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The following is a summary of “Racial and Ethnic Disparities at Enrollment in DRCRnet Clinical Trials for Diabetic Macular Edema,” published in the February 2025 issue of American Journal of Ophthalmology by Li et al.
Researchers conducted a retrospective study to evaluate racial and ethnic disparities and association with diabetic macular edema (DME) characteristics at enrollment in DRCR Retina Network (DRCRnet) DME clinical trials.
They analyzed 5,468 participants from 17 DRCRnet DME trials conducted between 2003 and 2020. The racial and ethnic distribution of trial participants was compared to United States Census data and DME prevalence estimates from the CDC Vision and Eye Health Surveillance System (VEHSS). Generalized linear models were applied to compare demographics, HgbA1c levels, diabetic retinopathy (DR) severity, and visual acuity (VA) across racial and ethnic groups. Additionally, these models were used to identify factors associated with VA.
The results showed that racial and ethnic representation in DME trials differed significantly from national data. Compared to VEHSS data (64% White, 16% Black, 4% Asian, 14% Hispanic) and the 2020 United States Census (62% White, 12% Black, 6% Asian, 19% Hispanic), White participants (76%) were overrepresented, while Asian (2%) and Hispanic (12%) participants were underrepresented (P <0.001) in DME trials. The HgbA1c levels were higher in Black and Hispanic participants (8.3) compared to White (7.7) and Asian (7.6) participants (P <0.001). The prevalence of proliferative DR was greater in Asian (20%) and Hispanic (23%) participants compared to White (19%) and Black (15%) participants (P <0.001). Worse VA was independently associated with Hispanic ethnicity, female gender, older age at diabetes diagnosis, and severe DR (all P <0.05).
Investigators concluded that Hispanic participants, despite being underrepresented, demonstrated higher HgbA1c, more severe DR, and worse VA, highlighting the necessity for increased diversity in DME trials.