Trial Outcomes & Findings for A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt) (NCT NCT00435539)
NCT ID: NCT00435539
Last Updated: 2014-12-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Day 14
Results posted on
2014-12-17
Participant Flow
The first patient was enrolled on 2 March 2007 and the last patient completed the last visit on 8 January 2009. All patients were selected in medical clinics
All subjects in all cohorts had a similar follow-up schedule to the day 28 post-injection visit. After day 28, non-responders in cohort 4 received up to 2 repeated injections and thus had a different study follow-up schedule than all other subjects.
Participant milestones
| Measure |
Ocriplasmin 75µg Single Injection
Ocriplasmin 75µg single injection versus sham injection
|
Ocriplasmin 125µg Single Injection
ocriplasmin 125µg single injection versus sham injection
|
Ocriplasmin 175µg Single Injection
ocriplasmin 175µg single injection versus sham injection
|
Ocriplasmin 125µg Multiple Injections
ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
|
Sham Injection
sham injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
11
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
13
|
11
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)
Baseline characteristics by cohort
| Measure |
Ocriplasmin 75µg Single Injection
n=12 Participants
ocriplasmin 75µg single injection versus sham injection
|
Ocriplasmin 125µg Single Injection
n=13 Participants
ocriplasmin 125µg single injection versus sham injection
|
Ocriplasmin 175µg Single Injection
n=11 Participants
ocriplasmin 175µg single injection versus sham injection
|
Ocriplasmin 125µg Multiple Injections
n=12 Participants
ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
|
Sham Injection
n=12 Participants
sham injection
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.58 years
STANDARD_DEVIATION 5.57 • n=93 Participants
|
74.67 years
STANDARD_DEVIATION 5.78 • n=4 Participants
|
66.11 years
STANDARD_DEVIATION 9.08 • n=27 Participants
|
70.61 years
STANDARD_DEVIATION 6.67 • n=483 Participants
|
70.28 years
STANDARD_DEVIATION 8.58 • n=36 Participants
|
69.79 years
STANDARD_DEVIATION 7.66 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
33 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Intention to Treat (ITT)
Outcome measures
| Measure |
Ocriplasmin 75µg Single Injection
n=11 Participants
Ocriplasmin 75µg single injection versus sham injection
|
Ocriplasmin 175µg Single Injection
n=11 Participants
Ocriplasmin 175µg single injection versus sham injection
|
Ocriplasmin 125µg Pooled
n=22 Participants
Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
|
Sham Injection
n=11 Participants
sham injection
|
|---|---|---|---|---|
|
Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
|
18.2 percentage of participants
|
18.2 percentage of participants
|
13.6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: Intention to Treat (ITT)
Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.
Outcome measures
| Measure |
Ocriplasmin 75µg Single Injection
n=12 Participants
Ocriplasmin 75µg single injection versus sham injection
|
Ocriplasmin 175µg Single Injection
n=11 Participants
Ocriplasmin 175µg single injection versus sham injection
|
Ocriplasmin 125µg Pooled
n=25 Participants
Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
|
Sham Injection
n=12 Participants
sham injection
|
|---|---|---|---|---|
|
Resolution of Vitreomacular Traction (Investigator's Assessment)
|
25 Percentage of participants
|
27.3 Percentage of participants
|
11 Percentage of participants
|
8.3 Percentage of participants
|
Adverse Events
Ocriplasmin 75µg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Ocriplasmin 125µg Single Injection
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Ocriplasmin 175µg Single Injection
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Ocriplasmin 125µg Multiple Injection
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Sham Injection
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocriplasmin 75µg
n=12 participants at risk
Ocriplasmin 75µg single injection versus sham injection
|
Ocriplasmin 125µg Single Injection
n=13 participants at risk
Ocriplasmin 125µg single injection versus sham injection
|
Ocriplasmin 175µg Single Injection
n=11 participants at risk
Ocriplasmin 175µg single injection versus sham injection
|
Ocriplasmin 125µg Multiple Injection
n=12 participants at risk
Ocriplasmin 125µg multiple injection versus sham injection
|
Sham Injection
n=12 participants at risk
Sham injection
|
|---|---|---|---|---|---|
|
Eye disorders
Retinal vein occlusion
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Macular hole
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
27.3%
3/11 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Cardiac disorders
Silent Myocardial infarction
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
Other adverse events
| Measure |
Ocriplasmin 75µg
n=12 participants at risk
Ocriplasmin 75µg single injection versus sham injection
|
Ocriplasmin 125µg Single Injection
n=13 participants at risk
Ocriplasmin 125µg single injection versus sham injection
|
Ocriplasmin 175µg Single Injection
n=11 participants at risk
Ocriplasmin 175µg single injection versus sham injection
|
Ocriplasmin 125µg Multiple Injection
n=12 participants at risk
Ocriplasmin 125µg multiple injection versus sham injection
|
Sham Injection
n=12 participants at risk
Sham injection
|
|---|---|---|---|---|---|
|
Eye disorders
Vitreous floaters
|
33.3%
4/12 • Number of events 4 • AEs/SAEs were collected from injection day up to 6 months after injection
|
23.1%
3/13 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
36.4%
4/11 • Number of events 4 • AEs/SAEs were collected from injection day up to 6 months after injection
|
58.3%
7/12 • Number of events 9 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Vitritis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
23.1%
3/13 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
33.3%
4/12 • Number of events 4 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Macular hole
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Conjuctival hyperaemia
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
15.4%
2/13 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
25.0%
3/12 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Conjunctival haemorrhage
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Macular oedema
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Macular pseudohole
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Anterior chamber cell
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Cataract
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Corneal oedema
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Keratitis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Macular scar
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Maculopathy
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Meibomianitis
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Optic nerve cupping
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Papilloedema
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Vitreous opacities
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Blepharitis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
15.4%
2/13 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
27.3%
3/11 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
15.4%
2/13 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Infections and infestations
Tracheitis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Investigations
Intraocular pressure increased
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
27.3%
3/11 • Number of events 3 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
16.7%
2/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Immune system disorders
Systemic lupus erythematosus
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
9.1%
1/11 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Musculoskeletal and connective tissue disorders
Ostheoarthritis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Endocrine disorders
Hypoglycaemia
|
8.3%
1/12 • Number of events 2 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/13 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
8.3%
1/12 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
|
Cardiac disorders
Dyspnoea
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
7.7%
1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/11 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
0.00%
0/12 • AEs/SAEs were collected from injection day up to 6 months after injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60