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Elevatum was created as a phase 4, multicenter, open-label, single-arm trial to specifically study Vabysmo (faricimab-svoa) in these underrepresented populations.
Genentech has commenced the Elevatum trial of Vabysmo (faricimab-svoa) in patients diagnosed with diabetic macular edema (DME) who are part of underrepresented patient populations, the company announced Thursday.
As Black, African American, Hispanic, Latin American, and Indigenous people are disproportionately affected by diabetes, they have a higher risk of developing DME.
Elevatum (NCT05224102) was created as a phase 4, multicenter, open-label, single-arm trial to specifically study Vabysmo in these underrepresented populations.
The trial is intentionally designed to ease the barriers to clinical trial participation underrepresented racial and ethnic groups face by broadening eligibility criteria—which could inadvertently exclude patients from various racial groups—ensuring diverse clinical site leaders, and providing transportation and other resources and services to make trial participation easier for people, the company stated.
"Historically, ophthalmology clinical trials focused on diabetic eye disease have been lacking representation from different ethnic and racial groups," said Manuel Amador, MD, medical director at Genentech and study lead, in a statement. "By including a diversity of populations, perspectives and experiences, our goal is to improve scientific understanding of DME and ultimately improve the standard of care for all patients."
Vabysmo was approved by the FDA earlier this year for the treatment of DME and wet or neovascular age-related macular degeneration (AMD).
It is currently the only bispecific injectable eye medicine that is approved in the US for both wet AMD and DME, according to Genentech.
See more AMD and DME coverage