DoD FY15 Vision Research Program Technology/Therapeutic Development Award by Department of Defense

The FY15/16 VRP Technology/Therapeutic Development Award (TTDA) is a mission-driven award intended to provide support for the translation of promising preclinical findings into products for clinical applications, including detection, diagnosis, treatment, or quality of life, in at least one of the FY15/16 VRP TTDA Capability Gaps.

Products in development should be responsive to the health care needs of military Service members, Veterans, and other individuals living with visual dysfunction. NOTE: In keeping with the intent of this award mechanism, at the end of this period of performance, this work should be sufficient to support an Investigational Device Exemption (IDE), Investigational New Drug (IND) or continue to clinical trials (where applicable).
The product(s) to be developed may be a tangible item such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product such as clinical guidance for standard of care. The Principal Investigator (PI) must provide a transition plan (including potential funding and resources) showing how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the completion of the VRP award.

Proof-of-concept demonstrating the potential utility of the proposed product, or a prototype/preliminary version of the proposed product, should already be established. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.

Examples of the types of research that may be supported include, but are not limited to: Testing new therapeutic modalities (agents, delivery systems, and chemical modification of lead compounds) using established or validated preclinical systems; Designing and implementing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or delivery systems for use in advanced preclinical trials; Developing pharmacologic agents through preclinical absorption, distribution, metabolism, excretion, and toxicity (ADMET) studies; Developing pharmacologic agents to IND stage for eventual initiation of Phase I clinical trials; Developing prototype devices to the IDE stage for eventual initiation of clinical trials; Preclinical optimization of diagnostic or treatment devices for field deployment.

To meet the intent of the FY15/16 VRP Technology/Therapeutic Development Award (TTDA), the research proposals must address one or more of the Capability Gaps listed below:
Inadequate mitigation and treatment of damage to ocular structures and the visual system consequent to military-relevant injuries and diseases incident to military service. Research into ocular damage that occurs in the general public will also be considered, as there may be similarities and related treatments in the two populations; Inadequate treatments and technologies for injuries and diseases to ocular structures and visual systems to include, optic neuropathy, retinal injury, lid and adnexal injuries and ocular polytrauma; Inadequate strategies and techniques for controlling scarring and/or pathological healing response in traumatized ocular tissues; Inadequate intraocular devices or tamponade agents for retinal detachment repair compatible with aeromedical evacuation.
Inadequate vision restoration and regeneration: Inability to restore form and function of lids, adnexal, orbital and ocular tissues (optic nerve, cornea, retina, and uvea) following injury.
Lack of knowledge, capabilities, and equipment for early responders to diagnose and mitigate military-relevant eye injuries and diseases in austere or remote environments; Lack of methods and/or devices to assist in the location of entrance wounds and rupture sites in traumatic eye injuries; Lack of portable diagnostic tools and technologies for field use to detect ocular injuries and diseases.