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Exploring Trial Endpoints in Geographic Atrophy Based on Localized Functional Changes in Microperimetry and

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This study links optical coherence tomography (OCT) biomarkers like retinal pigment epithelium (RPE) and ellipsoid zone (EZ) loss to visual function in geographic atrophy (GA). These findings support developing new treatments for GA by correlating structural damage with retinal sensitivity.

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Area of Science:

  • Ophthalmology
  • Medical Imaging
  • Biomedical Engineering

Background:

  • Geographic atrophy (GA) is a leading cause of vision loss.
  • Novel therapeutics for GA require validated functional endpoints.
  • Optical coherence tomography (OCT) reveals structural biomarkers like retinal pigment epithelium (RPE) and ellipsoid zone (EZ) loss.

Purpose of the Study:

  • To establish a pointwise structure/function correlation between OCT biomarkers and retinal sensitivity (RS) in GA.
  • To define functional correlates of high-risk OCT biomarkers for GA.
  • To support the development of functional endpoints for clinical trials and regulatory approval of GA therapeutics.

Main Methods:

  • Analysis of patients from the OAKS phase III clinical trial (NCT03525613).
  • Quantification of RPE and EZ loss/thickness using deep-learning (DL) algorithms on OCT images.
  • Co-registration of microperimetry (MP) stimulus locations with OCT B-scans.
  • Multivariable mixed-effect modeling to correlate OCT biomarkers with RS, adjusting for eccentricity.

Main Results:

  • Mean RS was 17 dB in intact retina, 9 dB in EZ loss areas, and 2 dB in RPE loss areas.
  • Increased EZ thickness correlated with improved RS (0.2 dB/µm).
  • EZ loss reduced RS by -8 dB, while RPE loss reduced RS by -14 dB, both significantly (P < 0.001).

Conclusions:

  • A significant association was established between MP-measured RS and OCT-identified EZ and RPE loss using DL.
  • Quantitative structure/function correlations provide a basis for developing functional endpoints in GA.
  • This research aids in the clinical care and approval of novel GA therapeutics.