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Diagnosing Diabetic Neuropathy: Something Old, Something New.

Ioannis N Petropoulos1, Georgios Ponirakis1, Adnan Khan1

  • 1Division of Research, Weill Cornell Medicine Qatar, Doha, Qatar.

Diabetes & Metabolism Journal
|August 24, 2018
PubMed
Summary

Diabetic peripheral neuropathy (DPN) assessment needs better biomarkers. Corneal confocal microscopy (CCM) shows promise as a non-invasive tool meeting FDA requirements for clinical trials, aiding drug discovery.

Keywords:
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Area of Science:

  • Ophthalmology
  • Neurology
  • Biomarker Discovery

Background:

  • Diabetic peripheral neuropathy (DPN) diagnosis lacks FDA-approved surrogate endpoints for clinical trials.
  • Current assessment methods like sensory testing and electrodiagnostics have failed to serve as reliable endpoints.
  • There is a critical need for validated biomarkers to track DPN progression and facilitate therapeutic development.

Purpose of the Study:

  • To evaluate corneal confocal microscopy (CCM) as a potential surrogate endpoint for DPN.
  • To determine if CCM meets U.S. Food and Drug Administration (FDA) criteria for assessing therapeutic benefit in DPN clinical trials.

Main Methods:

  • Utilized corneal confocal microscopy (CCM), a non-invasive ophthalmic imaging technique.
  • Focused on the in vivo evaluation of corneal sensory C-fibers.

Main Results:

  • Corneal confocal microscopy (CCM) demonstrated potential as a reliable method for assessing DPN.
  • Evidence suggests CCM fulfills FDA criteria for use as a surrogate endpoint in DPN studies.

Conclusions:

  • Corneal confocal microscopy (CCM) emerges as a promising non-invasive biomarker for diabetic peripheral neuropathy.
  • CCM may meet FDA requirements, facilitating clinical trials and drug discovery for DPN.