Translational Research Core

National Eye Institute

Investigators

Linked publications & trials

Abstract

The mission of Translational Research CORE (TRC) is to offer up-to-date instrumentation, technical and scientific expertise to investigators translating eye function findings into the Clinic. In our CORE, we established and maintained a set of animal models accepted by the FDA and can be used to provide validation data for IND submissions. We also maintain CORE staff with a unique expertise: Surgeon, Veterinarian, Anesthesiologist, and Husbandry specialists who have extensive research background and understanding of FDA requirements needed to help, advise and support all translational/clinical efforts. Apart from the help in collecting data, we are also actively engaged in modifying and adjusting techniques, tools, methodologies, and all other components necessary to satisfy FDA standards for IND submission and use in human clinical trials; help in evaluating FDA-compliant product use in a surgery room environment and serve as an unbiased evaluator of preclinical findings; assist in the preparation of a preclinical proposal to include critical elements needed for successful IND approval. TRC actively participates in several ongoing projects to bring the most promising research findings into the Clinic based on our ongoing and planned efforts. We currently collect preclinical data using large RPE implants in rat models to determine possible immunological adverse events and implant integration challenges. We are also in the process of refining surgical techniques for iPS-RPE tissue replacement Clinical trials and Surgeon training. We also continue to pursue therapeutic interventions to restore vision caused by combat eye injuries in soldiers under the Outer Retina Reconstruction for Combat Afflictions project. Preclinical data have been generated in all projects to support translational efforts and therapies.