June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
The Impact of Volumetric Intraretinal Fluid Lability in the VISTA Clinical Trial on Functional Outcomes
Author Affiliations & Notes
  • Yavuz Cakir
    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
  • Katherine Wise
    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
  • Carmen Calabrise
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Katherine E Talcott
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Sunil K Srivastava
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Justis P. Ehlers
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Yavuz Cakir None; Sari Yordi Betty J. Powers Retina Research Fellowship , Code S (non-remunerative); Leina Lunasco None; Katherine Wise None; Hasan Cetin None; Gagan Kalra None; Christopher Mugnaini None; Carmen Calabrise None; Katherine Talcott Zeiss, Novartis, RegenxBio, Code F (Financial Support); Sunil Srivastava Bausch and Lomb, Adverum, Novartis, and Regeneron, Code C (Consultant/Contractor), Regeneron, Allergan, and Gilead, Code F (Financial Support), Leica, Code P (Patent); 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) (Cole Eye), Unrestricted Grants from The Research to Prevent Blindness, Inc (Cole Eye), Cleveland Eye Bank Foundation awarded to the Cole Eye Institute (Cole Eye), K23-EY022947-01A1 (JPE), Grant from Regeneron
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 3009 – F0279. doi:
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      Yavuz Cakir, Sari Yordi, Leina Lunasco, Katherine Wise, Hasan Cetin, Gagan Kalra, Christopher J. Mugnaini, Carmen Calabrise, Katherine E Talcott, Sunil K Srivastava, Justis P. Ehlers; The Impact of Volumetric Intraretinal Fluid Lability in the VISTA Clinical Trial on Functional Outcomes. Invest. Ophthalmol. Vis. Sci. 2022;63(7):3009 – F0279.

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

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Abstract

Purpose : To evaluate the impact of intraretinal fluid (IRF) lability in diabetic macular edema (DME) on anatomic and functional outcomes in the Phase III VISTA Clinical Trial in eyes treated with intravitreal aflibercept injection (IAI).

Methods : A post-hoc higher order image analysis was performed on eyes in the Phase III VISTA DME study. Patients were randomized to receive 2mg IAI injection every 4 weeks (2q4), IAI every 8 weeks following 5 initial monthly doses (2q8), or laser photocoagulation. This analysis focused on the 2q8 group for assessment of fluid lability, defined as a 30% increase in IRF central subfield volume (CSV) above the threshold value at week 16 (i.e., last monthly injection administration) at any timepoint between week 20 and week 52. OCT images were evaluated using a machine learning-augmented platform that extracts retinal fluid features, including volumetric characterization and compartmental retinal features, such as ellipsoid zone (EZ) integrity. Groups were compared for baseline variables and final functional outcomes.

Results : For this assessment, 139 of 148 eyes were included from the 2q8 group. There were 71 eyes (51%) that demonstrated IRF volume lability after Week 16, compared to 68 eyes (49%) that did not. Baseline comparative assessment of the 2 groups did not show a significant difference in mean IRF CSV compared to those without lability (0.15 ± 0.10 mm3 vs 0.14 ± 0.12 mm3, respectively; p=0.79) or a difference in BCVA (ETDRS: 58.2 ± 11.2 vs 61.16 ± 10.0, p=0.105). However, eyes with subsequent IRF CSV lability demonstrated greater baseline EZ attenuation [i.e. reduced EZ-RPE central subfield thickness (24.2 ± 16.0 µm vs 30.6 ± 14.8 µm, p=0.017)].
The IRF CSV lability group demonstrated significantly worse mean BCVA at Week 52 (ETDRS: 68.3±13.2 v 73.2±11.09, p=0.027) and Week 100 (68.9±14.1 v 74±11.7, p= 0.035) compared to eyes that had more stable fluid dynamics.

Conclusions : DME eyes with volumetric IRF lability exhibited worse BCVA outcomes compared to those eyes with more stable fluid dynamics. Decreased baseline EZ integrity was more significant in eyes that ultimately developed fluid lability.

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

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