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<meta name="description" content="Members of the National Eye Institute&#039;s Audacious Goals Initiative (AGI) published an outline of milestones to reach before commencing clinical trials of regenerative therapies for retinal disease." />
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<title>Putting regenerative therapies on the map | National Eye Institute</title>
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<span>Putting regenerative therapies on the map</span>
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Eye institute publishes roadmap for taking audacious goals to clinical trials
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October 23, 2023
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<a href="/about/news-and-events/news?topic=12" hreflang="en">Glaucoma</a>
<a href="/about/news-and-events/news?topic=364" hreflang="en">Regenerative Medicine</a>
<a href="/about/news-and-events/news?topic=7" hreflang="en">Retina</a>
<a href="/about/news-and-events/news?topic=57" hreflang="en">Retinitis Pigmentosa</a>
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<a href="/about/news-and-events/news?initiatives=203" hreflang="en">Audacious Goals Initiative</a>
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<p>Members of the National Eye Institute's Audacious Goals Initiative (AGI) published an outline of milestones to reach before commencing clinical trials of regenerative therapies for retinal disease.</p><p>"We are now at a point where it becomes feasible to draft the roadmap that would be used to translate AGI preclinical findings into clinical trials for people who have irreversibly lost vision from retinal and optic nerve disease," the authors wrote in a commentary published by the journal Med.<sup>1</sup></p><p>Irreversible blindness often results from conditions that cause the loss of light-sensing photoreceptors and other retinal neurons, such as retinal ganglion cells, which carry signals from the retina to the brain. Examples include the blinding diseases glaucoma and age-related macular degeneration. Less common causes include injury and rare inherited diseases such as retinitis pigmentosa.</p><p>NEI launched the AGI in 2014 to foster research of regenerative therapies for eye disease. With AGI funding, researchers have advanced retinal imaging technology, discovered factors that affect neuronal regeneration, and characterized models for testing potential therapies.</p><p>If preclinical findings can be translated to human use, it would revolutionize the lives of millions of people worldwide, according to the authors.</p><p>The article outlines safety considerations; patient selection, including which disease to go after first; biomarkers and endpoints to measure efficacy; clinical controls; regulatory factors; and commercial viability.</p><p>The report is a follow-on to the authors' report on progress in regenerative medicine research for vision.<sup>2</sup></p>
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<ol><li>Levin LA, Chiang MF, Dyer MA, et al. Translational roadmap for regenerative therapies of eye disease. Med. Sep 8 2023;4(9):583-590. doi:<a href="https://pubmed.ncbi.nlm.nih.gov/37689055/">10.1016/j.medj.2023.06.005</a></li><li>Van Gelder RN, Chiang MF, Dyer MA, Greenwell TN, Levin LA, Wong RO, Svendsen CN. Regenerative and restorative medicine for eye disease. Nature Medicine. 2022/06/01 2022;28(6):1149-1156. doi:<a href="https://pubmed.ncbi.nlm.nih.gov/35715505/">10.1038/s41591-022-01862-8</a></li></ol>
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