Symptoms begin without warning, and it’s all too easy to ignore them until it’s too late: blurry eyesight, subtle color dimming, or tiny black dots that seem to “float” across one’s field of vision. These are just a few of the signs of diabetic macular edema (DME), a condition that affects nearly 750,000 people in the United States alone — a number that is expected to grow as the prevalence of diabetes increases.
DME is a leading cause of vision loss among working-age adults, and it can have a devastating impact on those with the condition, their families, and their caregivers.
Even worse, DME disproportionately affects different groups of people, just like diabetes does. Blacks, Hispanics, Latinos/Latin Americans, and Indigenous peoples are at greater risk of developing DME. In the United States for example, non-Hispanic adults are three times more likely to develop DME than non-Hispanic white adults. By the time the retina specialist sees people from underrepresented groups, their condition has often progressed to a more advanced stage.
Recognizing this increased risk, Genentech launched a global clinical trial specifically for underrepresented patient groups with DME, including people who identify as Black, African American, Hispanic, Hispanic/Latin American, Native American, Alaskan Native, or Native Hawaiian or Pacific Islander. The Phase IV trial of ELEVATUM was developed in collaboration with ophthalmologists and endocrinologists from diverse backgrounds as well as patient advocacy organizations. This study builds on other comprehensive trials developed by Genentech for affected patients COVID-19 And the multiple sclerosisIt is intentionally designed to facilitate Barriers to participation in clinical trials faced by underrepresented racial and ethnic groups.
For example, ways to reduce patient financial burden and increase participation include patient reimbursement, patient stipend, free door-to-door transportation, reimbursement for hotel and meal costs, and a portal that provides a single central location that patients can connect to to request trial-related questions. For visually impaired or visually impaired participants, we provide verbal and electronic informed consent materials with audio playback capabilities.
Our goal is to understand how groups of patients with conventional underrepresentation with DME respond to treatment with new ophthalmology, the first of its kind in order to derive insights that will help us deliver better and more equitable care and design better clinical trials in the future. We also hope that this work will yield guidelines and best practices that can be applied in research in other disease areas.
Inclusion and diversity are an integral part For innovation and fair care. Within Genentech, we have built and nurtured a highly collaborative culture based on diverse perspectives and experiences. In terms of trial design, we believe it is necessary to establish more inclusive eligibility criteria, ensure greater diversity among clinical site leaders, and provide resources and services to facilitate people’s participation. Ultimately, a more holistic approach to deepening our collective understanding of conditions across racial and ethnic groups will help develop more effective and personalized treatments, improve standards of care, and help achieve equitable care for all.