Trial Outcomes & Findings for Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial. (NCT NCT00798317)
NCT ID: NCT00798317
Last Updated: 2014-12-17
Results Overview
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
326 participants
Primary outcome timeframe
Day 28
Results posted on
2014-12-17
Participant Flow
First patient was recruited on 23 Dec 2008 and last patient completed the study on 15 Jun 2010
Participant milestones
| Measure |
Ocriplasmin 125µg
125µg ocriplasmin intravitreal injection.
|
Placebo
Intravitreal injection of placebo
|
|---|---|---|
|
Overall Study
STARTED
|
245
|
81
|
|
Overall Study
COMPLETED
|
235
|
74
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Ocriplasmin 125µg
125µg ocriplasmin intravitreal injection.
|
Placebo
Intravitreal injection of placebo
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
Baseline characteristics by cohort
| Measure |
Ocriplasmin 125µg
n=245 Participants
125µg ocriplasmin intravitreal injection.
|
Placebo
n=81 Participants
Intravitreal injection of placebo
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Outcome measures
| Measure |
Ocriplasmin 125µg
n=245 Participants
125µg ocriplasmin intravitreal injection
|
Placebo
n=81 Participants
Intravitreal injection of placebo
|
|---|---|---|
|
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
|
25.3 percentage of participants
|
6.2 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Outcome measures
| Measure |
Ocriplasmin 125µg
n=245 Participants
125µg ocriplasmin intravitreal injection
|
Placebo
n=81 Participants
Intravitreal injection of placebo
|
|---|---|---|
|
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
|
10.6 percentage of participants
|
0 percentage of participants
|
Adverse Events
Ocriplasmin 125ug
Serious events: 33 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocriplasmin 125ug
n=245 participants at risk
125ug ocriplasmin intravitreal injection
|
Placebo
n=81 participants at risk
Intravitreal injection of placebo
|
|---|---|---|
|
Eye disorders
Macular hole
|
3.7%
9/245 • Number of events 9 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
6.2%
5/81 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Vitreous adhesions
|
1.2%
3/245 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Visual acuity reduced
|
0.82%
2/245 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Eye inflammation
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Hyphaema
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Macular oedema
|
0.00%
0/245 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Posterior capsule opacification
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Retinal detachment
|
0.00%
0/245 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Vitreous haemorrhage
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/245 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Upper limb fracture
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Wrist fracture
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Nervous system disorders
Syncope
|
0.82%
2/245 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Nervous system disorders
Epilepsy
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Nervous system disorders
Presyncope
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Transient ischaemic attack
|
0.00%
0/245 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Cardiac disorders
Angina unstable
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Arteriosclerosis coronay artery
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Cardiac disorders
Atrial fibrilation
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Cardiac disorders
Sick sinus syndrome
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Gastrointestinal disorders
Gastrointestinal haemorrahge
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Gastrointestinal disorders
Pancreatitis
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Infections and infestations
Diverticulitis
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Infections and infestations
Penumonia
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Musculoskeletal and connective tissue disorders
Reumathoid arthritis
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Metabolism and nutrition disorders
Dehydration
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Psychiatric disorders
Depression
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Renal and urinary disorders
Renal failure acute
|
0.41%
1/245 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
0.00%
0/81 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
Other adverse events
| Measure |
Ocriplasmin 125ug
n=245 participants at risk
125ug ocriplasmin intravitreal injection
|
Placebo
n=81 participants at risk
Intravitreal injection of placebo
|
|---|---|---|
|
Eye disorders
Vitreous floaters
|
15.5%
38/245 • Number of events 40 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
7.4%
6/81 • Number of events 8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Conjuctival haemorrahge
|
13.9%
34/245 • Number of events 34 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
12.3%
10/81 • Number of events 10 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Eye pain
|
12.2%
30/245 • Number of events 33 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
6.2%
5/81 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Photopsia
|
7.8%
19/245 • Number of events 21 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
1.2%
1/81 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Vision blurred
|
6.9%
17/245 • Number of events 18 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
3.7%
3/81 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Visual acuity reduced
|
5.3%
13/245 • Number of events 13 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
2.5%
2/81 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
|
Eye disorders
Macular oedema
|
5.3%
13/245 • Number of events 13 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
3.7%
3/81 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
AEs/SAEs were assessed by the investigator at all study visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Varying agreements. The most restrictive is as follows: The Centre and Investigator agree to neither publish nor make public any of the results of the Study without the prior written consent from Sponsor, which consent shall not be unreasonably withheld.
- Publication restrictions are in place
Restriction type: OTHER