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GCL loss in BRAO.

Thomas R Shearer1, Peter N Steinkamp2, Maria Parker2

  • 1Department of Integrative Biomedical & Diagnostic Sciences, Oregon Health & Science University, Portland, Oregon, United States of America.

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|January 5, 2023
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Optical coherence tomography (OCT) can track retinal thinning in branch retinal artery occlusion (BRAO). This method helps predict patient numbers and trial duration for calpain inhibitor studies in BRAO and central retinal artery occlusion (CRAO).

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Area of Science:

  • Ophthalmology
  • Retinal Vascular Diseases
  • Medical Imaging

Background:

  • Branch retinal artery occlusion (BRAO) and central retinal artery occlusion (CRAO) involve thinning of retinal inner layers.
  • Proteolysis by calpain, a calcium-activated protease, may contribute to this thinning.
  • Calpain inhibitors have shown promise in ameliorating proteolysis in experimental models.

Purpose of the Study:

  • To compare retinal layer loss in BRAO patients with CRAO patients using optical coherence tomography (OCT) segmentation analysis.
  • To predict the required sample size and observation duration for clinical trials of calpain inhibitors in BRAO.

Main Methods:

  • Retrospective case-control study using OCT images from BRAO patients.
  • Computer-aided search of medical records and manual correction of auto-segmentation errors.
  • Analysis of retinal ganglion cell layer (GCL) thickness changes over time, utilizing Cohen's d and sample size statistics.

Main Results:

  • Retinal ganglion cell layer (GCL) thickness decreased rapidly in BRAO, similar to CRAO but in fewer quadrants.
  • GCL thickness changes, fitted to a single-phase decay curve, can inform clinical trial sample size calculations.
  • A 60-day trial with a 60% effective calpain inhibitor would require a minimum of 29 BRAO patients.

Conclusions:

  • Monitoring GCL thickness changes via OCT is a practical approach for assessing BRAO and CRAO progression.
  • This method facilitates human clinical trials with feasible patient numbers and trial durations.
  • GCL thickness serves as a valuable indicator for evaluating the efficacy of inhibitors in BRAO and CRAO clinical trials.