One of the leading causes of blindness in the United States, diabetic macular edema (DME) still goes undiagnosed in its early stages more often than not. By the time symptoms do appear and progress, this insidious condition caused by high blood sugar may have stolen a person’s sight.

Because diabetes affects Black, Hispanic, Latinx and Indigenous people disproportionately, the impact of this diabetic eye disease among patients from these backgrounds is unequal as well.

To help address these significant racial and ethnic disparities, Genentech developed and launched the Elevatum clinical trial, the first company-sponsored retinal study of its kind. The trial was designed specifically to study DME in underrepresented populations.

Manuel Amador, M.D., a clinical epidemiologist, retina specialist and medical director in Genentech’s US Medical Affairs who helps lead Elevatum, has devoted his career to understanding and overcoming healthcare inequities. “Our goals with this trial are to improve scientific understanding of DME, broaden our understanding of the patient groups disproportionately affected by this disease and ultimately improve the standard of care for all patients,” Dr. Amador explained.

The Phase IV study began enrolling patients in early 2022 and includes patients who identify as Black, African American, Hispanic, LatinX, Native American, Alaska Native, Native Hawaiian or Pacific Islander.

“Over my career, I’ve witnessed the disproportionate impact of diabetic eye disease, including DME, on Black and brown patients. At the same time, we’ve had a long-standing lack of diversity in clinical trials,” said Joseph Coney, M.D., a retina specialist in Cleveland and lead investigator of the Elevatum trial. “As a Black ophthalmologist, it’s deeply meaningful for me to participate in a trial that’s focused on communities of color in a way that no other trial has in ophthalmology. And my hope is it opens the door for others to follow suit.”

Addressing Unintended Barriers

We developed Elevatum using best practices from two of our other groundbreaking trials: the EMPACTA trial for patients with COVID-19 pneumonia and the CHIMES trial in multiple sclerosis. The Elevatum study team sought to address factors that could hinder trial enrollment among underrepresented patients with diabetes. As Dr. Amador explained, “As we talked to more and more patients living with diabetes and doctors who treat them, we saw it would be critical to address unintended barriers to participation so that more people could take part.”

For example, retina clinical trials often have rigid inclusion criteria that have historically disqualified many patients with more severe forms of DME when their condition is first diagnosed – a group that disproportionately includes members of underrepresented racial and ethnic groups. Expanding inclusion criteria opened the trial to more patients so it better reflects the real world.

Transportation to clinical trial sites also poses a significant barrier for some people with DME. A patient with low vision may not be able to drive to the clinic to keep their study appointment, for example, or they may be unable to navigate other means of transportation. To mitigate these challenges, the study team built a transportation option into the study design, arranging for transportation at no cost to patients.

They also embraced what seems like a simple idea: serve the patients where they live.

“A critical step in our efforts to advance inclusive research involves broadening our network of clinical trial sites, investigators and vendors who serve diverse patient populations,” said Matthew Meldorf, M.D., executive director of Ophthalmology for U.S. Medical Affairs. For example, in order to increase inclusion of Native American patients in Elevatum, we identified and worked with trial sites near Native American reservations to reach these patients in their communities.”

Setting the Stage for Future Inclusion

Looking ahead, Elevatum sets the stage for developing more inclusive trials overall, and reinforces the company’s commitment to diversity and inclusion.

“Elevatum represents our continued drive to build inclusive research capabilities, in this instance tackling underrepresentation in the ophthalmology arena,” said Jamie Freedman, senior vice president and head of U.S. medical affairs at Genentech. “Through this trial, we are one step closer to our long-term goal of ensuring that all our studies include often underrepresented racial and ethnic populations, to help advance treatment for all.”