Trial Outcomes & Findings for Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD) (NCT NCT01397409)
NCT ID: NCT01397409
Last Updated: 2019-04-16
Results Overview
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
271 participants
Primary outcome timeframe
24 Weeks
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
|
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
9
|
6
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
9
|
6
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
67
|
58
|
58
|
0
|
0
|
0
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
59
|
54
|
58
|
0
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
8
|
4
|
0
|
0
|
0
|
0
|
|
Stage 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
25
|
16
|
|
Stage 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
25
|
16
|
|
Stage 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
|
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
6
|
3
|
0
|
0
|
0
|
0
|
|
Stage 2
Personal Reasons
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Other Miscellaneous Reasons
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Stage 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 3
Other Miscellaneous Reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Stage 1: AGN-150998 4.2 mg
n=9 Participants
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 3.0 mg
n=6 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 2.0 mg
n=6 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 1.0 mg
n=3 Participants
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
|
Stage 2: AGN-150998 4.2 mg
n=67 Participants
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: AGN-150998 3.0 mg
n=58 Participants
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: Ranibizumab 0.5 mg
n=58 Participants
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 3: AGN-150998 2.0 mg
n=23 Participants
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: AGN-150998 1.0 mg
n=25 Participants
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: Ranibizumab 0.5 mg
n=16 Participants
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
82.3 Years
n=5 Participants
|
75.3 Years
n=7 Participants
|
79.3 Years
n=5 Participants
|
67.7 Years
n=4 Participants
|
80.4 Years
n=21 Participants
|
78.6 Years
n=10 Participants
|
78.5 Years
n=115 Participants
|
77.9 Years
n=6 Participants
|
75.5 Years
n=6 Participants
|
76.5 Years
n=64 Participants
|
77.2 Years
n=17 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
159 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
112 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Safety population included all treated participants.
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Outcome measures
| Measure |
Stage 1 All Participants
n=24 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Highest Tolerated Dose (HTD) of AGN-150998
|
4.2 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Safety population included all treated participants.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Stage 1 All Participants
n=9 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=6 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=6 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
n=3 Participants
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Baseline
|
527.6 microns
Standard Deviation 126.79
|
540.3 microns
Standard Deviation 284.34
|
500.3 microns
Standard Deviation 155.65
|
564.3 microns
Standard Deviation 115.68
|
|
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 4 (n=9,6,6,2)
|
-185.4 microns
Standard Deviation 161.23
|
-239.5 microns
Standard Deviation 234.03
|
-212.3 microns
Standard Deviation 182.94
|
-113.5 microns
Standard Deviation 135.06
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Per-protocol Population included all treated participants who received all scheduled treatments.
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
Outcome measures
| Measure |
Stage 1 All Participants
n=65 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=57 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=57 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
|
59.0 days
Interval 43.0 to 109.0
|
57.0 days
Interval 43.0 to 86.0
|
57.0 days
Interval 43.0 to 85.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Modified-Intent-to-Treat (mITT) Population
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Stage 1 All Participants
n=23 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=25 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=16 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
58.5 letters
Standard Deviation 14.29
|
58.4 letters
Standard Deviation 13.49
|
60.4 letters
Standard Deviation 16.41
|
—
|
|
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at Week 16
|
8.2 letters
Standard Deviation 7.89
|
6.3 letters
Standard Deviation 7.81
|
5.3 letters
Standard Deviation 11.08
|
—
|
SECONDARY outcome
Timeframe: 32 WeeksPopulation: mITT Population
Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.
Outcome measures
| Measure |
Stage 1 All Participants
n=62 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=55 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=58 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 2: Time Between Second Treatment and Recurrence of Active Disease
|
85.0 days
Interval 57.0 to 118.0
|
112.0 days
Interval 60.0 to
75% Upper Limit not estimated.
|
111.0 days
Interval 57.0 to
75% Upper Limit not estimated.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Per-protocol Population included all treated participants who received all scheduled treatments.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Stage 1 All Participants
n=65 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=57 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=57 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Baseline
|
524.6 microns
Standard Deviation 170.71
|
507.3 microns
Standard Deviation 139.88
|
497.1 microns
Standard Deviation 122.04
|
—
|
|
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 4 (n=61,56,57)
|
-179.5 microns
Standard Deviation 123.76
|
-155.3 microns
Standard Deviation 109.13
|
-157.3 microns
Standard Deviation 121.95
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Per-protocol Population included all treated participants who received all scheduled treatments.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Stage 1 All Participants
n=65 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=57 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=57 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
54.5 letters
Standard Deviation 13.90
|
52.7 letters
Standard Deviation 12.62
|
55.4 letters
Standard Deviation 13.00
|
—
|
|
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at Week 4 (n=62,56,57)
|
4.7 letters
Standard Deviation 9.71
|
8.4 letters
Standard Deviation 11.51
|
5.9 letters
Standard Deviation 64.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Per-protocol Population included all treated participants who received all scheduled treatments.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Stage 1 All Participants
n=23 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=25 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=16 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Baseline
|
466.0 microns
Standard Deviation 125.96
|
526.1 microns
Standard Deviation 165.09
|
463.3 microns
Standard Deviation 94.56
|
—
|
|
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 4
|
-119.8 microns
Standard Deviation 68.50
|
-168.3 microns
Standard Deviation 137.07
|
-98.4 microns
Standard Deviation 65.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Per-protocol Population included all treated participants who received all scheduled treatments.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Stage 1 All Participants
n=23 Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
|
Stage 1: AGN-150998 3.0 mg
n=25 Participants
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 2.0 mg
n=16 Participants
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
|
|---|---|---|---|---|
|
Stage 3: Change From Baseline in BCVA in the Study Eye
Baseline
|
58.5 letters
Standard Deviation 14.29
|
58.4 letters
Standard Deviation 13.49
|
60.4 letters
Standard Deviation 16.41
|
—
|
|
Stage 3: Change From Baseline in BCVA in the Study Eye
Change from Baseline at Week 4
|
5.0 letters
Standard Deviation 7.40
|
4.6 letters
Standard Deviation 5.98
|
3.9 letters
Standard Deviation 6.01
|
—
|
Adverse Events
Stage 1: AGN-150998 4.2 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1: AGN-150998 3.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 1: AGN-150998 2.0 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1: AGN-150998 1.0 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 2: AGN-150998 4.2 mg
Serious events: 11 serious events
Other events: 51 other events
Deaths: 0 deaths
Stage 2: AGN-150998 3.0 mg
Serious events: 6 serious events
Other events: 35 other events
Deaths: 0 deaths
Stage 2: Ranibizumab 0.5 mg
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Stage 3: AGN-150998 2.0 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage 3: AGN-150998 1.0 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Stage 3: Ranibizumab 0.5 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: AGN-150998 4.2 mg
n=9 participants at risk
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 3.0 mg
n=6 participants at risk
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 2.0 mg
n=6 participants at risk
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 1.0 mg
n=3 participants at risk
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
|
Stage 2: AGN-150998 4.2 mg
n=67 participants at risk
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: AGN-150998 3.0 mg
n=58 participants at risk
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: Ranibizumab 0.5 mg
n=58 participants at risk
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 3: AGN-150998 2.0 mg
n=23 participants at risk
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: AGN-150998 1.0 mg
n=25 participants at risk
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: Ranibizumab 0.5 mg
n=16 participants at risk
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Uveitus
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.5%
3/67
|
3.4%
2/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
3.0%
2/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Vitritis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Choroiditis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Glaucoma
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
Other adverse events
| Measure |
Stage 1: AGN-150998 4.2 mg
n=9 participants at risk
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 3.0 mg
n=6 participants at risk
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
|
Stage 1: AGN-150998 2.0 mg
n=6 participants at risk
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
|
Stage 1: AGN-150998 1.0 mg
n=3 participants at risk
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
|
Stage 2: AGN-150998 4.2 mg
n=67 participants at risk
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: AGN-150998 3.0 mg
n=58 participants at risk
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 2: Ranibizumab 0.5 mg
n=58 participants at risk
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
|
Stage 3: AGN-150998 2.0 mg
n=23 participants at risk
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: AGN-150998 1.0 mg
n=25 participants at risk
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
|
Stage 3: Ranibizumab 0.5 mg
n=16 participants at risk
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Anterior chamber inflammation
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
3.0%
2/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Retinal pigment epithelial tear
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
1.7%
1/58
|
0.00%
0/58
|
4.3%
1/23
|
4.0%
1/25
|
0.00%
0/16
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/9
|
16.7%
1/6
|
16.7%
1/6
|
33.3%
1/3
|
13.4%
9/67
|
5.2%
3/58
|
8.6%
5/58
|
4.3%
1/23
|
8.0%
2/25
|
0.00%
0/16
|
|
Eye disorders
Eye irritation
|
0.00%
0/9
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/3
|
7.5%
5/67
|
3.4%
2/58
|
3.4%
2/58
|
4.3%
1/23
|
4.0%
1/25
|
0.00%
0/16
|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
3.0%
2/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Eye pain
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
9.0%
6/67
|
5.2%
3/58
|
6.9%
4/58
|
8.7%
2/23
|
4.0%
1/25
|
6.2%
1/16
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Macular oedema
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/3
|
6.0%
4/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
4.0%
1/25
|
6.2%
1/16
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3
|
9.0%
6/67
|
5.2%
3/58
|
6.9%
4/58
|
0.00%
0/23
|
12.0%
3/25
|
12.5%
2/16
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
0.00%
0/58
|
3.4%
2/58
|
4.3%
1/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
6.0%
4/67
|
3.4%
2/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
7.5%
5/67
|
10.3%
6/58
|
3.4%
2/58
|
8.7%
2/23
|
8.0%
2/25
|
0.00%
0/16
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
7.5%
5/67
|
5.2%
3/58
|
5.2%
3/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Eye disorders
Vitritis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
5.2%
3/58
|
0.00%
0/58
|
0.00%
0/23
|
4.0%
1/25
|
0.00%
0/16
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
5.2%
3/58
|
0.00%
0/58
|
4.3%
1/23
|
12.0%
3/25
|
6.2%
1/16
|
|
Eye disorders
Dry eye
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
5.2%
3/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Infections and infestations
Influenza
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
1.7%
1/58
|
5.2%
3/58
|
0.00%
0/23
|
0.00%
0/25
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
6.0%
4/67
|
3.4%
2/58
|
3.4%
2/58
|
4.3%
1/23
|
0.00%
0/25
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
5.2%
3/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
5.2%
3/58
|
5.2%
3/58
|
4.3%
1/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
3.0%
2/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
4.0%
1/25
|
6.2%
1/16
|
|
Eye disorders
Macular scar
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
12.5%
2/16
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
3.0%
2/67
|
0.00%
0/58
|
3.4%
2/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Eye disorders
Eye pruritus
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
1.7%
1/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
3.4%
2/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Eye disorders
Visual impairment
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
1.7%
1/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
1.7%
1/58
|
3.4%
2/58
|
4.3%
1/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
1.5%
1/67
|
3.4%
2/58
|
1.7%
1/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Vascular disorders
Hypertension
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
3.0%
2/67
|
0.00%
0/58
|
0.00%
0/58
|
4.3%
1/23
|
0.00%
0/25
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/3
|
3.0%
2/67
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER