The National Eye Institute (NEI), part of the National Institutes of Health (NIH), has issued a funding opportunity for the NEI Collaborative Clinical Vision Research: Chair's Grant (UG1 - Clinical Trial Required) under Notice of Funding Opportunity (NOFO) Number PAR-23-209. This funding opportunity supports investigator-initiated large-scale clinical trials, human gene transfer, stem cell therapy trials, and other complex or high-risk clinical trials focused on vision disorders. The grant aims to facilitate research in screening, diagnosing, preventing, or treating vision disorders and comparing the effectiveness of existing interventions.

The Chair's Grant provides scientific, clinical, and technical leadership for the development and implementation of study protocols in multicenter or high-resource clinical trials. It covers study design, research methodologies, patient populations, and implementation procedures. The NEI UG1-supported studies typically include multiple components such as the Chair’s Grant, the Coordinating Center, and Resource Centers. Separate applications are required for Coordinating Centers (which focus on statistical, logistical, and safety oversight) and Resource Centers (which provide expertise in imaging, laboratory, or other services).

Funding is available for projects with a maximum duration of five years. The budget is not capped but must reflect the actual needs of the study. The number of awards granted depends on available NIH funding and the merit of submitted applications. Applicants must propose clinical trials that evaluate screening, diagnostic, preventative, or therapeutic interventions for vision disorders. Renewal applications are permitted if they seek additional funds to complete the original study aims or to extend follow-up for long-term outcome assessments. The NOFO does not support preclinical, developmental, or preparatory studies for gene transfer or stem cell therapy, or minimal-risk studies.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, county governments, city or township governments, tribal governments (both federally and non-federally recognized), public housing authorities, independent school districts, regional organizations, and foreign institutions. There is no cost-sharing requirement for this grant. Foreign components are allowed under NIH policy. Applicants must register with multiple federal systems, including SAM.gov, Grants.gov, and eRA Commons, before submission.

Applications are due by 5:00 PM local time of the applicant's organization. The application cycle follows NIH standard due dates:

Upcoming deadlines: July 13, 2023; September 25, 2023; January 25, 2024; May 25, 2024; September 25, 2024, and continues through January 25, 2026.
Earliest Start Dates: April 2024, July 2024, December 2024, April 2025, July 2025, December 2025, and beyond.
Expiration Date: May 26, 2026.
Applications must be submitted electronically through Grants.gov or the NIH ASSIST system. Required documents include a Clinical Protocol, Milestone Plan, Study Organization Plan, Manual of Procedures, and, if applicable, documentation on intervention availability. Applications must also comply with NIH’s Data Management and Sharing Policy.

The review process includes an NIH peer review group evaluation, followed by an advisory council review. Applications will be assessed based on significance, investigator qualifications, innovation, approach, environment, study design, statistical analysis, data management, and safety monitoring. Successful applications will receive a Notice of Award (NoA) and must adhere to NIH terms and conditions, including reporting obligations and ClinicalTrials.gov registration requirements.

For questions or assistance, applicants can contact:

Scientific/Research Contacts:
Dr. Sangeeta Bhargava (bhargavas@mail.nih.gov, 301-435-8175)
Donald Everett (everettd@mail.nih.gov, 301-435-8181)
Dr. Jimmy Le (jimmy.le@nih.gov, 301-435-8160)
Peer Review Contact:
Dr. Brian Hoshaw (brian.hoshaw@nih.gov, 301-402-0566)
Financial/Grants Management Contact:
Karen Robinson Smith (Karen.Robinson.Smith@nei.nih.gov, 301-435-8178)