DoD Vision Clinical Trial Award | HT9425 23 VRP CTA

Opportunity Information: Apply for HT9425 23 VRP CTA

The DoD Vision Clinical Trial Award (FY23 VRP CTA; Funding Opportunity Number HT9425 23 VRP CTA) is a Department of Defense vision research funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA). Its purpose is to speed the launch of early-phase clinical trials, specifically phase 0 through phase 2a, that test new interventions aimed at improving the treatment or day-to-day management of service-connected eye injuries and visual dysfunction. The focus is on interventions that could make a meaningful difference for affected service members and veterans, and the program is set up to move promising ideas into human testing quickly rather than supporting basic or purely preclinical work.

This mechanism is strictly for clinical trials, meaning the proposed project must prospectively assign one or more human participants to one or more interventions (including placebo or other controls when appropriate) in order to evaluate effects on biomedical or behavioral health-related outcomes. In practical terms, the trial needs to be designed to measure safety, effectiveness, and/or efficacy of an intervention. Projects that do not include these kinds of intervention outcome measurements, or that are essentially preclinical studies, are not considered responsive for this award and are directed to other Vision Research Program announcements instead.

The types of interventions supported are broad as long as they fit the early-phase clinical trial requirement and are relevant to service-connected vision problems. Examples named in the announcement include new products, pharmacologic agents (drugs or biologics), medical devices, clinical guidance, and emerging approaches or technologies. The intent is to fund trials that are ready for near-term implementation, not concepts that still need substantial preliminary development before they can be tested in people.

A major emphasis of the announcement is regulatory readiness. For drugs not already FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application may be required under 21 CFR 312, and it must be specific to the product and indication being tested (not a related derivative or alternate version). For investigational devices, an Investigational Device Exemption (IDE) may be required under 21 CFR 812, also specific to the device and intended indication. Applicants are responsible for demonstrating when an IND or IDE is not required, or when a device qualifies for an abbreviated IDE. If an IND or IDE is required, it must be submitted by the application deadline, and the applicant must provide documentation from the FDA indicating the submission is active or safe to proceed by March 1, 2024 for the application to remain eligible for funding consideration. If the trial will run at international sites, similar documentation from the relevant national regulatory agencies is required by the same date.

Operationally, the DoD expects funded trials to start quickly: the clinical trial is expected to begin no later than six months after the award date. There are also clear public transparency and compliance requirements. Funded studies must be registered on ClinicalTrials.gov before initiating the study, and awardees must post a copy of the informed consent form used to enroll subjects on a publicly available federal website, consistent with federal human subjects requirements (referenced as 32 CFR 219). These requirements align the award with standard expectations for human subjects protection, trial transparency, and public accountability.

In terms of who can apply, eligibility is listed as unrestricted, meaning it is open to essentially any type of organization, subject to any additional clarifications in the full announcement. The award will be made as an assistance agreement, which can be either a grant or a cooperative agreement. Which one is used depends on the anticipated level of DoD involvement during the project. If the DoD does not expect substantial involvement, it will be structured as a grant (31 USC 6304). If substantial involvement is expected, such as collaboration, participation, or intervention in the work, it will be structured as a cooperative agreement (31 USC 6305), and the specific nature of that involvement will be spelled out in the award. The start date and final award type are determined during negotiations.

Key administrative details from the posting include that it is a discretionary funding opportunity in the Science and Technology/Research and Development category (CFDA 12.420). The opportunity was created May 11, 2023, with an original application closing date of November 8, 2023. The notice indicates an expected number of awards of one. The award ceiling is listed as 0 in the source data, which typically signals that applicants must rely on the program announcement itself for budgeting limits or that the ceiling is not specified in the summary field.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Vision Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on May 11, 2023.
• Applicants must submit their applications by Nov 08, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for HT9425 23 VRP CTA

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