MELISSA LI, JOCELYN HE, BRIAN L. VANDERBEEK, GUI-SHUANG YING
{"title":"Racial and Ethnic Disparities at Enrollment in DRCRnet Clinical Trials for Diabetic Macular Edema","authors":"MELISSA LI, JOCELYN HE, BRIAN L. VANDERBEEK, GUI-SHUANG YING","doi":"10.1016/j.ajo.2025.02.029","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>To assess racial/ethnic disparities and association with diabetic macular edema (DME) characteristics at enrollment in DRCR Retina Network (DRCRnet) DME clinical trials.</div></div><div><h3>Design</h3><div>Retrospective, cross-sectional analysis of data from DRCRnet clinical trials.</div></div><div><h3>Subjects</h3><div>5468 participants in 17 DRCRnet DME trials (2003-2020).</div></div><div><h3>Methods</h3><div>The racial and ethnic distribution of DRCRnet DME trial participants was compared to United States census data and DME prevalence data in the CDC's Vision and Eye Health Surveillance System (VEHSS). Generalized linear models were used for comparing demographics, HgbA1c, diabetic retinopathy (DR) severity, and visual acuity (VA) among racial/ethnic groups, and for determining factors associated with VA.</div></div><div><h3>Main Outcome Measures</h3><div>Racial and ethnic distribution of DME trial participants; patient and ocular characteristics at enrollment.</div></div><div><h3>Results</h3><div>Compared to VEHSS (64% White, 16% Black, 4% Asian, 14% Hispanic) and the 2020 U.S. census (62% White, 12% Black, 6% Asian, 19% Hispanic), White (76%) participants were over-represented, and Asians (2%) and Hispanics (12%) were under-represented (<em>P</em> < .001) in DME trials. HgbA1c was higher in Black and Hispanic (8.3) than in White (7.7) and Asian (7.6) participants (<em>P</em> < .001). More Asian (20%) and Hispanic (23%) participants had proliferative DR than White (19%) and Black (15%) participants (<em>P</em> < .001). Hispanic ethnicity, female gender, older age at diabetes diagnosis, and severe DR were independently associated with worse VA (all <em>P</em> < .05).</div></div><div><h3>Conclusions</h3><div>Hispanic participants, while under-represented, had higher HgbA1c, more severe DR, and worse VA than other groups, emphasizing the need for diverse recruitment in DME trials.</div></div>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":"273 ","pages":"Pages 231-239"},"PeriodicalIF":4.1000,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002939425000959","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose
To assess racial/ethnic disparities and association with diabetic macular edema (DME) characteristics at enrollment in DRCR Retina Network (DRCRnet) DME clinical trials.
Design
Retrospective, cross-sectional analysis of data from DRCRnet clinical trials.
Subjects
5468 participants in 17 DRCRnet DME trials (2003-2020).
Methods
The racial and ethnic distribution of DRCRnet DME trial participants was compared to United States census data and DME prevalence data in the CDC's Vision and Eye Health Surveillance System (VEHSS). Generalized linear models were used for comparing demographics, HgbA1c, diabetic retinopathy (DR) severity, and visual acuity (VA) among racial/ethnic groups, and for determining factors associated with VA.
Main Outcome Measures
Racial and ethnic distribution of DME trial participants; patient and ocular characteristics at enrollment.
Results
Compared to VEHSS (64% White, 16% Black, 4% Asian, 14% Hispanic) and the 2020 U.S. census (62% White, 12% Black, 6% Asian, 19% Hispanic), White (76%) participants were over-represented, and Asians (2%) and Hispanics (12%) were under-represented (P < .001) in DME trials. HgbA1c was higher in Black and Hispanic (8.3) than in White (7.7) and Asian (7.6) participants (P < .001). More Asian (20%) and Hispanic (23%) participants had proliferative DR than White (19%) and Black (15%) participants (P < .001). Hispanic ethnicity, female gender, older age at diabetes diagnosis, and severe DR were independently associated with worse VA (all P < .05).
Conclusions
Hispanic participants, while under-represented, had higher HgbA1c, more severe DR, and worse VA than other groups, emphasizing the need for diverse recruitment in DME trials.
期刊介绍:
The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect.
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