McMaster professor of surgery leads major trial for critical vision treatment

McMaster University professor of surgery Varun Chaudhary is leading a major international, multi-center trial investigating a potential new treatment regimen for diabetic macular edema (DME) using Vabsymo (faricimab), a medication already approved for use in Canada.

The International Study to Investigate Treat and Extend in DME (INSITE-DME) trial will investigate the effectiveness of a personalized Vabsymo treatment routine, using eye exams to individualize care and potentially extend the interval between injections of the anti-vascular endothelial growth factor (anti-VEGF) and anti-Ang2 medication.

DME happens when blood vessels leak into a part of the retina called the macula, causing it to swell, which can lead to blindness. The current standard of care is anti-VEGF injections into the eye to reduce leakage. Chaudhary said the current treatment regimen is difficult for patients and health-care systems alike.

“Given that there is no consensus on the best treatment algorithm to monitor and treat patients with DME, one important goal of this trial will be to standardize treatment and reduce variability in how patients are managed around the world,” said Chaudhary, the study’s principal investigator and chief of ophthalmology at St. Joseph’s Healthcare Hamilton.

Diabetes affects 463 million individuals globally and is projected to reach 700 million individuals by 2045. More than 23 million patients with diabetes will develop DME, a leading cause of vision loss in patients with the condition.

“There is a robust body of evidence that demonstrates that a high number of clinic visits is unsustainable, leads to high treatment discontinuation rates for patients and ultimately results in suboptimal vision gains and negatively impacts patients’ quality of life,” said Chaudhary.

The INSITE-DME study is expected to last 2 years and will recruit roughly 450 participants across 45 sites in Canada, the United States, Australia and the United Kingdom. INSITE-DME will also establish a retina-focused image reading center and databank at McMaster that can further be leveraged in future retina trials.

“The goal is to significantly enhance the patient journey of those living with diabetic macular edema by allowing them to achieve and maintain maximal vision while greatly reducing the treatment and monitoring burden,” said Peter K Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research and professor of ophthalmology, Cleveland Clinic Lerner College of Medicine and Cole Eye Institute, Cleveland, OH.

The INSITE-DME trial is being conducted within the Department of Surgery Clinical Trial Unit (CTU) at McMaster. Leveraging its historic reputation in clinical trials, data management at the Ontario Clinical Oncology Group, and image evaluation, the CTU is broadening their breadth and depth of expertise by expanding into retina research, with an ultimate vision to be a world leader in retina trials. Chaudhary and the CTU are also establishing a retina trials investigators network, with a global focus on building future trials in retinal diseases.

The collaboration between F. Hoffmann-La Roche Ltd and the CTU is bringing together the expertise of both the pharmaceutical industry and academia to generate research that can enhance patient care for retinal diseases.

“The design and execution of practice-changing trials in surgery is fundamental to advancement. The INSITE-DME program brings together exceptional leaders and critical collaborations within and outside McMaster University to provide sight-saving evidence to patients worldwide,” said Mohit Bhandari, distinguished university professor, CTU lead and chair of the Department of Surgery.

Paul O’Byrne, dean and vice-president of the Faculty of Health Sciences, said that “The research being spearheaded by Dr. Chaudhary’s team has the potential to make a huge difference for millions of people with diabetes who are in danger of losing their sight.”

“It is thanks to visionary leaders like Dr. Chaudhary that McMaster University remains a global hub for health sciences innovation that continues to transform lives around the world.”

This is an investigator-initiated trial with Chaudhary as principal investigator, McMaster University as sponsor and funding from F. Hoffmann-La Roche Ltd.

Learn more about Varun Chaudhary on his McMaster Experts profile.