The Mary Tyler Moore Vision Initiative’s virtual workshop, “Developing Novel Endpoints for Diabetic Retinal Disease Based on the Neurovascular Unit”, kicked-off The Mary Tyler Moore Vision Initiative – Collaborative Community on Ophthalmic Innovation “DRD Cure Accelerator” Working Group’s consensus building on endpoints and biomarkers for DRD diagnosis, risk prediction, progression and treatment efficacy assessment. The identification, validation, and further development of these endpoints will concentrate on measures that recognize that DRD affects the entire retinal neurovascular unit and can assess the relationships between retinal structure and function.
Welcome
S. Robert Levine, MD, Founder and CEO, Mary Tyler Moore Vision Initiative (MTM Vision).
Setting the Stage: The need for new, consensus, DRD endpoints to facilitate medical product development and transform the clinical capacity to save and restore vision in people with diabetes.
Session 1: Clinical Assessment of Retinal Structure
Moderator: Jennifer Sun, MD, MPH, Scientific Co-Director, MTM Vision
Speakers:
- Paolo Silva, MD, Associate Professor of Ophthalmology, Joslin Diabetes Center, Harvard Medical School. Retinal nonperfusion and future risk of vision threatening complications.
- Yali Jia, PhD, Professor of Ophthalmology and Biomedical Engineering, Jennie P. Weeks Professor of Ophthalmology, and associate director of the Center for Ophthalmic Optics & Lasers, Oregon Health & Science University (OHSU). AI driven assessment of nonperfusion on optical coherence tomography angiography (OCTA).
- Elliott Sohn, MD, FASRS, FARVO, Professor, Ophthalmology and Visual Sciences, University of Iowa. Retinal neurodegeneration may precede microvascular changes characteristic of diabetic retinopathy in diabetes mellitus.
- Stela Vujosevic, MD, PhD, FARVO, FEBO, Professor and Head of the Medical Retina Unit, University Eye Clinic, San Giuseppe Hospital, Milano, Italy. Disorganization of retinal inner and outer layers (DRIL/ DROL) and visual function in diabetic retinopathy (DR).
- Discussion (Q&A)
Session 2: Cellular and Molecular Markers of DRD
Moderator: Patrice Fort, PhD, Director, MTM Vision Ocular Biorepository & Resource Center
Speakers:
- Chandra Balaratnasingam, MD, PhD, Clinical Professor, University of Western Australia Medical School, Centre for Ophthalmology and Visual Science (affiliated with the Lions Eye Institute). The pathophysiology of DRD and its relation to visual function.
- Patrice Fort, PhD, Director, MTM Vision Ocular Biorepository & Resource Center. Changes in the retinal neurovascular unit at the cellular level in DRD.
- Discussion (Q&A)
Session 3: Assessment of the Function of Retinal Neurovascular Unit
Moderator: Thomas Gardner, MD, MS, Science Co-Director, MTM Vision.
Speakers:
- José-Alain Sahel, MD, Distinguished Professor and Chairman of the Department of Ophthalmology University of Pittsburgh Medical School, The Eye and Ear Foundation Endowed Chair. Measuring functional vision through mobility testing and virtual reality (learning from IRD).
- Jason McAnany, PhD, Professor; Director, Clinical Psychophysics and Electrophysiology Laboratory, Department of Ophthalmology and Visual Sciences, University of Illinois. Mechanistic insights from visual function testing in DRD.
- Luis Lesmes, PhD, CEO, Adaptive Sensory Technology. Contrast sensitivity in DRD.
- Discussion (Q&A)
Session 4: Validating Novel Clinical Outcome Assessments
Moderator: S. Robert Levine, MD, Founder and CEO, MTM Vision.
Speakers:
- Olivia Meyerhoffer, Global Value Lead, Boehringer-Ingelheim Pharmaceuticals. Priorities and concerns from patients with diabetes.
- Amanda Bicket, MD, Assistant Professor, Ophthalmology and Visual Sciences, University of Michigan. Gait assessment as an outcome to assess functional vision.
- Discussion (Q&A)
Session 5: Translation to Action
Moderator: Malvina Eydelman, MD, CEO, Collaborative Community on Ophthalmic Innovation (CCOI).
Speakers:
- Malvina Eydelman, MD, CEO, CCOI. Role of CCOI in building consensus on endpoints for DRD.
- Michael Abramoff, MD, PhD, The Robert C. Watzke, MD Professor in Retina Research, Professor of Ophthalmology and Visual Sciences, University of Iowa. Practical matters in identifying/validating endpoints and biomarkers for medical product development.
- Katie Capanna, MBA, Associate Office Director for Strategic Development, Office of Strategic Programs & Technology Innovation, Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). FDA Home as a Healthcare Hub: CDRH Initiative to Enable Healthier Living.
- Discussion (Q&A)
Concluding Remarks
Thomas Gardner, MD, MS, Science Co-Director, MTM Vision.
