Trial Outcomes & Findings for UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD) (NCT NCT01988662)
NCT ID: NCT01988662
Last Updated: 2017-05-03
Results Overview
Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
205 participants
Primary outcome timeframe
Change from baseline at Month 3
Results posted on
2017-05-03
Participant Flow
All randomized patients were included in the Full Analysis Set (FAS).
Participant milestones
| Measure |
Ranibizumab
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
101
|
|
Overall Study
COMPLETED
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Ranibizumab
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Overall Study
Subject/guardian decision
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
Baseline Characteristics
UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=104 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.1 Years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
72.0 Years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
71.0 Years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at Month 3Population: Full Analysis Set (FAS): The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.
Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=99 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
|
41.04 Percent change
Standard Error 19.918
|
-21.53 Percent change
Standard Error 20.398
|
SECONDARY outcome
Timeframe: Change from baseline up to month 3Population: FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.
Plasma VEGF measurement performed at all visits and compared to baseline level
Outcome measures
| Measure |
Ranibizumab
n=104 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Month 3 (n=100, 99)
|
41.04 Percent change
Standard Error 19.918
|
-21.53 Percent change
Standard Error 20.398
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Baseline (post-IVT injection; n=104, 100)
|
11.93 Percent change
Standard Error 5.836
|
-9.37 Percent change
Standard Error 6.100
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Week 1 (n=103, 101)
|
44.08 Percent change
Standard Error 14.377
|
-7.44 Percent change
Standard Error 14.722
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Week 2 (n=102, 100)
|
38.76 Percent change
Standard Error 11.165
|
-16.45 Percent change
Standard Error 11.434
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Month 1 (pre-IVT injection; n= 102, 100))
|
112.05 Percent change
Standard Error 60.182
|
23.12 Percent change
Standard Error 61.641
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Month 1 (post-IVT injection; n=101, 100)
|
12.27 Percent change
Standard Error 6.711
|
-20.61 Percent change
Standard Error 6.861
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Month 2 (pre-IVT injection; n=100, 99)
|
10.78 Percent change
Standard Error 7.342
|
-19.13 Percent change
Standard Error 7.519
|
|
Percent Change From Baseline in Plasma VEGF Level Overtime
Month 2 (post-IVT injection; n=100, 99)
|
50.59 Percent change
Standard Error 19.076
|
-16.09 Percent change
Standard Error 19.535
|
SECONDARY outcome
Timeframe: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3Population: FAS
VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.
Outcome measures
| Measure |
Ranibizumab
n=104 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Baseline (post-IVT injection)
|
-0.141 pearson correlation coefficient
Interval -0.34 to 0.07
|
0.083 pearson correlation coefficient
Interval -0.12 to 0.28
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Week 1
|
0.027 pearson correlation coefficient
Interval -0.17 to 0.22
|
0.234 pearson correlation coefficient
Interval 0.04 to 0.41
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Week 2
|
-0.085 pearson correlation coefficient
Interval -0.28 to 0.11
|
0.192 pearson correlation coefficient
Interval -0.01 to 0.37
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Month 1 (pre-IVT injection)
|
-0.065 pearson correlation coefficient
Interval -0.26 to 0.13
|
0.127 pearson correlation coefficient
Interval -0.07 to 0.32
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Month 1 (post-IVT injection)
|
-0.110 pearson correlation coefficient
Interval -0.3 to 0.09
|
0.088 pearson correlation coefficient
Interval -0.11 to 0.28
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Month 2 (pre-IVT injection)
|
-0.151 pearson correlation coefficient
Interval -0.34 to 0.05
|
0.051 pearson correlation coefficient
Interval -0.15 to 0.25
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Month 2 (post-IVT injection)
|
-0.049 pearson correlation coefficient
Interval -0.25 to 0.15
|
0.098 pearson correlation coefficient
Interval -0.1 to 0.29
|
|
Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Month 3
|
-0.047 pearson correlation coefficient
Interval -0.24 to 0.15
|
0.229 pearson correlation coefficient
Interval 0.03 to 0.41
|
SECONDARY outcome
Timeframe: Baseline, month 1, month 2, month 3Population: FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.
BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity. Change from baseline calculated as observed post-baseline value - baseline value.
Outcome measures
| Measure |
Ranibizumab
n=104 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
Change at month 1 (n= 99, 100)
|
3.9 Letter
Standard Deviation 7.45
|
2.8 Letter
Standard Deviation 9.7
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
Change at month 2 (n=98, 99)
|
5.8 Letter
Standard Deviation 8.54
|
5.1 Letter
Standard Deviation 9.72
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
Change at month 3 (n= 99, 99)
|
6.1 Letter
Standard Deviation 8.36
|
6.9 Letter
Standard Deviation 11.68
|
SECONDARY outcome
Timeframe: Baseline, month 1, month 2, month 3Population: FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area. Change from baseline calculated as observed post-baseline - baseline value.
Outcome measures
| Measure |
Ranibizumab
n=104 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
Change at month 1 (n= 101, 100)
|
-75.0 micrometers
Standard Deviation 91.04
|
-93.8 micrometers
Standard Deviation 106.43
|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
Change at month 2 (n= 100, 99)
|
-94.3 micrometers
Standard Deviation 103.41
|
-116.6 micrometers
Standard Deviation 123.35
|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
Change at month 3 (n= 100, 99)
|
-93.7 micrometers
Standard Deviation 110.41
|
-124.3 micrometers
Standard Deviation 122.46
|
SECONDARY outcome
Timeframe: Day 1 to day 85Population: Safety (SAF) analysis set: The SAF analysis set included all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.
The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).
Outcome measures
| Measure |
Ranibizumab
n=104 Participants
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 Participants
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
|---|---|---|
|
Number of Patients With Ocular and Systemic Adverse Events
TEAEs
|
32 Participants
|
32 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TESAEs
|
3 Participants
|
5 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TEAEs leading to death
|
0 Participants
|
0 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TEAEs with suspected relationship to study drug
|
6 Participants
|
4 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TESAEs with suspected relationship to study drug
|
1 Participants
|
0 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TEAEs w/ suspected relationship to ocular inject.
|
12 Participants
|
11 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TESAEs w/ suspected relationship to ocular inject.
|
1 Participants
|
0 Participants
|
|
Number of Patients With Ocular and Systemic Adverse Events
TEAEs leading to disc. of study treatment
|
3 Participants
|
1 Participants
|
Adverse Events
Ranibizumab
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Aflibercept
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Total
Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab
n=104 participants at risk
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 participants at risk
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Total
n=205 participants at risk
|
|---|---|---|---|
|
Eye disorders
Retinal haemorrhage
|
0.96%
1/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.98%
2/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Vitreous haemorrhage
|
0.96%
1/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.00%
0/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.49%
1/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.49%
1/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.96%
1/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.00%
0/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.49%
1/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.49%
1/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Nervous system disorders
Headache
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.49%
1/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.49%
1/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
Other adverse events
| Measure |
Ranibizumab
n=104 participants at risk
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Aflibercept
n=101 participants at risk
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
|
Total
n=205 participants at risk
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
7.7%
8/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
7.9%
8/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
7.8%
16/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Conjunctival hyperaemia
|
1.9%
2/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
1.5%
3/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Dry eye
|
2.9%
3/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
4/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Eye inflammation
|
1.9%
2/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.00%
0/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.98%
2/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Eye pain
|
3.8%
4/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
3.0%
3/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
3.4%
7/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Punctate keratitis
|
2.9%
3/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.4%
5/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Visual acuity reduced
|
1.9%
2/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
4/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Eye disorders
Vitreous floaters
|
1.9%
2/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
4/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
General disorders
Sensation of foreign body
|
2.9%
3/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.99%
1/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
4/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Infections and infestations
Nasopharyngitis
|
0.96%
1/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
1.5%
3/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Investigations
Blood pressure increased
|
1.9%
2/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
4/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.98%
2/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.98%
2/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Nervous system disorders
Headache
|
2.9%
3/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.00%
0/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
1.5%
3/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
2.0%
2/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.98%
2/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
2/104 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.00%
0/101 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
0.98%
2/205 • Throughout the study period (day 1 to day 85)
Safety assessments consisted of collecting all AEs, serious adverse events (SAEs), with their severity and relationship to study drug and ocular injection, and pregnancies.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER