ELEVATUM Study Confirms Vabysmo Efficacy Across Diverse Diabetic Macular Edema Patients

Key Insights

• The ELEVATUM study, a phase 4 trial, aimed to address the underrepresentation of minority groups in diabetic macular edema (DME) clinical trials.
• Results from ELEVATUM demonstrate that Vabysmo (faricimab) shows consistent efficacy in a diverse patient population, mirroring outcomes from the pivotal YOSEMITE and RHINE studies.
• The study enrolled a cohort enriched with African American, Hispanic, and American Indian/Pacific Islander participants, who are often diagnosed with more advanced DME.

The ELEVATUM study, an open-label, phase 4 trial, was designed to address the underrepresentation of Black, Hispanic, and other minority groups in ophthalmology clinical trials, particularly for diabetic macular edema (DME). Results presented at the American Academy of Ophthalmology (AAO) meeting in Chicago by Jeremiah Brown, M.D., of Retina Consultants of Texas, indicate that Vabysmo (faricimab) demonstrates consistent efficacy in a diverse patient population, aligning with findings from the pivotal phase 3 YOSEMITE and RHINE studies.

Addressing Underrepresentation in DME Trials

Underrepresentation in clinical trials is a significant issue, especially in DME, where minority groups often face delayed diagnoses and more advanced disease stages. The ELEVATUM study specifically aimed for a U.S. enrollment of 45% African American, 45% Hispanic, and 10% American Indian/Pacific Islander or Native Hawaiian participants. This targeted enrollment strategy sought to ensure that the study population reflected the real-world demographics of individuals affected by DME.

Consistent Efficacy with Vabysmo

All 124 ELEVATUM participants received Vabysmo for DME following the same regimen as in the YOSEMITE and RHINE trials: monthly injections for six months, followed by bimonthly injections for another six months. The results showed that Vabysmo's efficacy in this diverse cohort was consistent with the outcomes observed in the original phase 3 trials, suggesting that the treatment is effective across different racial and ethnic groups.

Comprehensive Data Collection

Beyond assessing visual acuity and retinal thickness, the ELEVATUM study is collecting extensive data on socioeconomic status, ZIP codes, education levels, body-mass index, and genetics. According to Dr. Brown, this comprehensive approach will create a "treasure trove of data" that can provide valuable insights into the complex interplay of factors influencing DME development and treatment outcomes in diverse populations. The study also allowed patients to self-identify their race as Black, Hispanic, or Native American.

Eligibility Criteria

The ELEVATUM study was conducted at sites that treat a high proportion of Black and Hispanic patients. Eligibility criteria allowed the inclusion of patients with diabetic macular edema who had a hemoglobin A1c level up to 12%.