Trial Outcomes & Findings for Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD (NCT NCT01414153)
NCT ID: NCT01414153
Last Updated: 2016-10-17
Results Overview
Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Baseline to Day 120
Results posted on
2016-10-17
Participant Flow
Participant milestones
| Measure |
Monotherapy
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
39
|
41
|
|
Overall Study
COMPLETED
|
30
|
38
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD
Baseline characteristics by cohort
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
76.1 years
STANDARD_DEVIATION 7.53 • n=99 Participants
|
77.2 years
STANDARD_DEVIATION 7.43 • n=107 Participants
|
77.6 years
STANDARD_DEVIATION 7.86 • n=206 Participants
|
76.5 years
STANDARD_DEVIATION 7.95 • n=157 Participants
|
76.8 years
STANDARD_DEVIATION 7.65 • n=390 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
83 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
75 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
10 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
38 Participants
n=157 Participants
|
148 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
40 Participants
n=157 Participants
|
154 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
39 participants
n=206 Participants
|
41 participants
n=157 Participants
|
158 participants
n=390 Participants
|
|
Best Corrected Visual Acuity (ETDRS)
|
56.2 letters
STANDARD_DEVIATION 15.84 • n=99 Participants
|
58.7 letters
STANDARD_DEVIATION 10.75 • n=107 Participants
|
61.3 letters
STANDARD_DEVIATION 9.20 • n=206 Participants
|
63.2 letters
STANDARD_DEVIATION 7.88 • n=157 Participants
|
59 letters
STANDARD_DEVIATION 11.45 • n=390 Participants
|
|
Choroidal neovascularization (CNV) Lesion Type
Predominantly Classic
|
10.5 percentage of participants
n=99 Participants
|
15.0 percentage of participants
n=107 Participants
|
12.8 percentage of participants
n=206 Participants
|
22.0 percentage of participants
n=157 Participants
|
60.3 percentage of participants
n=390 Participants
|
|
Choroidal neovascularization (CNV) Lesion Type
Minimally Classic
|
5.3 percentage of participants
n=99 Participants
|
5.0 percentage of participants
n=107 Participants
|
5.1 percentage of participants
n=206 Participants
|
7.3 percentage of participants
n=157 Participants
|
22.7 percentage of participants
n=390 Participants
|
|
Choroidal neovascularization (CNV) Lesion Type
Occult
|
76.3 percentage of participants
n=99 Participants
|
77.5 percentage of participants
n=107 Participants
|
79.5 percentage of participants
n=206 Participants
|
61.0 percentage of participants
n=157 Participants
|
294.3 percentage of participants
n=390 Participants
|
|
Choroidal neovascularization (CNV) Lesion Type
Unreadable
|
5.3 percentage of participants
n=99 Participants
|
0.0 percentage of participants
n=107 Participants
|
0.0 percentage of participants
n=206 Participants
|
2.4 percentage of participants
n=157 Participants
|
7.7 percentage of participants
n=390 Participants
|
|
Choroidal neovascularization (CNV) Lesion Type
Missing
|
2.6 percentage of participants
n=99 Participants
|
2.5 percentage of participants
n=107 Participants
|
2.6 percentage of participants
n=206 Participants
|
7.3 percentage of participants
n=157 Participants
|
15 percentage of participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 120Population: Intent-to-treat (ITT) Population
Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.
Outcome measures
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)
|
-3.17 letters
Standard Deviation 1.515
|
4.22 letters
Standard Deviation 1.459
|
3.63 letters
Standard Deviation 1.478
|
4.34 letters
Standard Deviation 1.455
|
SECONDARY outcome
Timeframe: Baseline to Day 120Population: ITT population
Outcome measures
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=40 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Mean Change in Central Subfield Retinal Thickness
|
12.9 μM
Standard Error 12.45
|
-72.4 μM
Standard Error 12.06
|
-46.9 μM
Standard Error 12.20
|
-67.7 μM
Standard Error 12.07
|
SECONDARY outcome
Timeframe: Baseline to Day 120Population: ITT population
Outcome measures
| Measure |
Monotherapy
n=30 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=40 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).
|
0.02 mm^2
Standard Error 0.793
|
-4.91 mm^2
Standard Error 0.765
|
-4.71 mm^2
Standard Error 0.775
|
-5.30 mm^2
Standard Error 0.762
|
SECONDARY outcome
Timeframe: Baseline to Day 120Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.
Outcome measures
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.
≥ 15 letters gained
|
5.3 percentage of subjects
Interval 1.4 to 13.4
|
15.0 percentage of subjects
Interval 8.1 to 24.8
|
5.1 percentage of subjects
Interval 1.4 to 13.1
|
0 percentage of subjects
Interval 0.0 to 5.5
|
|
Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.
≥ 0 letters gained
|
44.7 percentage of subjects
Interval 33.5 to 56.4
|
72.5 percentage of subjects
Interval 61.5 to 81.7
|
71.8 percentage of subjects
Interval 60.6 to 81.2
|
80.5 percentage of subjects
Interval 70.2 to 88.3
|
|
Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.
≥ 5 letters gained
|
23.7 percentage of subjects
Interval 14.8 to 34.8
|
42.5 percentage of subjects
Interval 31.7 to 53.9
|
46.2 percentage of subjects
Interval 35.0 to 57.6
|
53.7 percentage of subjects
Interval 42.5 to 64.5
|
|
Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.
≥ 10 letters gained
|
13.2 percentage of subjects
Interval 6.5 to 23.0
|
22.5 percentage of subjects
Interval 14.1 to 33.2
|
28.2 percentage of subjects
Interval 18.8 to 39.4
|
22.0 percentage of subjects
Interval 13.7 to 32.4
|
SECONDARY outcome
Timeframe: Baseline to Day 120Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. One line is equivalent to 5 letters, so a loss of 3 lines is a loss of 15 letters.
Outcome measures
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.
≥ 15 letters lost
|
10.5 percentage of subjects
Interval 4.7 to 19.9
|
2.5 percentage of subjects
Interval 0.3 to 9.4
|
5.1 percentage of subjects
Interval 1.4 to 13.1
|
0.0 percentage of subjects
Interval 0.0 to 5.5
|
|
Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.
≥ 1 letters lost
|
55.3 percentage of subjects
Interval 43.6 to 66.5
|
27.5 percentage of subjects
Interval 18.3 to 38.5
|
28.2 percentage of subjects
Interval 18.8 to 39.4
|
19.5 percentage of subjects
Interval 11.7 to 29.8
|
|
Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.
≥ 5 letters lost
|
44.7 percentage of subjects
Interval 33.5 to 56.4
|
12.5 percentage of subjects
Interval 6.2 to 22.0
|
17.9 percentage of subjects
Interval 10.3 to 28.3
|
7.3 percentage of subjects
Interval 2.7 to 15.6
|
|
Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.
≥ 10 letters lost
|
18.4 percentage of subjects
Interval 10.6 to 29.0
|
7.5 percentage of subjects
Interval 2.8 to 15.9
|
10.3 percentage of subjects
Interval 4.5 to 19.5
|
2.4 percentage of subjects
Interval 0.3 to 9.2
|
SECONDARY outcome
Timeframe: Baseline to Day 120Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. 20/40 Snellen corresponds to a range of 69-73 letters by ETDRS.
Outcome measures
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Proportion of Subjects With ETDRS BCVA of 20/40 or Better.
|
26.3 percentage of subjects
Interval 17.0 to 37.6
|
47.5 percentage of subjects
Interval 36.4 to 58.8
|
41 percentage of subjects
Interval 30.2 to 52.6
|
56.1 percentage of subjects
Interval 44.9 to 66.8
|
SECONDARY outcome
Timeframe: Baseline to Day 120Outcome measures
| Measure |
Monotherapy
n=38 Participants
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 Participants
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 Participants
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 Participants
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Proportion of Subjects With Adverse Events.
|
81.6 percentage of subjects
|
80.0 percentage of subjects
|
82.1 percentage of subjects
|
75.6 percentage of subjects
|
Adverse Events
Monotherapy
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
0.5 mg iSONEP & Lucentis/Avastin/Eylea
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
4.0 mg iSONEP & Lucentis/Avastin/Eylea
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Lucentis or Avastin or Eylea
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy
n=38 participants at risk
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 participants at risk
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 participants at risk
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 participants at risk
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Cardiac disorders
angina unstable
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.3%
3/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Cardiac disorders
cardiac failure congestive
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Cardiac disorders
sick sinus syndrome
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
optic ischaemic neuropathy
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Gastrointestinal disorders
lower gastrointestinal haemorrhage
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Gastrointestinal disorders
upper gastrointestinal bleed
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
General disorders
chest pain
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Immune system disorders
anaphylactic reaction
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
pneumonia
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Injury, poisoning and procedural complications
pelvic fracture
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Metabolism and nutrition disorders
dehydration
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung adenocarcinoma
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer metastatic
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
small cell lung cancer
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Vascular disorders
hypotension
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
Other adverse events
| Measure |
Monotherapy
n=38 participants at risk
4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
|
0.5 mg iSONEP & Lucentis/Avastin/Eylea
n=40 participants at risk
0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
4.0 mg iSONEP & Lucentis/Avastin/Eylea
n=39 participants at risk
4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
|
Lucentis or Avastin or Eylea
n=41 participants at risk
0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Age-related macular degeneration
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Anterior chamber cell
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Conjunctival haemorrhage
|
34.2%
13/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
60.0%
24/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
53.8%
21/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
41.5%
17/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Corneal oedema
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Eye irritation
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Eye pain
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
15.4%
6/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.3%
3/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Eye pruritus
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Macular degeneration
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Punctate keratitis
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Retinal haemorrhage
|
28.9%
11/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Visual acuity reduced
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Vitreous detachment
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.6%
1/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.3%
3/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Eye disorders
Vitreous floaters
|
7.9%
3/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
12.5%
5/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
20.5%
8/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
12.2%
5/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
Cystitis
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
10.0%
4/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.3%
3/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
Sinusitis
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Infections and infestations
Urinary tract infection
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.5%
3/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
9.8%
4/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
12.5%
5/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
28.2%
11/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
3/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.5%
1/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
2.4%
1/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.3%
3/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Vascular disorders
Hypertension
|
2.6%
1/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.0%
2/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
7.7%
3/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
4.9%
2/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
|
Vascular disorders
Hypotension
|
0.00%
0/38 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/40 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
5.1%
2/39 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
0.00%
0/41 • Adverse events were collected from the time of consent through the last study visit.
Adverse events presented here are those that were treatment-emergent (those with an onset date on or after the time of first dose).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60