June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
A post hoc analysis of vitreous haze from the SATURN study comparing investigator, central reading center, and image-derived quantitative scores
Author Affiliations & Notes
  • Karl Landheer
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Nicholas Giangreco
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Shane McCarthy
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Sunil K Srivastava
    Cleveland Clinic, Cleveland, Ohio, United States
  • Farshid Sepehrband
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Mary Germino
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Makis Parasoglou
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Karen Chu
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Matthew Wipperman
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Sara Hamon
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Charles Miller
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Jonathan Weyne
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Footnotes
    Commercial Relationships   Karl Landheer Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Nicholas Giangreco Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Shane McCarthy Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Sunil Srivastava Eyepoint, Regeneron, Santen Allergan Novartis, Regeneron Phamaceuticals, Bausch and Lomb, Eyepoint, Eyevensys, Abbvie, Zeiss, Code C (Consultant/Contractor), Eyepoint, Regeneron Pharmaceuticals, Allergan, Santen, Code F (Financial Support); Farshid Sepehrband Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Mary Germino Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Makis Parasoglou Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Karen Chu Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Matthew Wipperman Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Sara Hamon Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Charles Miller Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest); Jonathan Weyne Regeneron Pharmaceuticals, Code E (Employment), Regeneron Pharmaceuticals, Code I (Personal Financial Interest)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 5004. doi:
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      Karl Landheer, Nicholas Giangreco, Shane McCarthy, Sunil K Srivastava, Farshid Sepehrband, Mary Germino, Makis Parasoglou, Karen Chu, Matthew Wipperman, Sara Hamon, Charles Miller, Jonathan Weyne; A post hoc analysis of vitreous haze from the SATURN study comparing investigator, central reading center, and image-derived quantitative scores. Invest. Ophthalmol. Vis. Sci. 2023;64(8):5004.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Subjective grading of vitreous haze (VH), a key clinical feature of posterior segment uveitis, presents challenges as a clinical trial endpoint. The SATURN study utilized the Miami 9-Step Scale, with investigators grading by fundoscopy, and a central reading center grading color fundus photographs (CFP), rating VH from 0 (no haze) to 8 (extreme haze). We compare investigators’ assessments of VH (iVH), scores from the central reading center (cVH), and an unbiased quantitative VH index (qVH) derived from optical coherence tomography (OCT).

Methods : The SATURN study was a phase 2 randomized controlled trial evaluating sarilumab in 58 patients with non-infectious, intermediate, posterior or panuveitis. Investigators used the Miami 9-Step Scale to grade VH at baseline and at 17 postbaseline visits and CFP were also graded at a central reading center. We used the weighted kappa statistic to evaluate agreement and the binomial test to evaluate bias in disagreement between iVH and cVH (N=53). We then compared iVH and cVH each with OCT-derived qVH in a subset of patients (N=15).

Results : There was weak agreement between investigators’ and central readers’ VH scores at baseline (weighted kappa=0.40, 95% confidence interval [0.26,0.54]) and post-baseline (weighted kappa=0.35, 95% CI [0.29, 0.41]). Moreover, iVH was upwardly biased compared to cVH both at baseline (Binomial test p-value=0.003) and post-baseline (Binomial test p-value=0.04). In 15 patients, qVH showed correlations with cVH at baseline (Spearman correlation= 0.77, P-value=0.00086) and post-baseline (Spearman correlation=0.38, P-value=2.4E-7).

Conclusions : We show that vitreous haze assessments in SATURN differ between investigator and central reading center grading of CFP. Additionally, we show there is greater correlation between qVH and cVH, which may be a function of both methods relying on image acquisition through mid-vitreous, versus fundoscopy assessing the entire vitreous cavity. This may represent an opportunity to incorporate image-derived, quantitative measures in clinical trials.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

Investigator VH score (iVH) versus the central reader VH score (cVH) at baseline (left) and post-baseline (right).

Investigator VH score (iVH) versus the central reader VH score (cVH) at baseline (left) and post-baseline (right).

 

Spearman correlation (blue line) between iVH (top) or cVH (bottom) and OCT VH index at baseline (left), and post-baseline (right).

Spearman correlation (blue line) between iVH (top) or cVH (bottom) and OCT VH index at baseline (left), and post-baseline (right).

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