The purpose of this FOA is the rapid and efficient translation of innovative laboratory research findings into therapies, devices or other resources for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological interventions, such as gene therapy, cell-based therapy, pharmacological approaches, and/or medical devices. The ultimate goal of this program is to make new technological, biological and pharmacological resources available to clinicians and their patients.

Each project should have a well-defined endpoint of developing a device or treatment for a specific ocular disease that is achievable within a five-year time frame.

The steps towards this goal should be clearly delineated in a series of milestones that support the development of a device or therapeutic that will lead to an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the FDA and/or testing in a clinical trial. If successful, a project funded under this program should lead to filing an IND-directed pharmacological and toxicological study, an Investigational Device Exception IDE-directed clinical study, Phase I clinical testing, and/or a subsequent application for a NEI UG1 Clinical Vision Research Grant or a R34 Clinical Study Development Grant.

Applications that include preclinical studies involving animals will be supported by this FOA.

NIH-defined clinical trial applications (see NOT-OD-15-015) are not supported by this FOA except for those that are mechanistic trials or those that involve minimal risk as defined by 45 CFR 46.

A mechanistic trial is defined as "A study designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention." 

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

As part of the review process, the application must include a clear, detailed plan for monitoring safety that is commensurate with the risks to study participants. In addition to the minimal risk designation from the Institutional Review Board, other reporting to the NEI may be required and will be outlined in the Notice of Award Terms and Conditions.

See Notices of Special Interest associated with this funding opportunity.

Application Deadlines:  April 13, 2021; February 9, 2022; February 9, 2023

PAR-20-319 Expiration Date: New Date October 14, 2022 per issuance of NOT-EY-22-017. (Original Expiration Date: A April 14, 2023 )