Trial Outcomes & Findings for LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye (NCT NCT03711929)
NCT ID: NCT03711929
Last Updated: 2023-12-04
Results Overview
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
Month 5
Results posted on
2023-12-04
Participant Flow
Unit of analysis: Study Eyes
Participant milestones
| Measure |
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution.
|
Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug).
|
|---|---|---|---|
|
Double Masked Treatment Period (DMTP)
STARTED
|
57 65
|
59 68
|
29 32
|
|
Double Masked Treatment Period (DMTP)
COMPLETED
|
51 59
|
48 55
|
24 27
|
|
Double Masked Treatment Period (DMTP)
NOT COMPLETED
|
6 6
|
11 13
|
5 5
|
|
Open Label Treatment Period (OLTP)
STARTED
|
42 49
|
40 47
|
21 24
|
|
Open Label Treatment Period (OLTP)
COMPLETED
|
34 40
|
35 41
|
15 16
|
|
Open Label Treatment Period (OLTP)
NOT COMPLETED
|
8 9
|
5 6
|
6 8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
Baseline characteristics by cohort
| Measure |
Test Arm: DE-109 Injectable Solution
n=57 Participants
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
|
Control Arm: Sham Procedure
n=59 Participants
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
Dummy Arm: DE-109 Injectable Solution
n=29 Participants
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm (which has the same route of administration and frequency as the test arm).
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 17.26 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 14.40 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 15.46 • n=4 Participants
|
|
Age, Customized
<65
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Age, Customized
>= 65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
14 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
India
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
11 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 5Population: Full Analysis Set
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
Outcome measures
| Measure |
Test Arm: DE-109 Injectable Solution
n=65 Study Eyes
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
|
Control Arm: Sham Procedure
n=68 Study Eyes
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
Dummy Arm: DE-109 Injectable Solution
n=32 Study Eyes
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
|
|---|---|---|---|
|
Vitreous Haze (VH) of Zero Response at Month 5
|
15.7 percentage response of study eyes
|
12.2 percentage response of study eyes
|
28.7 percentage response of study eyes
|
SECONDARY outcome
Timeframe: Month 3, Month 5Population: Full Analysis Set. The number of overall participants analyzed is consistent with data here and other parts of the record. Data represented in all records are for whole participants. Subjects with two study eyes had the composite score as the average score of both eyes.
Composite score scale is defined as follows. Each study eye was assigned one of the following scores: * Score = 3 if a study eye achieved Vitreous Haze (VH) score of 0 at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit. * Score = 2 if a study eye had at least improved (decreased) by 2 units (i.e., 2+ to 0, 3+ to 1+, or 4+ to 2+) in VH (compared to baseline) at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit. * Score = 1 if a study eye achieved VH score of 0.5+ at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit. * Score = -1 if a study eye got rescued due to worsening of uveitis or discontinued from the study due to lack of efficacy or due to adverse event prior to the specified visit. * Score = 0 if otherwise
Outcome measures
| Measure |
Test Arm: DE-109 Injectable Solution
n=57 Participants
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
|
Control Arm: Sham Procedure
n=59 Participants
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
Dummy Arm: DE-109 Injectable Solution
n=29 Participants
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
|
|---|---|---|---|
|
Mean Composite Score at Month 3 and Month 5
Month 3
|
0.4 score on a scale
Standard Deviation 1.10
|
0.3 score on a scale
Standard Deviation 0.80
|
0.4 score on a scale
Standard Deviation 0.98
|
|
Mean Composite Score at Month 3 and Month 5
Month 5
|
0.3 score on a scale
Standard Deviation 1.11
|
0.3 score on a scale
Standard Deviation 1.04
|
0.6 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Month 3Population: Full Analysis Set
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 3.
Outcome measures
| Measure |
Test Arm: DE-109 Injectable Solution
n=57 Participants
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
|
Control Arm: Sham Procedure
n=59 Participants
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
Dummy Arm: DE-109 Injectable Solution
n=32 Study Eyes
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
|
|---|---|---|---|
|
Vitreous Haze (VH) of Zero Response at Month 3
|
14.7 percentage response of study eyes
|
5.5 percentage response of study eyes
|
15.4 percentage response of study eyes
|
Adverse Events
DE-109 440 μg (Double Masked Treatment Period)
Serious events: 7 serious events
Other events: 47 other events
Deaths: 0 deaths
Sham Procedure (Double Masked Treatment Period)
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
DE-109 Fixed Dose (Double Masked Treatment Period)
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
DE-109 440 μg/DE-109 440 μg (Open Label Treatment Period)
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Sham/DE-109 440 μg (Open Label Treatment Period)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
DE-109 Fixed Dose/DE-109 440 μg (Open Label Treatment Period)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DE-109 440 μg (Double Masked Treatment Period)
n=57 participants at risk
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
|
Sham Procedure (Double Masked Treatment Period)
n=59 participants at risk
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
DE-109 Fixed Dose (Double Masked Treatment Period)
n=29 participants at risk
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm).
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
|
DE-109 440 μg/DE-109 440 μg (Open Label Treatment Period)
n=42 participants at risk
a 6-month open-label period in which all subjects continued to receive DE 109 440 μg every 2 months in the study eye.
|
Sham/DE-109 440 μg (Open Label Treatment Period)
n=40 participants at risk
a 6-month open-label period in which all subjects continued to receive DE 109 440 μg every 2 months in the study eye.
|
DE-109 Fixed Dose/DE-109 440 μg (Open Label Treatment Period)
n=21 participants at risk
a 6-month open-label period in which all subjects continued to receive DE 109 440 μg every 2 months in the study eye.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Injury, poisoning and procedural complications
Toxic anterior segment syndrome
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.5%
1/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Uveitis
|
3.5%
2/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Cataract
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.9%
2/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Angle closure glaucoma
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Birdshot chorioretinopathy
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Blindness
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Iridocyclitis
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Non-infectious endophthalmitis
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Infections and infestations
Endophthalmitis
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Infections and infestations
Eye abscess
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Nervous system disorders
Brain injury
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Nervous system disorders
Paraesthesia
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Nervous system disorders
Syncope
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
General disorders
Strangulated hernia
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
Other adverse events
| Measure |
DE-109 440 μg (Double Masked Treatment Period)
n=57 participants at risk
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
|
Sham Procedure (Double Masked Treatment Period)
n=59 participants at risk
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
|
DE-109 Fixed Dose (Double Masked Treatment Period)
n=29 participants at risk
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm).
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
|
DE-109 440 μg/DE-109 440 μg (Open Label Treatment Period)
n=42 participants at risk
a 6-month open-label period in which all subjects continued to receive DE 109 440 μg every 2 months in the study eye.
|
Sham/DE-109 440 μg (Open Label Treatment Period)
n=40 participants at risk
a 6-month open-label period in which all subjects continued to receive DE 109 440 μg every 2 months in the study eye.
|
DE-109 Fixed Dose/DE-109 440 μg (Open Label Treatment Period)
n=21 participants at risk
a 6-month open-label period in which all subjects continued to receive DE 109 440 μg every 2 months in the study eye.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Uveitis
|
15.8%
9/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
20.3%
12/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
17.2%
5/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
11.9%
5/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.0%
4/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
9.5%
2/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Cystoid macular oedema
|
10.5%
6/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
18.6%
11/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
7.1%
3/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.0%
4/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Conjunctival haemorrhage
|
12.3%
7/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
8.5%
5/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
13.8%
4/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
14.3%
6/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.0%
4/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
1/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Iridocyclitis
|
12.3%
7/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.8%
4/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.3%
3/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
2/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.0%
2/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
1/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Cataract
|
7.0%
4/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
13.8%
4/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
9.5%
4/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
7.5%
3/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Cataract subcapsular
|
5.3%
3/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.1%
3/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.3%
3/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
2/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.5%
1/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Eye pain
|
7.0%
4/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.0%
2/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
1/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Macular oedema
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.8%
4/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.5%
1/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Ocular hyperaemia
|
7.0%
4/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.5%
1/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.1%
3/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.0%
4/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
1/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Iris adhesions
|
3.5%
2/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.9%
2/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.0%
2/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Visual impairment
|
5.3%
3/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
7.1%
3/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Eye irritation
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.9%
2/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.5%
1/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Eye disorders
Keratic precipitates
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
2/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.9%
2/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.5%
1/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Investigations
Intraocular pressure increased
|
26.3%
15/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
13.6%
8/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
10.3%
3/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
21.4%
9/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
20.0%
8/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
1/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Investigations
Product residue present
|
7.0%
4/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
13.8%
4/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.0%
2/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
4.8%
1/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
6.9%
2/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Infections and infestations
Chorioretinitis
|
1.8%
1/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
8.5%
5/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
2.4%
1/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.0%
2/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
|
Nervous system disorders
Headache
|
5.3%
3/57 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
1.7%
1/59 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
3.4%
1/29 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/42 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
5.0%
2/40 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
0.00%
0/21 • Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER