Trial Outcomes & Findings for Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (NCT NCT04864834)
NCT ID: NCT04864834
Last Updated: 2024-03-26
Results Overview
The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
485 participants
Primary outcome timeframe
Change from baseline in mean BCVA score at Week 8
Results posted on
2024-03-26
Participant Flow
485 subjects were randomized in the study, and 484 subjects received at least 1 dose of SOK583 or Eylea EU and comprised the Safety Set. Of these 484 subject, 1 subject in the SOK583 group had no post-baseline BCVA assessments and was therefore excluded from the Full Analysis Set. The Full Analysis Set therefore comprises 483 subjects.
Participant milestones
| Measure |
SOK583A1 (40 mg/mL)
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Overall Study
STARTED
|
245
|
240
|
|
Overall Study
Safety Set
|
244
|
240
|
|
Overall Study
Full Analysis Set
|
243
|
240
|
|
Overall Study
Per-Protocol Set
|
235
|
226
|
|
Overall Study
PK Analysis Set
|
23
|
20
|
|
Overall Study
Immunogenicity Analysis Set
|
234
|
231
|
|
Overall Study
VEGF Analysis Set
|
60
|
67
|
|
Overall Study
COMPLETED
|
216
|
215
|
|
Overall Study
NOT COMPLETED
|
29
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
SOK583A1 (40 mg/mL)
n=243 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=240 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.8 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
75.7 years
STANDARD_DEVIATION 7.72 • n=7 Participants
|
75.7 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
|
Age, Customized
<75 years
|
103 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Age, Customized
≥75 years
|
140 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
225 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
215 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
158 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in mean BCVA score at Week 8Population: Per-Protocol Set
The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=235 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=226 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline.
|
6.5 BCVA score in letters
Standard Deviation 8.98
|
6.8 BCVA score in letters
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Week 1, 4, 8, 24 and 52Population: Full Analysis Set (subjects with baseline value). Results are provided for subjects with data available at a certain visit.
Mean change in CSFT using SD-OCT from Baseline to Week 1, 4, 8, 24 and 52 CSFT: Central Subfield Thickness SD-OCT: Spectral-Domain Optical Coherence Tomography
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=243 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=238 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 1
|
-103.6 μm
Standard Deviation 89.91
|
-99.2 μm
Standard Deviation 86.18
|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 4
|
-152.9 μm
Standard Deviation 123.55
|
-140.7 μm
Standard Deviation 120.25
|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 8
|
-165.7 μm
Standard Deviation 144.35
|
-154.2 μm
Standard Deviation 133.43
|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 24
|
-136.4 μm
Standard Deviation 140.19
|
-127.5 μm
Standard Deviation 137.87
|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 52
|
-187.9 μm
Standard Deviation 150.70
|
-172.9 μm
Standard Deviation 142.74
|
SECONDARY outcome
Timeframe: Week 8 and 52Population: Full Analysis Set (subjects with baseline value). Results are provided for subjects with data available at a certain visit.
Mean change of CNV lesion size using FA from Screening to Week 8 and 52 CNV: Choroidal neovascularization FA: Fundus Angiography
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=242 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=237 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 8
|
-1.7877 mm^2
Standard Deviation 3.97567
|
-1.7274 mm^2
Standard Deviation 3.77398
|
|
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Week 52
|
-3.7845 mm^2
Standard Deviation 5.21911
|
-3.5026 mm^2
Standard Deviation 4.96036
|
SECONDARY outcome
Timeframe: Week 24 and 52Population: Full Analysis Set (subjects with baseline value). Results are provided for subjects with data available at a certain visit.
Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=243 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=240 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA
Week 24
|
6.9 score on a scale
Standard Deviation 8.93
|
7.4 score on a scale
Standard Deviation 9.95
|
|
Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA
Week 52
|
6.4 score on a scale
Standard Deviation 11.91
|
7.7 score on a scale
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety Analysis Set
Number and proportion of subjects with ocular and non-ocular Adverse Events (AEs) over 52 weeks including serious AEs, regardless of relationship to study treatment
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=244 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=240 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Similarity Between SOK583A1 and Eylea EU in Terms of Safety
Ocular AEs in the study eye
|
84 Participants
|
78 Participants
|
|
Similarity Between SOK583A1 and Eylea EU in Terms of Safety
Ocular AEs in the fellow eye
|
55 Participants
|
51 Participants
|
|
Similarity Between SOK583A1 and Eylea EU in Terms of Safety
Non-ocular AEs
|
141 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Immunogenicity analysis set including all randomized subjects who received at least 1 dose of study treatment and had immunogenicity blood samples collected and analyzed at baseline and at least 1 post-baseline time point. Subjects with positive ADA results at baseline were excluded from the IAS. Subjects who received both treatments into the study eye were excluded from the IAS. Subjects were analyzed according to the study treatment received.
Development of binding and neutralizing Anti-drug antibodies (ADAs) up to Week 52
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=234 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=231 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity
ADA positive
|
2 Participants
|
6 Participants
|
|
Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity
ADA negative
|
232 Participants
|
225 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58)Population: PK Analysis Set
Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=23 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=20 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment
Day 58
|
31.7 ng/ml
Standard Deviation 21.9
|
33.6 ng/ml
Standard Deviation 25.8
|
|
Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment
Day 1 (Baseline)
|
0.0 ng/ml
Standard Deviation 0.0
|
0.0 ng/ml
Standard Deviation 0.0
|
|
Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment
Day 2
|
32.0 ng/ml
Standard Deviation 24.0
|
33.3 ng/ml
Standard Deviation 24.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessment at Week 48 (pre-dose) and Week 52Population: VEGF Analysis Set
Mean VEGF concentrations
Outcome measures
| Measure |
SOK583A1 (40 mg/mL)
n=60 Participants
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
Eylea EU (40 mg/mL)
n=67 Participants
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
|
|---|---|---|
|
Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept
Week 48 (pre-dose)
|
86.44 pg/mL
Standard Deviation 77.962
|
80.09 pg/mL
Standard Deviation 92.155
|
|
Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept
Week 52
|
75.14 pg/mL
Standard Deviation 20.892
|
73.38 pg/mL
Standard Deviation 20.169
|
Adverse Events
SOK583
Serious events: 39 serious events
Other events: 58 other events
Deaths: 5 deaths
Eylea EU
Serious events: 30 serious events
Other events: 63 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SOK583
n=244 participants at risk
SOK583
|
Eylea EU
n=240 participants at risk
Eylea EU
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
4/244 • 52 weeks
|
0.83%
2/240 • 52 weeks
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.82%
2/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Eye disorders
Retinal haemorrhage
|
0.82%
2/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Eye disorders
Visual impairment
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
General disorders
Chest pain
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
General disorders
Death
|
1.2%
3/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/244 • 52 weeks
|
0.83%
2/240 • 52 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Infections and infestations
Diverticulitis
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Infections and infestations
Peritonitis
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/244 • 52 weeks
|
0.83%
2/240 • 52 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.82%
2/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Investigations
Blood pressure increased
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Nervous system disorders
Aphasia
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.82%
2/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Nervous system disorders
Syncope
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Product Issues
Device malfunction
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
1/244 • 52 weeks
|
0.83%
2/240 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
|
Vascular disorders
Circulatory collapse
|
0.41%
1/244 • 52 weeks
|
0.00%
0/240 • 52 weeks
|
|
Vascular disorders
Hypertension
|
0.41%
1/244 • 52 weeks
|
0.42%
1/240 • 52 weeks
|
Other adverse events
| Measure |
SOK583
n=244 participants at risk
SOK583
|
Eylea EU
n=240 participants at risk
Eylea EU
|
|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
10.2%
25/244 • 52 weeks
|
10.4%
25/240 • 52 weeks
|
|
Eye disorders
Visual acuity reduced
|
4.5%
11/244 • 52 weeks
|
5.0%
12/240 • 52 weeks
|
|
Infections and infestations
COVID-19
|
7.8%
19/244 • 52 weeks
|
9.6%
23/240 • 52 weeks
|
|
Vascular disorders
Hypertension
|
4.5%
11/244 • 52 weeks
|
6.7%
16/240 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Sandoz agreements with its investigators may vary. However, Sandoz does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the pooled date (i.e. data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER