Proliferative Diabetic Retinopathy (PDR) Clinical Trial
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
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.
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). ;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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Phase 2 | |
| Completed |
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Phase 2 | |
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Phase 1 |