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Elevatum Phase 4 Trial Will Observe Faricimab in Underrepresented DME Populations

A new Phase 4 clinical trial from Genentech seeks to interpret the efficacy of its newest approved ophthalmic drug, faricimab (Vabysmo) for diabetic macular edema (DME) in patients from underrepresented populations

Elevatum Trial Recruits Black, African American, Hispanic, Latino, and Indigenous Patients with Leading Cause of Blindness to Evaluate Population-Based Clinical Efficacy and Safety of Intravitreal Bispecific Antibody Ang-2 and VEGF-A inhibitor faricimab, shortly after the drug’s approval for DME and neovascular age-related macular degeneration (nAMD) in January.

In an interview with HCP LiveElevatum researcher Matthew Cunningham, MD, of the Florida Retina Institute, discussed the importance of what he believes is the first industry-sponsored assessment to address the issue of representation in EMR trials.

“The whole rationale for this study is that while underrepresented populations are disproportionately affected by diabetes and at higher risk of developing EMD, there has always been a lack of diversity in ophthalmic clinical trials. “Cunningham said.

On the heels of faricimab’s historic approval this year – which made it the first in its new class of drugs approved for both DME and nAMD – Cunningham believes Elevatum is a necessary step to prove its worth absolute to patients with DME.

“In any clinical trial, the goal is to establish a new standard of care, potentially,” Cunningham said. “And the standard of care is great if there’s enough representation to say the results are transferable to all populations.”

Underrepresented patients typically present to Cunningham’s clinic with more advanced diabetic retinopathy and a greater risk of developing DME, he explained. In the absence of solid data for these patients, it is currently impossible to confirm whether agents such as faricimab are effective enough to compensate for these disparities.

“Who knows if we’re comparing apples to apples when comparing an underrepresented patient to a Caucasian or similar,” Cunningham said. “That’s why trials like this are important, because these issues really haven’t been addressed in the past.”

Cunningham also addressed the issue of recruiting the diverse patient population into clinical trials in ophthalmology, noting that there is often a need to “relieve the burden” that underrepresented patients face with the inclusion standards of ophthalmology. trials.

“Specific to ophthalmology and diabetes trials, hemoglobin A1c has been a really big deterrent,” he explained. “Many patients from underrepresented populations arrive with more advanced diabetic retinopathy. However, some of them arrive with a more strongly unregulated disease – their A1c can be 12-15%. The threshold for clinical trials could be 10%. So these numbers alone can sometimes rule them out. »