June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Baseline Characterization of Advanced Ellipsoid Zone Integrity Features in the GATHER1 Phase 2/3 Clinical Trial for AMD with Geographic Atrophy
Author Affiliations & Notes
  • Reem Amine
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Sari Yordi
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Hasan Cetin
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Conor Anthony McConville
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Gagan Kalra
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Yavuz Cakir
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Victoria Eileen Whitmore
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Jamie Reese
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Julie Clark
    IVERIC Bio, Cranbury, New Jersey, United States
  • Liansheng Zhu
    IVERIC Bio, Cranbury, New Jersey, United States
  • Sunil K Srivastava
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Justis P Ehlers
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Reem Amine None; Sari Yordi Betty J Powers Retina Research Fellowship, Code S (non-remunerative); Hasan Cetin None; Conor McConville None; Gagan Kalra None; Yavuz Cakir None; Victoria Whitmore None; Jamie Reese None; Julie Clark IVERIC Bio, Code E (Employment); Liansheng Zhu IVERIC Bio, Code E (Employment); Sunil Srivastava Bausch and Lomb, Adverum, Novartis, Regeneron, Code C (Consultant/Contractor), Regeneron, Allergan, 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, Iveric BIO, Apellis, Boehringer-Ingelheim, RegenxBIO, Code C (Consultant/Contractor), Aerpio, Alcon, Thrombogenics/Oxurion, Regeneron, Genentech, Novartis, Allergan, Boehringer-Ingelheim, Iveric Bio, Adverum, Code F (Financial Support), Leica, Code P (Patent)
  • Footnotes
    Support  P30EY025585(BA-A), Research to Prevent Blindness (RPB) Challenge Grant, Cleveland Eye Bank Foundation Grant
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2265. doi:
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      Reem Amine, Sari Yordi, Hasan Cetin, Conor Anthony McConville, Gagan Kalra, Yavuz Cakir, Victoria Eileen Whitmore, Jamie Reese, Julie Clark, Liansheng Zhu, Sunil K Srivastava, Justis P Ehlers; Baseline Characterization of Advanced Ellipsoid Zone Integrity Features in the GATHER1 Phase 2/3 Clinical Trial for AMD with Geographic Atrophy. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2265.

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

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Abstract

Purpose : Ellipsoid zone (EZ) integrity has been demonstrated to be a key marker of disease burden, functional loss, and progression risk in dry age-related macular degeneration (AMD). The purpose of this analysis was to characterize baseline EZ integrity features in eyes with AMD and geographic atrophy (GA) in the GATHER1 Phase 2/3 Clinical Trial.

Methods : GATHER1 study is a prospective, randomized, double-masked, phase 2/3 trial evaluating Avacincaptad Pegol (ACP) in patients with geographic atrophy (GA) secondary to AMD. All baseline analyzable SD-OCT scans were imported into a machine learning-enhanced multi-layer retinal segmentation platform, that enabled panmacular and zonal measures of EZ integrity as well as OCT-defined areas of GA. Each scan was reviewed by a trained expert image analyst and segmentation errors were corrected as needed.
Panmacular partial and total EZ attenuation (%) was determined by the percentage of macular cube with EZ-RPE thickness ≤ 20 μm and EZ-RPE = 0 μm, respectively. The total EZ-GA gap (%) was calculated by taking the difference between EZ total attenuation and GA occupied areas, calculated based on areas of total attenuation of the RPE (i.e., RPE-BM = 0 μm). This measure reflects the overall total EZ loss within areas of retina that have not already developed GA. In addition, the partial EZ-GA gap (%) was calculated as the difference between the EZ partial attenuation and GA area percentages.

Results : One hundred and ninety four subjects (194 eyes) were included in this baseline analysis of the GATHER1 study. The mean EZ partial attenuation among subjects was 45.78 % [median = 42.33%; range = 10.58 to 98.22%]; whereas the mean EZ total attenuation was 32.56 % [median = 30.05%; range = 3.89 to 82.66%]. The mean total EZ-GA gap was 11.08 % [median = 7.83%; range = 0 to 61.68%]. The mean partial EZ-GA gap was 24.31 % [median = 19.10%; range = 2.46 to 84.4%].

Conclusions : In the GATHER1 study, EZ integrity metrics demonstrated a wide-range of baseline degenerative changes, including in excess of underlying GA. Future analysis will evaluate the impact of these baseline EZ integrity on disease progression risk and also potentially assess differential impact of ACP on GA progression based on underlying EZ loss profiles.

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

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