June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Racial and Gender Disparities in Enrollment and Participation in Diabetic Macular Edema Clinical Trials in the United States
Author Affiliations & Notes
  • Ajay E. Kuriyan
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Theo Bowe
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Rebecca Russ Soares
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Charles Huang
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Rishi P Singh
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • M. Ali Ali Khan
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Basil K Williams
    Cincinnati Eye Institute, Cincinnati, Ohio, United States
  • Jayanth Sridhar
    University of Miami Health System Bascom Palmer Eye Institute, Miami, Florida, United States
  • Allen Chiang
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Michael Cohen
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Michael Klufas
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Omesh P Gupta
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Yoshihiro Yonekawa
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • David Xu
    Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Footnotes
    Commercial Relationships   Ajay Kuriyan Allergan, Alimera Sciences, Bausch+Lomb, Genentech, Novartis, Recens Medical, Optos, Spark Therapeutics, Code C (Consultant/Contractor), Recent Medical, Code O (Owner), Annexon, Genentech, Adverum, Code R (Recipient); Theo Bowe None; Rebecca Soares None; Charles Huang None; Rishi Singh Regeneron, Alcon, Genentech, Bausch, Novartis, Gyroscope, Asclepix, Zeiss. , Code C (Consultant/Contractor), Apellis, NGM Biopharm, Code R (Recipient); M. Ali Khan Allergan, Apellis, Genentech, Code C (Consultant/Contractor), Regeneron, Code R (Recipient); Basil Williams Allergan, Castle Biosciences, Genentech, Code C (Consultant/Contractor); Jayanth Sridhar Alcon, Genentech, Dorc, Regeneron, Allergan, Code C (Consultant/Contractor); Allen Chiang Genentech, Apellis, Gyroscope, Code C (Consultant/Contractor), Regeneron, Genentech, Apellis;, Code R (Recipient); Michael Cohen Allergan, Keeler, Alimera Sciences, Code C (Consultant/Contractor); Michael Klufas Genentech, Regeneron; Consultant: Allergan, RegenexBio, Code C (Consultant/Contractor); Omesh Gupta Alcon, Code C (Consultant/Contractor); Yoshihiro Yonekawa Alcon, Alimera, Allergan, Genentech, Code C (Consultant/Contractor); David Xu Alimera, Gyroscope, Code C (Consultant/Contractor)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 2505 – F0231. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Ajay E. Kuriyan, Theo Bowe, Rebecca Russ Soares, Charles Huang, Rishi P Singh, M. Ali Ali Khan, Basil K Williams, Jayanth Sridhar, Allen Chiang, Michael Cohen, Michael Klufas, Omesh P Gupta, Yoshihiro Yonekawa, David Xu; Racial and Gender Disparities in Enrollment and Participation in Diabetic Macular Edema Clinical Trials in the United States. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2505 – F0231.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : Numerous studies have raised concerns that clinical trial cohorts are frequently demographically different from the population undergoing treatment post FDA approval. Our study describes the racial and ethnic composition of the cohorts of diabetic macular edema
(DME) clinical trials and compares this to the racial and ethnic composition of patients undergoing treatment for DME from the (Intelligent Research in Sight) IRIS ® Registry.

Methods : This is a retrospective cohort study comparing the racial/ethnicity and gender composition of patients undergoing treatment for DME from the (Intelligent Research in Sight) IRIS ® Registry and participants in Diabetic Retinopathy Clinical Research (DRCR) Retina Network clinical trials and industry sponsored trials that met the following inclusion criteria: conducted in the United States of America, Phase III completed, data reported between Jan 1, 2000, and Jan 1, 2020, and demographic information reported with results.

Results : Twenty-two clinical trials met our inclusion criteria. Seventeen were part of the DRCR and five were industry-sponsored trials. Compared to the enrollment fraction of 4.94% among Whites, lower enrollment fractions were found in Black patients (3.99%, odds ratio [OR] 0.816,
confidence interval [CI] 0.786-0.867, P< 0.001) and in Hispanic patients (2.81%, OR 0.579, CI 0.541-0.620, P<0.001). Men were more likely to enroll in the clinical trials compared to women (enrollment fraction, 4.11% vs 3.64%, respectively, OR 1.22, CI 1.074-1.172, P < 0.001).

Conclusions : DME clinical trials have a higher relative proportion of White and male subjects when compared to the population undergoing treatment for DME. Further efforts should consider measures to encourage clinical trial recruitment that is reflective of the DME population undergoing treatment to ensure generalizability of clinical trial results.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×