
|
9.7 score on a scale
Standard Deviation 4.93
|
—
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52
Weeks 52
|
16.8 score on a scale
Standard Deviation 12.11
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
Recurrence was defined as: An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Outcome measures
| Measure |
Fluocinolone Acetonide 0.05 mg
n=6 Participants
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Number of Recurrences of Uveitis Within 24 and 52 Weeks
Week 24
|
0 recurrences of uveitis
|
—
|
|
Number of Recurrences of Uveitis Within 24 and 52 Weeks
Week 52
|
0 recurrences of uveitis
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: The ITT analysis set included all subjects who were randomized. Only subjects with recurrence of uveitis are reported. Data was not collected for Sham injection group due to early termination of study.
Recurrence was defined as: An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: The ITT analysis set included all subjects who were randomized. Only subjects with recurrence of uveitis are reported. Data was not collected for Sham injection group due to early termination of study.
Recurrence was defined as: An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit). In the event of a uveitis recurrence in either eye, peri-ocular or intraocular corticosteroid injections, or topical medications administered as first line local therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 24 and 52Population: Data was not collected for this outcome measure due to early termination of study.
Iridocyclitis was defined as a \>2-step increase in anterior chamber cells per high-power field (HPF) (1.6\*using a 1-millimeter beam).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 28 and Months 2, 3, 6 and 12Population: The ITT analysis set included all subjects who were randomized. Only subjects analyzed at specific timepoints are reported.
The macular edema was measured by spectral-domain - optical coherence tomography (SD-OCT) imaging.
Outcome measures
| Measure |
Fluocinolone Acetonide 0.05 mg
n=6 Participants
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1.
|
Sham Injection
n=6 Participants
Subjects received a single intravitreal sham injection on Day 1.
|
|---|---|---|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Day 28 - Yes
|
50.0 percentage of subjects
|
60.0 percentage of subjects
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Day 28 - No
|
50.0 percentage of subjects
|
40.0 percentage of subjects
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 2 - Yes
|
50.0 percentage of subjects
|
75.0 percentage of subjects
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 2 - No
|
50.0 percentage of subjects
|
25.0 percentage of subjects
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 3 - Yes
|
40.0 percentage of subjects
|
33.3 percentage of subjects
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 3 - No
|
60.0 percentage of subjects
|
66.7 percentage of subjects
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 6 - Yes
|
20.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 6 - No
|
80.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 12 - Yes
|
75.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Month 12 - No
|
25.0 percentage of subjects
|
—
|
Adverse Events
Fluocinolone Acetonide 0.05 mg - Study Eye
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fluocinolone Acetonide 0.05 mg - Fellow Eye
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fluocinolone Acetonide 0.05 mg - Systemic
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Injection- Study Eye
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham Injection- Fellow Eye
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Injection- Systemic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluocinolone Acetonide 0.05 mg - Study Eye
n=6 participants at risk
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg in study eye on Day 1.
|
Fluocinolone Acetonide 0.05 mg - Fellow Eye
n=6 participants at risk
No study treatment administered in fellow eye.
|
Fluocinolone Acetonide 0.05 mg - Systemic
n=6 participants at risk
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg in study eye on Day 1.
|
Sham Injection- Study Eye
n=6 participants at risk
Subjects received a single intravitreal sham injection in study eye on Day 1.
|
Sham Injection- Fellow Eye
n=6 participants at risk
No sham treatment administered in fellow eye.
|
Sham Injection- Systemic
n=6 participants at risk
Subjects received a single intravitreal sham injection in study eye on Day 1.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
Other adverse events
| Measure |
Fluocinolone Acetonide 0.05 mg - Study Eye
n=6 participants at risk
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg in study eye on Day 1.
|
Fluocinolone Acetonide 0.05 mg - Fellow Eye
n=6 participants at risk
No study treatment administered in fellow eye.
|
Fluocinolone Acetonide 0.05 mg - Systemic
n=6 participants at risk
Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg in study eye on Day 1.
|
Sham Injection- Study Eye
n=6 participants at risk
Subjects received a single intravitreal sham injection in study eye on Day 1.
|
Sham Injection- Fellow Eye
n=6 participants at risk
No sham treatment administered in fellow eye.
|
Sham Injection- Systemic
n=6 participants at risk
Subjects received a single intravitreal sham injection in study eye on Day 1.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Epiretinal membrane
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Optic atrophy
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Posterior capsule opacification
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Vitreal cells
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Vitreous haze
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Investigations
Intraocular pressure increased
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
16.7%
1/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.
The Safety Analysis Set included all subjects who were randomized and received fluocinolone acetonide 0.05 mg or sham injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place