Published in Retina

Equity in Trials, Clarity in Vision: The Value of Inclusive Research and Mentorship

This is editorially independent content supported by advertising from Regeneron
8 min read

Join John Kitchens, MD, and Joseph Coney, MD, FACS, to learn how inclusive research and mentorship in retina positively impact patients and trainees.

On this episode of Retina Mentor Moments, John W. Kitchens, MD, is joined by Joseph M. Coney, MD, FACS, to discuss how trainees can carve their path in retina and the importance of inclusive clinical trials.
Dr. Coney is a vitreoretinal specialist and partner at the Retina Associates of Cleveland in Ohio, and has been a clinical investigator in over 65 studies on vitreoretinal diseases.

The value of supportive mentorship during training

Dr. Coney explained that growing up on the South Side of Chicago, he encountered obstacles early in his career, as mentors and counselors discouraged him from pursuing medicine, despite his strong academic performance. He added that once he entered medical school, he faced challenges as the only Black man in his class, and after graduating, he was again discouraged from pursuing a career in ophthalmology.
Having to navigate these challenges without a supportive mentor who understood his experiences made him feel self-conscious and unsure of himself, making the journey of finding confidence in his authentic self and voice even more difficult. However, his parents instilled him with lessons that gave him the determination to overcome these barriers and persevere to find his passion.

Conquering impostor syndrome early in your retina career

Due to his experiences during training, Dr. Coney explained that he struggled with impostor syndrome and emphasized that saying yes to opportunities early in your career and growing a network of like-minded individuals is the best way to overcome it.
As such, he surrounded himself with mentors and colleagues who encouraged him to develop his authentic voice and inspired him to grow. In addition, he prioritizes being a mentor to early-career retina specialists as well as those in his community to help foster trust and build a supportive network for individuals navigating similar challenges.
Dr. Kitchens echoed this sentiment, adding that having people around who truly love retina makes work fun and creates endless opportunities for career growth. This mentality also extends to choosing a retina practice after training, as Dr. Coney recommended trainees find a practice that will look out for their best interests and want to help them develop into better people and doctors.

To hear more career advice for trainees and early-career retina specialists, watch the full interview!

Enrolling patients in clinical trials that address unmet needs

When evaluating clinical trials, Dr. Coney always assesses whether the study addresses an unmet need, which in retina tends to mean the intervention is a novel therapy or is more durable or safer than existing treatments.
Of note, his practice tends to wait until a drug reaches at least phase 3 clinical trials before considering enrolling patients to ensure they are not exposing patients to a therapy with a high risk of adverse events.
An additional consideration for clinical trials is the targeted patient population. As he has a particular passion for diabetic retinopathy (DR), he often looks at the structure of DR trials—specifically the inclusion and exclusion criteria—to discern whether the therapy could be prescribed to the patients he treats at his clinic.

Treating patients from underrepresented communities in medicine

Unfortunately, many DR trials exclude patients from traditionally underrepresented communities due to tight requirements, including HbA1c levels (which can be capped at 10%), kidney function, and high blood pressure. Dr. Coney explained that his practice treats a significant number of Black and Hispanic patients, who are more likely to suffer from complications of diabetes like DR, while also typically undergoing less frequent screening.1
This results in patients often presenting to the clinic with more advanced disease and co-occurring conditions. As such, these patients at higher risk of severe disease lack a presence in these trials and consequently have less access to cutting-edge therapies.
Currently, he is very interested in developments in gene therapies and port delivery systems, as he believes these could address unmet needs with durable treatments that his patients would strongly benefit from having access to.

ELEVATUM: An example of inclusive research

Recently, ELEVATUM (NCT05224102), a phase 4, multicenter, open-label, 1-year trial, evaluated the safety and efficacy of faricimab-svoa (VABYSMO, Genentech / Roche) in traditionally underrepresented, treatment-naive patients with diabetic macular edema (DME).2 This study, sponsored by Genentech / Roche, focused not only on ocular outcomes but also on social determinants of health to elucidate social, health, and operational barriers that limit recruitment and retention in this patient population.
Of the 124 included patients, 45% self-identified as Hispanic or Latino, and 48% as Black or African American.2 Participants received intravitreal faricimab 6.0mg every 4 weeks up to week 20, then the treatment interval was extended to every 8 weeks up to week 52, with a final safety follow-up visit at week 56.
Key ocular inclusion criteria included central subfield thickness (CST) ≥325μm and best-corrected visual acuity (BCVA) ~20/40 to 20/400 (20 to 73 ETDRS letters).2 In addition, eligibility criteria allowed participants with an HbA1c level up to 12%.
In October 2024, Genentech announced positive topline 1-year results, wherein Hispanic and Latino participants had an average vision gain of 14.1 letters from baseline, and African American and Black participants gained an average of 11.3 letters from baseline.3 The study cohort achieved an average decrease in CST of 206.3μm from baseline.
Moreover, VABYSMO was well-tolerated, no new safety events were reported, and results were consistent with the phase 3 YOSEMITE and RHINE DME studies.3

To learn more about how retina specialists can contribute to efforts to make clinical trials more inclusive, watch the video!

Tips for introducing new retina treatments into your practice

Dr. Coney prefers to wait until several thousand people have received treatment with a new medication before starting patients, as issues may arise during real-world practice that were not uncovered in clinical trials.
In addition, he opts to recommend new anti-VEGF therapies to recalcitrant patients with a high disease burden, as they have already tested other therapies with little to no success.

Discussing geographic atrophy therapies with patients

With the development and approval of two intravitreal complement inhibitor injections for geographic atrophy (GA), thorough patient education has been crucial to achieving success with these treatments. He added that the best thing he can do for patients is help them understand what the medication can offer them and its limits so they can make an educated decision.
Furthermore, he explained that the patient’s journey guides the discussion, as visual acuity measures in the clinic may not fully capture the entire picture of how the patient’s vision is affected by GA.

Conclusion

Dr. Coney’s career journey offers valuable guidance for trainees navigating early career challenges, identifying unmet needs in patient populations, supporting inclusive research opportunities, and introducing new therapies with patient-centered communication.
  1. Coney JM, Scott AW. Racial disparities in the screening and treatment of diabetic retinopathy. J Natl Med Assoc. 2022 Apr;114(2):171-181. doi:10.1016/j.jnma.2021.12.011
  2. Brown J, Cunningham M, Coney JM, et al. Elevatum study design and rationale: a phase 4 trial of faricimab (VABYSMO) in underrepresented patients with DME. Invest Ophthalmol Vis Sci. 2024 Jun;65:6242. https://iovs.arvojournals.org/article.aspx?articleid=2795361
  3. Genentech’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study. Genentech. October 18, 2024. Accessed June 25, 2025. https://www.gene.com/media/press-releases/15041/2024-10-18/genentechs-vabysmo-improved-vision-in-un.
John W. Kitchens, MD
About John W. Kitchens, MD

John W. Kitchens, MD, received his undergraduate degree from the University of Evansville, and his Doctor of Medicine degree from Indiana University School of Medicine. He served his ophthalmology residency at the University of Iowa Hospital. Dr. Kitchens completed his fellowship and was the chief resident at Bascom Palmer Eye Institute in Miami.

Dr. Kitchens enjoys speaking both nationally and internationally about new treatments for age-related macular degeneration (AMD), diabetes, and vascular disease. Dr. Kitchens has developed several innovative surgical techniques and has been awarded the American Society Retina Specialists “Rhett Buckler” Award on three different occasions.

John W. Kitchens, MD
Joseph M. Coney, MD, FACS
About Joseph M. Coney, MD, FACS

Joseph M. Coney, MD, FACS, received his BS degree in biology from the University of Illinois at Urbana-Champaign. He received his MD degree from Loyola Stritch School of Medicine. He completed his ophthalmology residency at Case Western Reserve University and a medical retina fellowship in diabetic retinopathy at the Joslin Diabetes Clinic of Harvard Medical School in Boston, Massachusetts.

Dr. Coney also finished a 2-year vitreoretinal surgical fellowship at the Vitreoretinal Foundation in Memphis, Tennessee. He serves as president for both the Cleveland Ophthalmological Society and the Ophthalmology Section of the National Medical Association. He has been a clinical investigator in over 65 research studies of treatments for diabetic retinopathy, age-related macular degeneration, and other vitreoretinal diseases.

In addition, he has been recognized as among the top ophthalmologists in the nation by Castle Connolly, and has been featured as a Top Doctor in Cleveland Magazine every year since 2015. He is a Vitals Patient's Choice, On-Time Doctor, and Compassionate Doctor award winner, and he was selected by his peers for inclusion in Best Doctors in America.

Dr. Coney's primary interests include diabetic retinopathy, age-related macular degeneration, traumatic eye injuries, and complex retinal surgeries. He speaks locally, nationally, and internationally about retinal vascular diseases.

Joseph M. Coney, MD, FACS
How would you rate the quality of this content?
Eyes On Eyecare Site Sponsors
Astellas Logo