ELEVATUM Study's Reason to Be: Underrepresentation in Clinical Trials | AAO 2024

Black, Hispanic and member of other groups are underrepresented in ophthalmology and other clinical trials. Moreover, when it comes diabetic retinopathy, members of those groups often get a diagnosed when the disease is more advanced and possibly harder to remedy.

The open-label, phase 4 ELEVATUM study of Vabysmo (faricimab) was designed to address those problems, Jeremiah Brown, M.D., of Retina Consultants of Texas, one of the study’s lead investigators, explained in this interview with Managed Healthcare Executive that was recorded before the American Academy of Ophthalmology’s annual meeting in Chicago. Brown presented results from the ELEVATUM yesterday that showed results among its 124 participants were consistent with those from the pivotal phase 3 YOSEMITE and RHINE studies of Vabysmo.

Brown said the enrollment goals of the U.S. part of the Genentech-funded ELEVATUM study were 45% African American participants, 45% Hispanic participants and 10% American Indian Pacific Islander or native Hawaiian participants. All the ELEVATUM participants were treated with Vabysmo for diabetic macular edema in the same way that the patients enrolled in the YOSEMITE and RHINE trial were: monthly injections for six months followed by injections every other month for another six months.