Injectable and Biodegradable Vitreous Substitute to Restore Vision Function Following Retinal Detachment
Abstract
Rationale: The eye is filled with a jelly-like material, the vitreous, which holds everything in place, including the retina, which is responsible for vision. With traumatic brain injury, concussions, or just with age, the retina can detach, resulting in blindness if left untreated. The retina can be re-secured in place by, first, using a laser for re-attachment, followed by injection of a vitreous substitute. The dilemma is that current vitreous substitutes are problematic. Patients typically have blurred vision for 3 weeks, which impedes their ability to work and serve. Moreover, when treated with gases, patients have to lie face down for several days and cannot fly, whereas when they are treated with oils, patients usually require a second surgery. The current vitreous substitutes are sub-optimal, to say the least, and negatively impact quality of life. We surveyed over 120 patients and over 25 ophthalmologists and all were dissatisfied with current options. We invented a completely new strategy to overcome blindness due to retina detachment. Specifically, we invented a vitreous substitute comprised of a hydrogel (think of a water-swollen material like JELL-O). While others have tried similar approaches, they have all failed due to a lack of attention to the chemical strategy of the hydrogel. Objective: Our goal is to design and produce a vitreous substitute that will enable patients to see immediately after surgery and with all of the physical and biological attributes required for success. Aims: We propose three aims: (1) Synthesize the novel hydrogel in a scaled-up, sterile manner and characterize it thoroughly for physical properties: transparency, refractive index, density, all of which should match that of the normal eye. (2) Test the novel hydrogel in rabbit eyes to ensure safety and efficacy. (3) Test the novel hydrogel in dog eyes to ensure efficacy. Short-Term Outcomes: Based on our extensive experience in the design, synthesis, and testing of hydrogel vitreous substitutes, we are confident that we can achieve all of our aims within the three-year program. Specifically, we are confident that we can scale-up the production of our new vitreous substitute and prove that it is safe and efficacious in animal models of retina detachment. Long-Term Outcomes: We have already shared our cutting-edge research ideas and preliminary results with the leading ophthalmology companies. By further de-risking this new vitreous substitute critical to vision restoration, we are confident that we can advance this research toward the clinic and specifically get regulatory approval to initiate clinical trials. Outcomes advance visual system trauma care for Service Members, Veterans, and the American Public: The incidence of retinal detachment is 1 in 300 for the American public and higher for Service Members and Veterans due to the additional risks of traumatic brain injury and concussion. With our innovative vitreous substitute, we will restore vision immediately and overcome the problems associated with current, sub-optimal products. Moreover, our product will open up new avenues of investigation and is critical to advanced research involving gene therapy and cell therapy, where the native vitreous is removed. Importantly, by demonstrating that we have a reproducible, sterile manufacturing method for scale-up, and safety and efficacy in two different animal models, we will make significant advancements toward clinical translation.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110947
Entities
People
- Molly Shoichet
Organizations
- United States Army
- University of Toronto