Trial Outcomes & Findings for Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF (NCT NCT02118831)
NCT ID: NCT02118831
Last Updated: 2016-05-19
Results Overview
Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2016-05-19
Participant Flow
patients were recruited at a single private medical clinic between May of 2012 through October 2013
Participant milestones
| Measure |
Aflibercept
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care.
|
Bevacizumab
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care.
|
Ranibizumab
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
15
|
20
|
|
Overall Study
COMPLETED
|
21
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
Baseline characteristics by cohort
| Measure |
Aflibercept
n=21 Participants
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care.
|
Bevacizumab
n=15 Participants
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care.
|
Ranibizumab
n=20 Participants
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 4 • n=5 Participants
|
75 years
STANDARD_DEVIATION 3 • n=7 Participants
|
77 years
STANDARD_DEVIATION 5 • n=5 Participants
|
76 years
STANDARD_DEVIATION 4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
20 participants
n=5 Participants
|
56 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsMaximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
Outcome measures
| Measure |
Aflibercept
n=21 Participants
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care.
|
Bevacizumab
n=15 Participants
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care.
|
Ranibizumab
n=20 Participants
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care.
|
|---|---|---|---|
|
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
After 3rd dose
|
0.58 nM
Standard Deviation 0.52
|
1.47 nM
Standard Deviation 0.55
|
0.07 nM
Standard Deviation 0.05
|
|
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
After 1st dose
|
0.45 nM
Standard Deviation 0.29
|
0.76 nM
Standard Deviation 0.31
|
0.11 nM
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: baseline and month 4Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).
Outcome measures
| Measure |
Aflibercept
n=21 Participants
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care.
|
Bevacizumab
n=15 Participants
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care.
|
Ranibizumab
n=20 Participants
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care.
|
|---|---|---|---|
|
Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
Baseline
|
19.2 pg/mL
Interval 15.3 to 23.1
|
22.5 pg/mL
Interval 17.3 to 27.6
|
17.0 pg/mL
Interval 11.6 to 22.5
|
|
Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
Month 4
|
11.3 pg/mL
Interval 8.5 to 14.2
|
10.6 pg/mL
Interval 6.9 to 14.1
|
17.0 pg/mL
Interval 13.2 to 21.7
|
Adverse Events
Aflibercept
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bevacizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place