NIH-DP3: Biomarkers for Diabetes Complications: Non-Invasive Measures in the Eye


Specific Areas of Research:

This FOA seeks applications for research projects that use human subjects or data from human subjects, not only using animal models. The project can include research and data on human subjects with Type 1 or Type 2 diabetes, but the biomarker must be relevant to patients with Type 1 diabetes.

The projects may be at the stage of translation of preclinical research into humans or of a validated biomarker for another disease or condition to the detection and measurement of diabetes complications. The project may also optimize methods previously validated in humans to make them easily portable and achievable in eye clinics.

The biomarkers under study should be non-invasive imaging of the eye, which may include agents administered as eye drops or by intravenous injection. Invasive testing may be included, if used for the purpose of determining the extent of diabetes complications in other tissues.

Research that involves longitudinal data on the progression and regression of the biomarker and diabetic complications is of high priority in order to establish the biomarker as a surrogate end-point. Clinical and ancillary studies to an ongoing clinical study can be proposed.

The application: should clearly define how the proposed research furthers the development of the biomarker on a path leading to its clinical acceptance. If the research involves a comparison of the new biomarker with existing biomarkers, the choice of those tests and their strengths and weaknesses should be described. In addition, the application should provide justification for the clinical need of the proposed biomarker. A high priority will be given to projects that fill a unique need in the assessment of diabetes complications, rather than make incremental changes in the measurement or detection of a diabetes complication.

Research topics: including, but not limited to:

i. Measurement of longitudinal changes in retinal vein and artery diameters in fundus photographs from diabetic patients in well-characterized cohorts.

ii. Image analysis to explore the correlation between the density and conformation of retinal vessels and corneal nerves with cross-sectional or longitudinal data on the presence or absence of diabetes complications.

iii. Application to diabetes complications of new retinal imaging systems that allow visualization at the molecular level to assess for damage from hyperglycemia.

iv. Validation and optimization of confocal microscopy measurements of corneal nerves as a measure of diabetic neuropathy.

v. Development of molecular probes to detect changes on the luminal surface of the endothelium as a marker for systemic vascular damage.

vi. Measurement of retinal vessels with provocative testing to determine changes in vascular responsiveness due to diabetes and their association with metabolic control or risk of diabetes complications.

Termini IISPV

1- Declaration of interest: IISPV’s deadline: January 31st, 2014 (

2- NIH Register; create PI account(s); affiliate PI account to IISPV, etc.

3- Letter of Intent: IISPV’s deadline: February 25th, 2014.

4. Full proposal: IISPV’s deadline: March 27th, 2014

Termini Oficial

Official deadline (Letter of Intent): March 7th, 2014
Full Application deadline: April 7th, 2014

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