Black, African American, Hispanic, Latin American and Indigenous people are disproportionately affected by diabetes and are at higher risk of developing diabetic macular edema (DME).
Recognizing this increased risk and the historical industry-wide lack of diversity in clinical trials, Genentech designed Elevatum (NCT05224102), a phase 4, multicenter, open-label, single-arm trial designed specifically to study Vabysmo in underrepresented populations. The first Elevatum patient was recently treated.
"Historically, ophthalmology clinical trials focused on diabetic eye disease have been lacking representation from different ethnic and racial groups," Manuel Amador, MD, medical director at Genentech who is helping lead the study, said in a company news release. "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."
The Elevatum study was developed in collaboration with ophthalmologists and an endocrinologist from diverse backgrounds as well as patient advocacy groups. It is intentionally designed to ease the barriers to clinical trial participation faced by underrepresented racial and ethnic groups.
That includes 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 overall goal of the study is to better understand how these traditionally underrepresented patient populations with DME respond to treatment in order to help deliver better, more equitable care.
Vabysmo is also the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from 1 to 4 months apart in the first year after four initial monthly doses, based on patient anatomy and vision outcomes.