June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Comparative Assessment of Baseline and Longitudinal Higher-Order OCT Features in the Phase III VISTA Clinical Trial Based on Race
Author Affiliations & Notes
  • Victoria Whitmore
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Sari Yordi
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Leina Lunasco
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Hasan Cetin
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Gagan Kalra
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Christopher J. Mugnaini
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Katherine Wise
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Carmen Calabrise
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Katherine Talcott
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Sunil K Srivastava
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Jamie Reese
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Justis P. Ehlers
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Victoria Whitmore None; Sari Yordi Betty J. Powers Retina Research Fellowship, Code F (Financial Support); Leina Lunasco None; Hasan Cetin None; Gagan Kalra None; Christopher Mugnaini None; Katherine Wise None; Carmen Calabrise None; Katherine Talcott Zeiss, Novartis, RegenxBio, Code F (Financial Support); Sunil Srivastava Bausch and Lomb, Adverum, Novartis, Regeneron, Code C (Consultant/Contractor), Regeneron, Allergan, Gilead, Code F (Financial Support), Leica, Code P (Patent); Jamie Reese None; Justis Ehlers Aerpio, Alcon, Allegro, Allergan, Genentech/Roche, Novartis, Thrombogenics/Oxurion, Leica, Zeiss, Regeneron, Santen, Stealth, Adverum, IvericBio, Apellis, Boehringer-Ingelheim, RegenxBio, Code C (Consultant/Contractor), Aerpio, Alcon, Thrombogenics/Oxurion, Regeneron, Genentech, Novartis, Allergan, Boehringer-Ingelheim, IvericBio, Adverum, Code F (Financial Support), Leica, Code P (Patent)
  • Footnotes
    Support  NIH-NEI P30 Core Grant IP30EY025585; Unrestricted Grants from The Research to Prevent Blindness, Inc; Cleveland Eye Bank Foundation awarded to the Cole Eye Institute; K23-EY022947-01A1; Grant from Regeneron
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 2508 – F0234. doi:
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      Victoria Whitmore, Sari Yordi, Leina Lunasco, Hasan Cetin, Gagan Kalra, Christopher J. Mugnaini, Katherine Wise, Carmen Calabrise, Katherine Talcott, Sunil K Srivastava, Jamie Reese, Justis P. Ehlers; Comparative Assessment of Baseline and Longitudinal Higher-Order OCT Features in the Phase III VISTA Clinical Trial Based on Race. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2508 – F0234.

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

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Abstract

Purpose : To evaluate the baseline and longitudinal higher order OCT features in the Phase III VISTA diabetic macular edema (DME) clinical trial based on race.

Methods : This was a post-hoc analysis of the Phase III VISTA-DME clinical trial, which included patients randomized 1:1 to receive 2mg IAI every 4 weeks or 8 weeks after 5 initial monthly doses. Higher-order OCT analysis conducted with a machine learning-enhanced feature extraction and multi-compartment segmentation platform enabled evaluation of volumetric fluid features and compartmental retinal integrity (e.g. EZ integrity). Specific features included mean central subfield thickness (CST), intraretinal fluid (IRF) volume, EZ-RPE panmacular volume and total EZ attenuation. Retinal anatomic dynamics and BCVA changes were compared and stratified by reported race. Patients self-reported as White (n=198), Black/African American (n=25), Asian (n=5), American Indian/Native Alaskan (n=1) and Not Reported (n=3). Only White (W) and Black/African American (B/AA) patients were included in analysis due to subject quantity.

Results : At baseline, age and clinical characteristics such as systolic blood pressure, BMI, duration of diabetes and BCVA were similar between W and B/AA (all p>0.05) (Table 1). Diastolic blood pressure was higher in B/AA (74.4 vs 77.7 mmHg, p=0.033). At Baseline and at Week 100, CST, IRF volume, EZ-RPE volume, EZ total attenuation and BCVA were similar between W and B/AA (all p>0.05).

From Baseline to Week 100 (Table 2), W and B/AA showed significant improvement in CST (-191.6±156.2µm, -236.8±200.5µm respectively, p<0.01 from baseline) and IRF Volume (-1.2±1.4 mm3, -1.2±2.5 mm3, p=0.021 from baseline). However, while W showed significant improvement in EZ-RPE volume (+1.3±0.2mm3, p<0.01) and EZ total attenuation (-0.7±4.0%, p=0.016), B/AA demonstrated a nonsignificant improvement in both (p=0.20, p=0.65 respectively). W and B/AA showed significant improvement in BCVA during that period (p<0.01).

Conclusions : Higher order OCT DME features and longitudinal response to IAI demonstrated similar features and findings when comparing based on race. Both groups demonstrated significant anatomic and functional improvements with IAI.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

 

Table 1: Distribution and Baseline Values of Subjects. P value: Compares W and B/AA. Bold: significant.

Table 1: Distribution and Baseline Values of Subjects. P value: Compares W and B/AA. Bold: significant.

 

Table 2: Mean Change from Baseline to Week 100. P value: Baseline vs Week 100

Table 2: Mean Change from Baseline to Week 100. P value: Baseline vs Week 100

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