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Trial Outcomes & Findings for Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye (NCT NCT01661946)

NCT ID: NCT01661946

Last Updated: 2019-05-31

Results Overview

The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

1 month

Results posted on

2019-05-31

Participant Flow

Participant milestones

Participant milestones
Measure
Ranibizumab
intravitreal injection of 0.5mg ranibizumab in usual fashion Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Bevacizumab
intravitreal injection of 1.25mg bevacizumab in usual fashion Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
Overall Study
STARTED
5
5
Overall Study
COMPLETED
5
5
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bevacizumab
n=5 Participants
Ranibizumab
n=5 Participants
Total
n=10 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Age, Continuous
62.5 years
n=5 Participants
67.9 years
n=7 Participants
65.2 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of Enrollment
Canada
5 participants
n=5 Participants
5 participants
n=7 Participants
10 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 month

The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab.

Outcome measures

Outcome measures
Measure
Ranibizumab
n=5 Participants
intravitreal injection of 0.5mg ranibizumab in usual fashion Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Bevacizumab
n=5 Participants
intravitreal injection of 1.25mg bevacizumab in usual fashion Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
Maximum Concentration (Cmax) of Anti-VEGF Antibody
25.22 ng/mL
Standard Error 7.59
9.56 ng/mL
Standard Error 2.50

Adverse Events

Ranibizumab

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sanjay Sharma

Queen's University Department of Ophthalmology

Phone: 613-544-3400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place