At the annual Diabetic Retinopathy Clinical Research (DRCR) Retina Network Winter meeting in January 2025, Retina Associates of Western NY, P.C. was named the Diabetic Retinopathy Clinical Research (DRCR) Retina Network’s 2024 “Site of the Year.” This prestigious award is given to sites that display exemplary work on DRCR Protocols, including exceptional enrollment and retention, high-quality and accurate assessments, and all-around excellence by clinical site staff. In 2024, RAWNY was scored 1st of of 14 sites in their scored tier, as well as maintained 100% patient retention and 0 missed visits, resulting in reliable and consistent clinical data contributions to 3 different DRCR protocols. This huge honor was made possible by the tireless effort and dedication put forth by the amazing clinical research department and support staff, who enrolled over 30 patients in multiple DRCR protocols in 2024. A special thank you goes out to Site Principal Investigator Dr. Edward Hall, Protocol Principal Investigator Dr. Matthew Witmer, Clinical Research Coordinators Mary Jo Doran COA and Trista Buscemi, VA Examiners Nick Ghyzel and Mindy Burgess, and Ophthalmic Photographers Karissa Kuhl, Owen Maloy, Kelly Schmelzer and Margaret Whelehan. We would also like to thank the physicians who examine and treat our DRCR study patients every day, as well as the rest of the allied health staff at RAWNY for their support while we navigate clinical trial patients through our busy clinic schedules. In a candid interview, Vitreoretinal Surgeon and DRCR Principal Investigator Dr. Edward Hall shares his insights on the DRCR Retina Network and what it means to be named “Site of the Year.”

For those that do not know, what is the DRCR Retina Network?

The DRCR Retina Network (DRCR) is a collaborative clinical research network dedicated to improving vision and quality of life for individuals with retinal diseases. Established in 2002 and expanded in 2018 to include research on other retinal diseases such as macular degeneration and even retinal surgery, the network focuses on multicenter clinical trials, epidemiologic outcomes, and other research related to retinal disorders. The network now includes over 160 sites and 500 physicians across the U.S. and Canada. Funded by the National Eye Institute, part of the National Institutes of Health, the DRCR aims to drive advancements in retinal disease treatments through high-quality research.

How has the DRCR Retina Network changed the landscape of treating and managing DR and other retinal diseases?

The DRCR has significantly transformed the treatment and management of several important retinal diseases through large-scale clinical trials that have provided robust evidence for effective treatments. Key contributions include the establishment of evidence-based protocols for diabetic macular edema and diabetic retinopathy, particularly in helping to refine the role of anti-VEGF therapy (such as ranibizumab and aflibercept) in managing these complex diseases. Longer-term studies have helped to hone treatment strategies, informed patient management, and highlighted the importance of personalized care based on various patient-specific factors. The network’s research has also influenced the utilization of diagnostic innovations like optical coherence tomography (OCT), and improved early detection and screening methods.

Furthermore, the DRCR has advanced our understanding of retinal disease pathophysiology, and their findings have not only shaped clinical practice in the U.S. but have had a global impact, leading to better management of retinal diseases worldwide. Through education, collaboration, and a focus on patient-centered care, the DRCR has fostered a more unified, informed approach to retinal disease treatment, improving outcomes and reducing the burden of vision loss.

How do DRCR research protocols differ from other research protocols?

The DRCR research protocols distinguish themselves through a multi-center, collaborative approach that involves diverse patient populations and reflects real-world clinical practice. These protocols are rigorously designed using randomized controlled trials, long-term follow-up, and a focus on comparative effectiveness, allowing them to assess the relative merits of different treatments for conditions like diabetic retinopathy and diabetic macular edema. The network’s protocols emphasize patient-centered care, with a focus on inclusivity and individualized treatment regimens. This ensures that their findings are applicable to a wide range of patients and provide actionable insights for clinical practice.

Additionally, DRCR protocols incorporate cutting-edge diagnostic technologies, collaborate closely with regulatory bodies like the FDA and National Eye Institute (NEI), and prioritize data transparency and sharing. This commitment to advanced research methods, flexibility in treatment, and regulatory alignment allows the network’s studies to have a significant impact on the development of new treatment paradigms and their adoption into clinical practice. Most importantly, the DRCR Retina Network is free from industry (including pharmaceutical) biases, and its clinical trials are often designed to compare leading treatments head-to-head. As a result, its trial findings are among the most influential in the field.

As a retina specialist, what recent DRCR findings/outcomes do you find the most exciting?

Recent findings from the DRCR Retina Network have led to groundbreaking advancements in the treatment and management of diabetic retinopathy (DR) and diabetic macular edema (DME) and other retinal diseases, offering more effective and personalized care for patients. Key discoveries include the optimization of anti-VEGF therapies for DME, with studies showing that longer treatment intervals can reduce the treatment burden while maintaining excellent vision outcomes. Additionally, steroid implants have proven beneficial for patients with chronic or refractory DME, providing more treatment options for those who don’t respond as well to anti-VEGF agents. 

The DRCR has also helped to demonstrate the long-term benefits of anti-VEGF therapy in DR, where early intervention can help prevent progression to more advanced stages like proliferative diabetic retinopathy. However, DRCR trials have also demonstrated that there is still a role for traditional laser therapy for managing and preventing some of the complications of advanced DR. These trials are also influencing the way we manage age-related macular degeneration (AMD), and studies on extended-release anti-VEGF agents like faricimab promise to reduce injection frequency, improving patient convenience. The network’s emphasis on early detection through advanced imaging technologies and its focus on personalized treatments are paving the way for more effective and individualized care. One current study, Protocol AO, is investigating the use of an at-home monitoring device for patients with active wet AMD and helping to guide treatment intervals. Retina Associates was recently recognized as one of the top recruiting centers in the country for this innovative trial. These findings will not only improve treatment options but also enhance patient quality of life, reducing vision loss and treatment complications in the long term.

What does it mean to you for RAWNY to be named DRCR site of the year?

Being named DRCR Site of the Year is a significant honor for Retina Associates of Western New York (RAWNY), recognizing the team’s dedication to excellence in both patient care and retinal research. This designation reflects the high standards of care that RAWNY provides to patients, aligning with the latest evidence-based treatments from groundbreaking studies. It also highlights the practice’s commitment to advancing retina research, contributing to clinical trials that shape the future of treatments for a variety of retinal diseases. The recognition underscores the collaborative efforts of the entire team, including physicians, administrators, study coordinators, photographers, technicians and all of our excellent staff working together to deliver optimal care and results. I would particularly like to recognize our study coordinators, Mary Jo Doran and Trista Buscemi, for their incredible attention to detail which is truly reflected in this award!

Being named a top DRCR site also positions RAWNY as a leader in the field, building trust with patients and physicians while attracting new research opportunities. For patients, this recognition means access to the most advanced treatments and a commitment to improving outcomes in the fight against vision loss. It also brings pride to the local community, highlighting the region’s role in advancing retina care. Ultimately, this achievement serves as inspiration for continued growth and innovation in research and patient care, ensuring RAWNY remains at the forefront of retinal disease management.

In your opinion, out of the DRCR protocols currently being investigated, which do you think has the potential to make the greatest impact on the clinical management of retinal conditions?

I’m really excited about DRCR Protocol AO, which is investigating the role of a home-monitoring device in managing wet age-related macular degeneration (AMD). This study could potentially transform how we treat wet AMD patients!

In brief, patients in this trial are randomly assigned to one of two treatment arms. In the first arm, patients follow the standard of care approach, receiving anti-VEGF injections at regular intervals until their disease stabilizes, at which point the injections are spaced out. If disease activity worsens, the injection intervals are shortened based on office visits and OCT imaging findings. In the second arm, patients receive the initial anti-VEGF injection in the office, then use a small home OCT device to monitor disease activity. They only return for treatment when the device, using AI-assisted algorithms, detects recurrent activity. Safety nets are in place, including physician monitoring of the home images. At the end of this two-year trial vision outcomes will be compared in the two groups as well as the number of treatments required. The goal is to offer more personalized care, potentially improving visual outcomes while reducing the number of office visits and injections. This could greatly benefit patients, their families, and physicians by improving outcomes and lessening the treatment burden!

Tell us more about DRCR trials currently enrolling.

We are currently enrolling patients in four different DRCR protocols and are excited to announce that we will soon be adding a fifth trial!

• Protocol AF is studying the effects of fenofibrate on the progression of diabetic retinopathy. Fenofibrate, commonly used to lower cholesterol and triglycerides, may also provide protective benefits in slowing diabetic retinopathy progression.
• Protocol AFA is an extension of Protocol AF, designed to compare metabolic changes associated with diabetic retinopathy severity using specific blood markers.
• Protocol AM is a surgical clinical trial examining the optimal timing for surgical management of epiretinal membranes (macular pucker). The study will explore the risks, benefits, and visual outcomes associated with this surgery.
• Protocol AO is also actively enrolling at our site, and I have provided specific details about this study above.
• Protocol AP is an upcoming trial that will compare anti-VEGF injections combined with in-office laser treatment to vitrectomy surgery with laser in patients with advanced diabetic retinopathy. We hope to begin enrollment soon.

Dr. Edward Hall announces that RAWNY has been named DRCR’s 2024 “Site of the Year” and recognizes clinical research support staff at the Retina Associates of Western NY holiday party in January 2025.