DoW Vision, Clinical Trial Award

The Defense Health Agency Vision Research Program Clinical Trial Award is a federal funding opportunity administered through the Congressionally Directed Medical Research Programs under the Defense Health Agency Research and Development office. The funding opportunity supports rapid implementation of clinical trials that have the potential to significantly improve the treatment or management of service-connected eye injury and visual dysfunction affecting Service Members, Veterans, and their families. The program aligns with the broader Vision Research Program mission of transforming visual system trauma care for the Armed Forces and the nation. Since its inception in 2009, the Vision Research Program has focused on understanding and treating visual injuries associated with combat exposure, traumatic brain injury, and damage caused by explosive devices. The fiscal year 2026 appropriation for the program is $10 million, and approximately $2.6 million is expected to support one Clinical Trial Award. The Clinical Trial Award specifically funds human clinical trials and does not support preclinical research or non-trial clinical research. Eligible projects may range from pilot or first-in-human studies through larger efficacy trials involving drugs, biologics, medical devices, clinical guidance, or emerging treatment approaches. Applications must address at least one of the designated fiscal year 2026 Vision Research Program focus areas. These include understanding and treating eye injury or visual dysfunction related to military exposure, diagnosing and treating eye injuries in austere or prolonged care environments, and restoring visual function after military exposure-related vision loss or severe impairment. The funding announcement strongly encourages multidisciplinary collaborations among academia, industry, Department of War organizations, the Department of Veterans Affairs, and other federal entities to maximize access to patient populations, infrastructure, and translational expertise. The funding opportunity allows a maximum total project cost of $2.6 million for a project period not exceeding three years. Approximately one award is anticipated. Applicants may request the full funding amount even if the proposed project duration is shorter than the maximum performance period. Allowable expenses include personnel, research activities, participant reimbursement, travel supporting multi-institutional collaboration, and travel for up to two investigators to attend one Department of War-sponsored meeting in the Central Florida area during years two or three of the project. Additional travel support for one scientific or technical meeting per year may also be requested. Costs associated with excessive conference travel are prohibited. Cost sharing or matching funds are not required for eligibility. Eligible applicants include domestic and foreign organizations, nonprofit and for-profit organizations, public and private entities, intramural Department of War organizations, and independent investigators affiliated with eligible institutions regardless of citizenship or nationality. Awards are made to organizations rather than individuals. Applications involving investigational drugs or devices requiring Investigational New Drug or Investigational Device Exemption authorization must submit the regulatory application to the appropriate regulatory agency no later than the application deadline. Applicants must also provide documentation showing the regulatory submission is active or safe to proceed by March 1, 2027. Failure to provide this documentation may result in administrative withdrawal of the application. Clinical trials are expected to begin within six months of award issuance. The application process uses a mandatory two-step submission structure. Applicants first submit a pre-application through the Electronic Biomedical Research Application Portal. The preproposal narrative is limited to two pages and must summarize the study rationale, intervention, trial phase, design, feasibility, and anticipated impact on outcomes following vision injury. Applicants invited to advance then submit a full application through Grants.gov for extramural organizations or eBRAP for intramural Department of War organizations. Full applications require numerous components including a twenty-page project narrative, supporting documentation, technical and lay abstracts, a statement of work, a study population recruitment and safety plan, a regulatory strategy attachment, study personnel and organizational plans, transition planning documents, military relevance statements, and detailed budget materials. The review process evaluates clinical impact, research strategy, recruitment feasibility, regulatory readiness, statistical analysis, ethical considerations, personnel qualifications, and military relevance. The timeline for the funding opportunity begins with a pre-application submission deadline of July 28, 2026, followed by invitation notifications in September 2026. Full applications are due November 12, 2026, and the verification period closes November 17, 2026. Peer review is scheduled for January 2027 and programmatic review for March 2027. Awards are expected to be issued no later than September 30, 2027. The opportunity is recurring because the Vision Research Program conducts annual fiscal year competitions. Technical assistance is available through the eBRAP Help Desk at help@eBRAP.org and 301-682-5507, while Grants.gov technical support is available at support@grants.gov and 800-518-4726. The opportunity requires active registrations in SAM.gov, Grants.gov, and eBRAP before submission. Applicants are strongly advised to begin registration and preparation early because there are no grace periods for missed deadlines.

Provide strong evidence that the clinical trial is ready to begin quickly and feasible within the project period. Demonstrate access to the study population and intervention source. Include rigorous statistical power analysis and mitigation plans for recruitment challenges. Clearly explain military relevance and clinical impact for Service Members and Veterans. Ensure IND or IDE submissions are completed before the application deadline if applicable.