Image source: Duke University School of Medicine
Hemoglobin A1C standard is < Proposition 10 places more restrictions on treatment eligibility for black patients with diabetic macular edema than for white patients, a new study shows.
This study sought to understand how inclusion and exclusion criteria limiting clinical trial inclusion of participants with diabetic macular edema affects race-based clinical trial eligibility. For example, one standard requires an HbA1c level of 10 or less.
Durga Borkar, MD, MMCi, of the Duke Eye Center at Duke University School of Medicine, presented the study at the 127th Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco, California. In an interview with HCPLive, Boca talked about his team’s findings.
“We know that increasing diversity in clinical trials continues to be a goal in ophthalmology, particularly in areas where chronic diseases such as diabetes and glaucoma are evaluated,” Boca said. “This study shows that one of the ways we can increase diversity in clinical trials is to take a closer look at our inclusion and exclusion criteria and the different effects they may have on certain populations, and to do this step before a clinical trial even begins.” . “
Researchers identified participants in the Optum database who were newly diagnosed with diabetic macular edema between January 1, 2022, and June 30, 2022. Participants were eligible if they had been “continuously enrolled” for less than 2 years before the index date (n = 215,457), had previously received anti-VEGF therapy or topical laser therapy (n = 54,348), or had a medical condition that could be confused with diabetic macular edema. (e.g. retinal occlusion) (n = 41,260), and no race recorded (n = 741). This criterion excluded 350,314 individuals, and 12,782 individuals ultimately participated in the study.
From there, the researchers looked at the racial breakdown and found a large number of white participants. Among eligible participants, 6864 were white, 2327 were black, 2904 were Hispanic, and 688 were Asian.
According to Borkar, the A1C level required for stage 3 diabetic maculopathy is < 12 or <10. After checking A1C standards < With 10 people of each race, investigators found that 87.8% were white (n = 6024) (P < .001), 81.9% were black (n = 1906) (P < .001), and 82.4% were Hispanic (n = 2393) (P < .001), 90.4% Asian (n = 622) (P = .04).
In a poster abstract for the study, Boca and colleagues wrote that they likely underestimated the impact of inclusion and exclusion criteria related to disease control because the study focused only on insured patients. All participants gained confidence since the researchers retrieved data from the Optum database. Borkar speculated that if the team had looked at a larger database that included uninsured patients, limiting patients’ A1C criteria might have had a larger impact.
Additionally, Boca discussed the lack of access for minority groups, particularly African Americans, to participate in clinical trials. Previous geographical studies, such as examining the retina, have explored this topic. For future research, Boca believes it will be important to examine the impact of each standard on eligible populations, and to examine the impact in terms of race and socioeconomic status, without excluding any racial or ethnic group.
“I think the eligibility criteria are just one piece of the puzzle — there could be a lot of factors at play,” Boca said. “I think there are historical and cultural factors that influence patients’ willingness to participate in trials, and these need to be evaluated and addressed.”
refer to
Bokar, Durga. Understanding the impact of HbA1c thresholds on race-based DME clinical trial eligibility. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3-6, 2023.