3 minute read
Capturing the DRD Experience
Vision-threatening diabetic retinal disease (DRD) leaves no aspect of life untouched—from basic daily activities, to treasured hobbies, to regulating emotions, making decisions and interacting with others. Patients and their care teams need tools to help them speak the same language about the many functional, cognitive and emotional aspects of living with DRD, in order to inform and monitor treatment plans. Standardized qualitative and quantitative snapshots are equally essential for researchers developing and testing new interventions in clinical trials.
Kellogg retina specialist K. Thiran Jayasundera, M.D., M.S., is at the forefront of developing and validating patient-reported outcome measurement (PRO) tools for patients afflicted with retinal diseases. His customized PROs for patients with inherited retinal diseases (IRDs) have been translated into more than ten languages and are currently in use in clinical trials involving 50 centers worldwide.
The need for comprehensive, easy-to use PROs is just as great in the DRD community. Now, with startup support from the Mary Tyler Moore Vision Initiative’s Founder and CEO S. Robert Levine, M.D., (see page 28) a team led by Dr. Jayasundera is tailoring a PRO questionnaire specifically for DRD patients.
“This is not the first PRO for DRD, but it’s by far the most thorough one,” says Dr. Jayasundera. “Measures of central, color, photopic peripheral and mesopic peripheral vision, contrast sensitivity, scotopic function and photosensitivity are organized in domains corresponding to specific pathways of vision physiology. And unlike previous tools, we take a deep dive into the emotional, psychological and psychosocial aspects of living with DRD.”
“From the very start, this has been a top priority of patients, advocates, researchers and pharma leaders in our consortium,” Dr. Levine says. “MTM Vision exists to address resource gaps that impede progress toward ending vision loss from diabetes. We are thrilled to tap into Dr. Jayasundera’s expertise to expedite this crucial project.”
Assisting Dr. Jayasundera on this project are research fellows Rafid Farjo, Timothy Mayotte and Alex Zmejkoski. They are coordinating the additional support provided by specialists in ophthalmology, endocrinology, psychology and pharmaceutical development.
“Beyond measuring and trending many of the same variables we follow in IRD patients, we need to capture how worsening vision impacts the many steps patients take to manage their diabetes, like monitoring blood glucose and insulin use, and mustering the motivation to eat right, exercise and lose weight,” Farjo explains.
Following the IRD PRO model, the process of creating the DRD questionnaire began with focus groups of clinical experts, followed by a series of in-depth patient interviews. “At every step, we’ve continued to refine the topics and questions included, as more and more associations and challenges are raised,” says Mayotte.
An evaluation with 300 DRD patients is planned for fall 2024, with an ambitious goal of completing the PRO by May, 2025.
“This project is only possible thanks to the leadership of Dr. Levine and MTM Vision,” adds Dr. Jayasundera. “His involvement sparked additional support from the Macula Society, the Retina Society, and two pharmaceutical leaders. Together, we’re bringing this tool to market for use by stakeholders across the DRD community.”
