NCT01661946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

August 2, 2012

Results QC Date

February 26, 2019

Last Update Submit

February 26, 2019

Conditions

Diabetic Macular Edema

Keywords

vascular endothelial growth factormacular edemadiabetic retinopathy

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

intravitreal injection of 0.5mg ranibizumab in usual fashion

Drug: Ranibizumab

Bevacizumab

ACTIVE COMPARATOR

intravitreal injection of 1.25mg bevacizumab in usual fashion

Drug: Bevacizumab

Interventions

BevacizumabDRUG

Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.

Also known as: Avastin
Bevacizumab
RanibizumabDRUG

Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use

Also known as: Lucentis
Ranibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Macular EdemaDiabetic Retinopathy

Interventions

BevacizumabRanibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Sanjay Sharma
Organization
Queen's University Department of Ophthalmology
sanjay_sharma60@hotmail.com
613-544-3400

Study Officials

  • Sanjay Sharma, MD MBA MSc FRCSC

    Department of Ophthalmology, Queen's University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 10, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

May 31, 2019

Results First Posted

May 31, 2019

Record last verified: 2019-02

Locations

CA(1)