Trial Outcomes & Findings for Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration (NCT NCT02507388)
NCT ID: NCT02507388
Last Updated: 2018-07-02
Results Overview
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 5 study centers in Japan and 2 study centers in the United States.
This reporting group includes all subjects who signed an informed consent form and were assigned an identification number (51), minus one subject exited as a screen failure prior to treatment initiation.
Participant milestones
| Measure |
Brolucizumab 3 mg
Brolucizumab 3 milligrams (mg)/50 microliters (μL) administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Brolucizumab 3 mg
n=25 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 8.53 • n=99 Participants
|
73.6 years
STANDARD_DEVIATION 7.09 • n=107 Participants
|
72.4 years
STANDARD_DEVIATION 7.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ancestry
Japanese
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ancestry
Non-Japanese
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Primary Diagnosis of Neovascular Age-Related Macular Degeneration
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Pre-dose Anti-Drug Antibody (ADA) Status
Negative
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Pre-dose Anti-Drug Antibody (ADA) Status
Positive
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hrPopulation: The PK analysis set included all subjects who received an intravitreal (IVT) injection with evaluable PK data and with no major protocol deviations that could have had an impact on the PK analysis.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=25 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Maximum Analyte Serum Concentration [Cmax (ng/mL)]
|
20.7 ng/mL
Standard Deviation 29.4
|
77.6 ng/mL
Standard Deviation 105
|
PRIMARY outcome
Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hrPopulation: PK analysis set
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=25 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]
|
20.3 hours
Standard Deviation 24.6
|
17.4 hours
Standard Deviation 14.7
|
PRIMARY outcome
Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hrPopulation: PK analysis set
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=25 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]
|
2480 ng*h/mL
Standard Deviation 5470
|
9160 ng*h/mL
Standard Deviation 12300
|
PRIMARY outcome
Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hrPopulation: PK analysis set
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=17 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=24 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]
|
3380 ng*h/mL
Standard Deviation 6860
|
9770 ng*h/mL
Standard Deviation 12600
|
PRIMARY outcome
Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hrPopulation: PK analysis set. Harmonic mean and jackknife estimate of the standard deviation are presented.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=18 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=24 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Elimination Half-life in Serum [t1/2 (h)]
|
108 hours
Standard Deviation 40.7
|
103 hours
Standard Deviation 52.5
|
PRIMARY outcome
Timeframe: Day 1Population: PK analysis set
Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=24 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]
|
13.5 ng/mL
Standard Deviation 20.0
|
65.7 ng/mL
Standard Deviation 107
|
PRIMARY outcome
Timeframe: Day 57Population: PK analysis set
Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=22 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)]
|
12.4 ng/mL
Standard Deviation 21.8
|
45.0 ng/mL
Standard Deviation 59.9
|
SECONDARY outcome
Timeframe: Day 0 (predose), Day 28, Day 84Population: PK analysis set
A positive ADA status is defined as induced ADA status with ADA negative at predose and with a post-dose titer value increase of 2 or more dilutions at any time point or boosted ADA status with ADA positive at predose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=25 Participants
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
Brolucizumab 6 mg
n=25 Participants
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
|
|---|---|---|
|
Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test)
|
16.0 percentage of participants
|
4.0 percentage of participants
|
Adverse Events
Pre-Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Brolucizumab 3 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Brolucizumab 6 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Treatment
n=50 participants at risk
All subjects who signed an informed consent form and were assigned an identification number (51), minus one subject exited as a screen failure prior to treatment initiation
|
Brolucizumab 3 mg
n=25 participants at risk
All subjects who received an IVT injection of brolucizumab 3 mg
|
Brolucizumab 6 mg
n=25 participants at risk
All subjects who received an IVT injection of brolucizumab 6 mg
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
Other adverse events
| Measure |
Pre-Treatment
n=50 participants at risk
All subjects who signed an informed consent form and were assigned an identification number (51), minus one subject exited as a screen failure prior to treatment initiation
|
Brolucizumab 3 mg
n=25 participants at risk
All subjects who received an IVT injection of brolucizumab 3 mg
|
Brolucizumab 6 mg
n=25 participants at risk
All subjects who received an IVT injection of brolucizumab 6 mg
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
32.0%
8/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
32.0%
8/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Eye pain
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Retinal haemorrhage
|
4.0%
2/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Vitreal cells
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
16.0%
4/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
12.0%
3/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 105 days). AEs are reported as pre-treatment and treatment-emergent.
An adverse event was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
Additional Information
Global Program Clinical Head, Ophthalmology
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER