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Modest and Variable Correlations Between Geographic Atrophy Enlargement Rates in Fellow Eyes in the AREDS2 Study.

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Correlation between fellow eyes in geographic atrophy (GA) enlargement rates is modest, not strong. This finding necessitates caution in clinical trials assuming high correlation for internal controls in geographic atrophy research.

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Area of Science:

  • Ophthalmology
  • Retinal Diseases
  • Medical Statistics

Background:

  • Bilateral geographic atrophy (GA) fellow eye enlargement rates are often assumed to be highly correlated.
  • This assumption underpins treatment effect inferences and trial designs using fellow eyes as internal controls.

Purpose of the Study:

  • To quantify the correlation in GA enlargement rates between fellow eyes.
  • To evaluate the influence of GA characteristics and data transformations on this correlation.

Main Methods:

  • Post hoc analysis of the Age-Related Eye Disease Study 2 (AREDS2) cohort.
  • Pearson correlation coefficient calculated for 2-year GA enlargement rates using planimetry of fundus photographs.
  • Rates analyzed untransformed, square root-transformed, and perimeter-adjusted, stratified by GA characteristics.

Main Results:

  • Correlation in GA enlargement rates between fellow eyes was modest (untransformed: r=0.51; square root: r=0.38; perimeter-adjusted: r=0.11).
  • Correlation varied significantly based on GA characteristics (area, location, focality, RPD status) and data transformation method.
  • Genuine biological correlation, reflected by linear enlargement, was weak to moderate.

Conclusions:

  • The correlation in fellow eye GA enlargement rates is only modest, challenging assumptions used in trial design and analysis.
  • GA characteristics and data transformation methods significantly impact observed correlations.
  • Researchers should exercise caution when relying on highly correlated fellow eye enlargement rates in clinical studies.