Comparison of Changes of Inflammatory Proteins in Aqueous Humour of Subjects Treated With Avastin vs Lucentis
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Proliferative Diabetic Retinopathy (PDR)
Intervention: Injection of Avastin / Lucentis, sampling aqueous humour (Other)
Phase: N/A
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Farzin Forooghian, MD FRCSC, Principal Investigator, Affiliation: Clinical Assistant Professor
Summary
PDR is a leading cause of irreversible vision loss in North America. This disease is caused
by the growth of abnormal blood vessels in the retina. These abnormal blood vessels can
bleed inside the eye, causing a vitreous hemorrhage (VH). Sometimes when patients have this
bleeding, a surgery called vitrectomy is required to remove the blood from within the eye.
In order to reduce complications during the surgery, most retina surgeons will inject
Avastin into the eye a few days before the surgery.
Avastin (bevacizumab) is currently not approved by Health Canada to treat any ocular
disease. Lucentis (ranibizumab) is approved by Health Canada as a treatment for age-related
macular degeneration, diabetic macular edema, and retinal venous occlusive disease. While
Avastin is not approved by Health Canada for the treatment of these diseases, the majority
of retina specialists around the world are now using Avastin "off-label" to treat these
diseases. That is because Avastin and Lucentis both tend to work equally well in these
disease, but Avastin is significantly cheaper. While Avastin and Lucentis are generally
regarded to be equal, there may be some differences between these two drugs that have not
been discovered. The aim of this study is to look for these differences.
Previous research by the investigators in this study has shown that injecting Avastin into
eyes causes increased inflammatory proteins to develop inside the eye. This increase in
these proteins was related to complications that developed after the vitrectomy surgery.
Lucentis may be associated with less of an increase in inflammatory proteins (and less
complications). The aim of this study will be to compare Avastin and Lucentis with respect
to how they affect inflammatory proteins in the eye, as well as the rate of complications
during surgery.
Study participants will be divided into two arms ("groups") of 30 subjects. Subjects will
receive Avastin or Lucentis a few days before vitrectomy surgery. The assignment will be
random and the study is double-masked. Masking is done so that the investigators can
clearly determine any differences between the 2 drugs.
Clinical Details
Official title: A Randomized, Multi-Centre, Double-Masked, Study to Compare Inflammatory Protein Changes in Aqueous Humour of Subjects Treated With Bevacizumab (Avastin) vs Ranibizumab (Lucentis) Pre-Vitrectomy for Proliferative Diabetic Retinopathy
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: The primary outcome will be the change in global levels of intraocular inflammatory cytokines in the aqueous humour of patients with Proliferative Diabetic Retinopathy.
Secondary outcome: Secondary outcomes include the change in angiogenic cytokine levels.Secondary outcome measure considers intraoperative complications during vitrectomy.
Detailed description:
60 subjects will take part in this study at 2 sites in Canada: Vancouver (Eye Care Centre,
Vancouver General Hospital, and Mount Saint Joseph Hospital) and Toronto (Sunnybrook Health
Sciences Centre).
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. PDR and vitreous hemorrhage scheduled for vitrectomy surgery and bevacizumab
pre-treatment.
Exclusion criteria:
1. Vitreous hemorrhage from other causes such as central retinal vein occlusion or
ocular ischemic syndrome.
2. Pregnant or breastfeeding women.
3. Less than 19 years of age.
Locations and Contacts
UBC/VGH Eye Care Centre, Vancouver, British Columbia V5Z3N9, Canada
Additional Information
Starting date: July 2012
Last updated: April 15, 2015
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