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Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Bevacizumab
Ranibizumab
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Macular Edema focused on measuring vascular endothelial growth factor, macular edema, diabetic retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema
  • able to return for extra clinic visits according to study schedule

Exclusion Criteria:

  • active malignancy
  • previous retinal laser treatment
  • previous anti-VEGF therapy
  • previous vitrectomy

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ranibizumab

Bevacizumab

Arm Description

intravitreal injection of 0.5mg ranibizumab in usual fashion

intravitreal injection of 1.25mg bevacizumab in usual fashion

Outcomes

Primary Outcome Measures

Maximum Concentration (Cmax) of Anti-VEGF Antibody
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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2012
Last Updated
February 26, 2019
Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01661946
Brief Title
Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye
Official Title
Systemic Absorption of Bevacizumab and Ranibizumab in Humans Treated for Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x). In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
vascular endothelial growth factor, macular edema, diabetic retinopathy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
intravitreal injection of 0.5mg ranibizumab in usual fashion
Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
intravitreal injection of 1.25mg bevacizumab in usual fashion
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Primary Outcome Measure Information:
Title
Maximum Concentration (Cmax) of Anti-VEGF Antibody
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema able to return for extra clinic visits according to study schedule Exclusion Criteria: active malignancy previous retinal laser treatment previous anti-VEGF therapy previous vitrectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Sharma, MD MBA MSc FRCSC
Organizational Affiliation
Department of Ophthalmology, Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

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