Although Black, Asian, and Hispanic patients remain underrepresented in clinical trials for diabetic macular edema (DME), a 20-year review of racial reporting and distribution trends among DME studies suggests that this disparity is lessening.
Study Design
This cross-sectional retrospective study examined DME clinical trials conducted in the United States from 2002 to 2021 in comparison to US census data. The goal was to uncover trends in racial reporting and ethnic distribution of enrolled participants over time.
Outcomes
Race reporting and minority patient enrollment in DME clinical trials has improved over the past 20 years. From 2002 to 2021, the proportion of Asian patients enrolled in DME trials increased from 2.4% to 8.0%, and the proportion of Hispanic patients increased from 13.4% to 19.5%. However, Black, Asian, and Hispanic patients remain markedly underrepresented within DME clinical trials when compared to the prevalence of diabetes among these minority populations.
Limitations
No significant limitations.
Clinical Significance
Diabetic macular edema is not only the leading cause of vision loss among patients with diabetes, but it also disproportionately affects Black and Hispanic patients.1 As clinical trials continue to find better methods to treat DME, it is important that pertinent patient populations—including patients of Hispanic, Black, and Asian race/ethnicity—are enrolled in greater numbers to adequately represent the proportion of these individuals with DME in the general population. The trend toward more accurate racial and ethnic distribution over the past 20 years is reassuring to see and will hopefully continue to improve over the next 20 years.
Financial Disclosures: Dr. Courtney Crawford discloses financial relationships with Genentech, Regeneron Pharmaceuticals (Consultant/Advisor, Lecture Fees/Speakers Bureau); Alcon Laboratories, Allergan, DORC International (Dutch Ophthalmic), Ocular Therapeutix, Oculus Surgical (Consultant/Advisor); Apellis, Iveric Bio (Lecture Fees/Speakers Bureau); Intelligent Retinal Imaging Systems, Topcon Medical Systems, Welch Allyn (Independent Contractor).
Reference:
1 Zhang et al. American Journal of Ophthalmology. 2012;154:S53-S62.e1.