Trial Outcomes & Findings for VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration) (NCT NCT01482910)
NCT ID: NCT01482910
Last Updated: 2016-11-04
Results Overview
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Baseline and at week 28
Results posted on
2016-11-04
Participant Flow
Participant milestones
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
|
PDT Treatments
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
76
|
|
Overall Study
Completed Week 28
|
216
|
71
|
|
Overall Study
COMPLETED
|
213
|
67
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
|
PDT Treatments
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Baseline characteristics by cohort
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=228 Participants
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
|
PDT Treatments
n=76 Participants
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 Years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
64.9 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
65.1 Years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
196 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and at week 28Population: Full analysis set
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=228 Participants
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
|
PDT Treatments
n=76 Participants
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
|
|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)
|
14.0 Letters correctly read
Standard Deviation 12.1
|
3.9 Letters correctly read
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: At week 28Population: Full analysis set
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=228 Participants
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
|
PDT Treatments
n=76 Participants
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
|
|---|---|---|
|
Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF
|
98.7 Percentage of participants
|
92.1 Percentage of participants
|
Adverse Events
Aflibercept Injection, up to Week 28
Serious events: 13 serious events
Other events: 77 other events
Deaths: 0 deaths
PDT Treatments, up to Week 28
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Aflibercept Injection, From Week 28 to Week 52
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
PDT Then Aflibercept Injection, From Week 28 to Week 52
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept Injection, up to Week 28
n=228 participants at risk
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
|
PDT Treatments, up to Week 28
n=76 participants at risk
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
|
Aflibercept Injection, From Week 28 to Week 52
n=216 participants at risk
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
|
PDT Then Aflibercept Injection, From Week 28 to Week 52
n=71 participants at risk
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.4%
1/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.46%
1/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Cataract
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.4%
1/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Visual acuity reduced
|
0.88%
2/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
3.9%
3/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.46%
1/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.46%
1/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Infections and infestations
Pneumonia
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.3%
1/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.4%
1/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.46%
1/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Vascular disorders
Hypertension
|
0.00%
0/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.46%
1/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
Other adverse events
| Measure |
Aflibercept Injection, up to Week 28
n=228 participants at risk
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
|
PDT Treatments, up to Week 28
n=76 participants at risk
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
|
Aflibercept Injection, From Week 28 to Week 52
n=216 participants at risk
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
|
PDT Then Aflibercept Injection, From Week 28 to Week 52
n=71 participants at risk
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
6.1%
14/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
5.3%
4/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
6.0%
13/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
5.6%
4/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Retinal haemorrhage
|
3.9%
9/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
5.3%
4/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Retinal pigment epitheliopathy
|
5.3%
12/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
10.5%
8/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
2.8%
6/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.4%
1/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Visual acuity reduced
|
7.0%
16/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
14.5%
11/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
2.8%
6/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
7.0%
5/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Subretinal fluid
|
0.88%
2/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
5.3%
4/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.93%
2/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.4%
1/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Eye disorders
Macular fibrosis
|
11.8%
27/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
10.5%
8/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
2.8%
6/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
10/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
5.3%
4/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
2.8%
6/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.00%
0/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
|
Investigations
Intraocular pressure increased
|
5.3%
12/228 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
2.6%
2/76 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
0.93%
2/216 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
1.4%
1/71 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60