Trial Outcomes & Findings for A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III) (NCT NCT00412958)
NCT ID: NCT00412958
Last Updated: 2014-12-17
Results Overview
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Day 7
Results posted on
2014-12-17
Participant Flow
The first patient was recruited on 29 Mar 2007 and the last patient completed the study on 02 Oct 2008.
Participant milestones
| Measure |
Ocriplasmin 25µg
25µg ocriplasmin intravitreal injection.
|
Ocriplasmin 75µg
75µg ocriplasmin intravitreal injection.
|
Ocriplasmin 125µg
125µg ocriplasmin intravitreal injection.
|
Placebo
Intravitreal injection of placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
33
|
32
|
31
|
|
Overall Study
COMPLETED
|
26
|
29
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ocriplasmin 25µg
25µg ocriplasmin intravitreal injection.
|
Ocriplasmin 75µg
75µg ocriplasmin intravitreal injection.
|
Ocriplasmin 125µg
125µg ocriplasmin intravitreal injection.
|
Placebo
Intravitreal injection of placebo.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Transport issue
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
Baseline characteristics by cohort
| Measure |
Ocriplasmin 25µg
n=29 Participants
25µg ocriplasmin intravitreal injection
|
Ocriplasmin 75µg
n=33 Participants
75µg ocriplasmin intravitreal injection.
|
Ocriplasmin 125µg
n=32 Participants
125µg ocriplasmin intravitreal injection.
|
Placebo
n=31 Participants
Intravitreal injection of placebo.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 9.07 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 11.60 • n=4 Participants
|
66.1 years
STANDARD_DEVIATION 10.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Intent-To-Treat (ITT). Full Analysis Set.
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
Outcome measures
| Measure |
Ocriplasmin 25µg
n=29 Participants
25µg ocriplasmin intravitreal injection.
|
Ocriplasmin 75µg
n=33 Participants
75µg ocriplasmin intravitreal injection.
|
Ocriplasmin 125µg
n=32 Participants
125µg ocriplasmin intravitreal injection.
|
Placebo
n=30 Participants
Intravitreal injection of placebo.
|
|---|---|---|---|---|
|
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
|
13.8 percentage of participants
|
18.2 percentage of participants
|
31.3 percentage of participants
|
10 percentage of participants
|
Adverse Events
Ocriplasmin 25µg
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Ocriplasmin 75µg
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Ocriplasmin 125µg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocriplasmin 25µg
n=29 participants at risk
25µg of ocriplasmin intravitreal injection.
|
Ocriplasmin 75µg
n=33 participants at risk
75µg of ocriplasmin intravitreal injection.
|
Ocriplasmin 125µg
n=32 participants at risk
125µg of ocriplasmin intravitreal injection.
|
Placebo
n=31 participants at risk
Intravitreal injection of placebo.
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Infections and infestations
Sinutis
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Anterior chamber inflammation
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bening pancreatic neoplasm
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Vascular disorders
Hypertension
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
Other adverse events
| Measure |
Ocriplasmin 25µg
n=29 participants at risk
25µg of ocriplasmin intravitreal injection.
|
Ocriplasmin 75µg
n=33 participants at risk
75µg of ocriplasmin intravitreal injection.
|
Ocriplasmin 125µg
n=32 participants at risk
125µg of ocriplasmin intravitreal injection.
|
Placebo
n=31 participants at risk
Intravitreal injection of placebo.
|
|---|---|---|---|---|
|
Eye disorders
Photopsia
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Cataract cortical
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Conjunctival haemorrahge
|
48.3%
14/29 • Number of events 17 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
54.5%
18/33 • Number of events 22 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
53.1%
17/32 • Number of events 18 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
71.0%
22/31 • Number of events 22 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Anterior chamber cell
|
41.4%
12/29 • Number of events 13 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
39.4%
13/33 • Number of events 17 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
40.6%
13/32 • Number of events 16 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
22.6%
7/31 • Number of events 8 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Anterior chamber flare
|
20.7%
6/29 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
21.2%
7/33 • Number of events 9 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
34.4%
11/32 • Number of events 12 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
19.4%
6/31 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Cataract nuclear
|
31.0%
9/29 • Number of events 13 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
21.2%
7/33 • Number of events 8 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
25.0%
8/32 • Number of events 9 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
25.8%
8/31 • Number of events 12 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Macular oedema
|
17.2%
5/29 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
30.3%
10/33 • Number of events 11 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.5%
4/32 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
22.6%
7/31 • Number of events 8 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Cataract
|
20.7%
6/29 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
27.3%
9/33 • Number of events 9 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
21.9%
7/32 • Number of events 9 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
16.1%
5/31 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Eye pain
|
20.7%
6/29 • Number of events 7 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
27.3%
9/33 • Number of events 11 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.5%
4/32 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
25.8%
8/31 • Number of events 11 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Eyelid oedema
|
24.1%
7/29 • Number of events 8 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.1%
3/33 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.4%
3/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
22.6%
7/31 • Number of events 7 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal haemorrhage
|
24.1%
7/29 • Number of events 9 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
18.2%
6/33 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
15.6%
5/32 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
22.6%
7/31 • Number of events 9 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal tear
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
21.2%
7/33 • Number of events 7 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.5%
4/32 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal depigmentation
|
20.7%
6/29 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
18.2%
6/33 • Number of events 7 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
18.8%
6/32 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.9%
4/31 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Ocular discomfort
|
17.2%
5/29 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.5%
4/32 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
16.1%
5/31 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Maculopathy
|
13.8%
4/29 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
15.2%
5/33 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
16.1%
5/31 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Vitreous floaters
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
15.2%
5/33 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.5%
4/32 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
16.1%
5/31 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Ocular hyperaemia
|
13.8%
4/29 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.4%
3/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal disorder
|
10.3%
3/29 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.1%
3/33 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.5%
4/32 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.1%
4/33 • Number of events 8 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Macular degeneration
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.1%
4/33 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Vitreous haemorrhage
|
6.9%
2/29 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.1%
4/33 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Anterior chamber inflammation
|
10.3%
3/29 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Conjunctival oedema
|
10.3%
3/29 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Photophobia
|
10.3%
3/29 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Visual disturbance
|
10.3%
3/29 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Foreign body sensation in eyes
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.1%
3/33 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.4%
3/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.7%
3/31 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Conjunctival hyperaemia
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.4%
3/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Corneal disorder
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.4%
3/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Lacrimation increased
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.1%
3/33 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.1%
3/33 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Vitreous disorder
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.1%
3/33 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Corneal bleeding
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Eye pruritus
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Corneal oedema
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/33 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal cyst
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Macular hole
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Corneal striae
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Eye inflammation
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal degeneration
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Investigations
Intraocular pressure increased
|
13.8%
4/29 • Number of events 4 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
12.1%
4/33 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
18.8%
6/32 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
16.1%
5/31 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Investigations
Intraocular pressure decreased
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.5%
2/31 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
16.1%
5/31 • Number of events 6 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.2%
2/32 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
15.2%
5/33 • Number of events 5 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.1%
1/32 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.2%
1/31 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
General disorders
Oedema peripheral
|
6.9%
2/29 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
3.0%
1/33 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
General disorders
Asthenia
|
0.00%
0/29 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/32 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
|
Eye disorders
Retinal oedema
|
3.4%
1/29 • Number of events 1 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
6.1%
2/33 • Number of events 2 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
9.4%
3/32 • Number of events 3 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
0.00%
0/31 • Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
AEs/SAEs were assessed by the investigator at all study visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60