Diabetic Retinal Disease Cure Accelerator modernizes staging

The Diabetic Retinal Disease Cure Accelerator is a joint effort by the Mary Tyler Moore Vision Initiative and the Collaborative Community on Ophthalmic Innovation to update how diabetic retinal disease is classified and measured in research and care. A 2026 review described the project as an effort to modernize “clinically meaningful staging systems and endpoints” for diabetic retinal disease, or DRD. (sciencedirect.com) S. Robert Levine, founder and CEO of the Mary Tyler Moore Vision Initiative, said in July 2025 that a central problem is that current risk stratification and trial endpoints are “outmoded and insensitive.” He said the accelerator is trying to validate objective surrogate markers and clinical endpoints that could support faster product development and more precise treatment. (tvst.arvojournals.org) ### Why are they calling it diabetic retinal disease instead of diabetic retinopathy? A 2023 workshop report said the field is increasingly using “diabetic retinal disease” because diabetes affects the full retinal neurovascular unit, not only the visible microvascular lesions captured in older grading systems. (sciencedirect.com) The same report said traditional severity systems are based on decades-old photographic scales that do not include the midperipheral retina, are not quantitative, and do not explain mechanisms of vision impairment well. Jennifer K. Sun, Lloyd Paul Aiello, Michael D. (ophthalmologytimes.com) Abràmoff and co-authors wrote in *Ophthalmology* that advances in imaging, recognition of neurodegeneration, and newer functional assessments support an updated DRD staging system. They said staging systems should reflect disease biology, serve as research endpoints, and predict clinically important future events. ### What is wrong with the current staging system? The ETDRS Diabetic Retinopathy Severity Scale remains the main research standard, but it was built around seven-field color fundus photography and primarily vascular findings. (ncbi.nlm.nih.gov) Sun and co-authors said neither ETDRS nor the simpler international grading scale is quantitative or linear, and both focus on the posterior retina without accounting for the periphery. Retinal Physician wrote in June 2024 that the ETDRS DRSS still serves as the “gold standard” in trials, with the scale running from 10 for no retinopathy to 85 for advanced proliferative disease and 61 marking mild proliferative diabetic retinopathy. (pmc.ncbi.nlm.nih.gov) The same article said step changes on the DRSS became important trial endpoints because they predicted progression to proliferative and sight-threatening disease over one, three and five years. ### What is the accelerator trying to add? The October 22, 2022 MTM Vision clinical endpoints workshop brought together more than 90 patient representatives, clinicians, scientists, regulators and industry participants to discuss new diagnostic and therapeutic approaches. (pmc.ncbi.nlm.nih.gov) The workshop report said Phase I priorities included updating the DRD staging system and severity scale, building a human ocular biorepository, and developing and validating clinical endpoints and biomarkers. A May 2025 symposium report said experts also highlighted clinically relevant endpoints, novel biomarkers for early disease change, big-data strategies, artificial intelligence tools, and stronger patient-reported outcomes and quality-of-life measures. (retinalphysician.com) That report said patient voices and caregiver support were part of the discussion, alongside tissue collection and multi-omics work through the MTM Vision Biorepository and Resource Center. ### Why does this matter for trials now? Levine said in 2025 that the accelerator is aimed at objective surrogate markers and endpoints that regulators, developers and clinicians can use across studies. (ncbi.nlm.nih.gov) He said upcoming work includes two observational clinical studies with the DRCR Retina Network focused on functional vision measures such as contrast sensitivity and electroretinography, alongside the 2,500-subject French EVIRED study and a forthcoming patient-reported outcome measure. That matters because newer therapies may affect more than the lesion patterns emphasized in older scales. (tvst.arvojournals.org) The 2020 *Ophthalmology* article said updated staging should better address early disease, progression, treatment development and treatment effectiveness. ### What should readers watch next? The May 2025 TVST report said MTM Vision is advancing two clinical trials in collaboration with the DRCR Retina Network and expanding its pre-competitive consortium, which had added Boehringer Ingelheim as its first founding industry member. Levine said in July 2025 that the endpoint program is meant to feed translation, regulatory approval and adoption, with more data expected from the observational studies and related framework-building work. (ophthalmologytimes.com) (tvst.arvojournals.org) (pmc.ncbi.nlm.nih.gov)