A recent Phase IV clinical trial named ELEVATUM has shown promising results for Vabysmo, a medication used to treat diabetic macular edema (DME). The study focused on racial and ethnic groups often underrepresented in clinical research, including Black and Hispanic individuals. These groups are disproportionately affected by diabetes and DME, a leading cause of vision loss.
The study, conducted in the United States, involved 124 participants and demonstrated that Vabysmo, administered every eight weeks for a year, significantly improved vision. On average, participants could read an additional 12.3 letters on an eye chart, approximately two and a half lines. Notably, Hispanic and Latino participants who started with the most severe DME experienced an average vision gain of almost three lines on an eye chart. African American participants also demonstrated substantial improvement. Importantly, Vabysmo was well-tolerated, with no new safety concerns identified.
This study, a pioneering effort in retina research for historically underrepresented populations, confirms the effectiveness of Vabysmo as a first-line treatment for DME across diverse ethnic and racial groups. The findings are consistent with previous Phase III studies (YOSEMITE and RHINE) and further demonstrate the drug’s ability to reduce fluid buildup in the retina, a key indicator of treatment efficacy.
The ELEVATUM study is significant for its positive results and its focus on addressing health disparities in clinical trials. The study was intentionally designed to promote enrollment and retention of underrepresented patients. This included conducting the trial at sites treating a high proportion of these populations, incorporating broader eligibility criteria, and addressing factors like higher HbA1c levels, which can inadvertently exclude certain ethnic and racial groups from diabetes trials.
Genentech, the company behind Vabysmo, emphasizes its commitment to inclusive research and equitable healthcare. The ELEVATUM study embodies this commitment, providing valuable data on treatment efficacy in diverse populations and setting a precedent for designing future clinical trials that are more representative and inclusive.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
