June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Impact of baseline retinal nonperfusion on best corrected visual acuity in eyes with central retinal vein occlusion: post hoc analyses of COPERNICUS and GALILEO
Author Affiliations & Notes
  • David M Brown
    Retina Consultants of Houston, Houston, Texas, United States
  • Yuichiro Ogura
    Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
  • Francesco Boscia
    University of Sassari, Sassari, Italy
  • Frank G Holz
    University of Bonn, Bonn, Germany
  • Jean-Francois Korobelnik
    CHU de Bordeaux, Bordeaux, France
  • Jeffrey Heier
    Ophthalmic Consultants of Boston, Boston, Massachusetts, United States
  • Kay D Rittenhouse
    Bayer Pharmaceuticals, Whippany, New Jersey, United States
  • Friedrich Asmus
    Bayer Pharmaceuticals, Berlin, Germany
  • Christiane Ahlers
    Bayer Pharmaceuticals, Berlin, Germany
  • Florian Hiemeyer
    Bayer Pharmaceuticals, Berlin, Germany
  • Chengxing Lu
    Bayer Pharmaceuticals, Whippany, New Jersey, United States
  • Robert Vitti
    Regeneron Pharmaceuticals, Tarrytown, New York, United States
  • Namrata Saroj
    Regeneron Pharmaceuticals, Tarrytown, New York, United States
  • Nicolas Feltgen
    University of Göttingen, Göttingen, Germany
  • Footnotes
    Commercial Relationships   David Brown, Aerpio, Alcon, Allegro, Allergan, Ampio, Astellas, Avalanche, Bayer, Clearside, Genentech, Iconic, National Eye Institute, Neurotech, Novartis, Ophthotech, Pfizer, Regeneron, Roche, Santen, ThromboGenics, and Xcovery (F), Alimera, Allergan, Avalanche, Bayer, Clearside, Eleven Biotherapeutics, Genentech, Heidelberg Engineering, Kowa, Liquidia, Novartis, Optos, Optovue, QLT, Quantel Medical, Regeneron, Stealth BioTherapeutics, Thrombogenics, Xcovery, Xoma, and Zeiss (C); Yuichiro Ogura, Alcon, Janssen Pharma, and Wakamoto (C), Bausch and Lomb, Bayer, Kissei Pharma, Kowa, Novartis, Santen, Sanwa Kagaku, Senju, and Topcon (F); Francesco Boscia, Novartis, Bayer, Alcon, ThromboGenics, Alimera, Pfenex, and Allergan (C), Novartis and Bayer (F); Frank Holz, Acucela, Genentech, Novartis, Bayer, Alcon, OPTOS, Heidelberg Engineering, Carl Zeiss Meditec, Allergan, and Pfizer (C), OPTOS, Heidelberg Engineering, Carl Zeiss Meditec, Alcon, Genentech, Bayer, and Novartis (F); Jean-Francois Korobelnik, Alcon, Alimera, Allergan, Bayer, Horus, Novartis, Roche, Thea, and Zeiss (C); Jeffrey Heier, Acucela, Aerpio, Allergan, Allergo, Avalanche, CoDa Therapeutics, Eleven Biotherapeutics, EyeGate Pharmaceuticals, Forsight Biotherapeutics, Forsight Vision 4, Genentech, Icon Therapeutics, Janssen, Kala, Kanghong, Kato Pharmaceuticals, Lpath, NanoRetina, Ohr Pharmaceuticals, Regeneron Pharmaceuticals, Inc., RestorGenex, RetroSense, Scifluor, Shire, Stealth BioTherapeutics, Thrombogenics, and Valeant (C), Acucela, Apellis, Astellas, Corcept, Daiichi, EyeGate Pharmaceuticals, Genentech, Genzyme, Kala, Neurotech, Novartis, Ophthotech, Stealth BioTherapeutics, and Thrombogenics (F); Kay Rittenhouse, Bayer Pharmaceuticals (E); Friedrich Asmus, Bayer Pharmaceuticals (E); Christiane Ahlers, Bayer Pharmaceuticals (E); Florian Hiemeyer, Bayer Pharmaceuticals (E); Chengxing Lu, Bayer Pharmaceuticals (E); Robert Vitti, Regeneron Pharmaceuticals (E); Namrata Saroj, Regeneron Pharmaceuticals (E); Nicolas Feltgen, Alimera, Allergan, Bayer HealthCare, and Novartis (C), Allergan, Bayer HealthCare, and Novartis (F)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1559. doi:
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      David M Brown, Yuichiro Ogura, Francesco Boscia, Frank G Holz, Jean-Francois Korobelnik, Jeffrey Heier, Kay D Rittenhouse, Friedrich Asmus, Christiane Ahlers, Florian Hiemeyer, Chengxing Lu, Robert Vitti, Namrata Saroj, Nicolas Feltgen; Impact of baseline retinal nonperfusion on best corrected visual acuity in eyes with central retinal vein occlusion: post hoc analyses of COPERNICUS and GALILEO. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1559.

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

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Abstract

Purpose : Retinal nonperfusion may be an important factor impacting the efficacy of anti-VEGF agents in macular edema (ME) due to central retinal vein occlusion (CRVO). This post hoc analysis evaluates its role in COPERNICUS and GALILEO.

Methods : Patients with ME due to CRVO were randomized (3:2) to receive IAI 2 mg or sham monthly for 24 weeks. From Week 24 (W24) until W52, all IAI–treated patients in both studies and the sham-treated patients in COPERNICUS were eligible to receive IAI based on visual and anatomical criteria. In these post hoc analyses, eyes were classified as having any macular retinal nonperfusion (MNP) determined by fluorescein angiography (FA) within the ETDRS field centered on the macula and as meeting the historic Central Vein Occlusion Study (CVOS) criteria of “ischemia” (CVOS “ischemic” Group [≥10 DA of nonperfusion on FA anywhere in the standard fundus seven subfields]). The association between eyes with any MNP and eyes with ≥10 DA of nonperfusion at BL were assessed by the kappa coefficient. Data from COPERNICUS and GALILEO were integrated.

Results : At BL, 51 eyes had ≥10 DA of nonperfusion in 7 standard fields; of these, 48 (94.1%) had MNP and 3 (5.9%) had no MNP. Of the 230 eyes with <10 DA nonperfusion in 7 standard fields at BL, 156 (67.8%) had MNP and 74 (32.2%) had no MNP. Distribution of retinal perfusion status was balanced between the IAI and sham groups. There was low agreement between BL macular perfusion status and BL CVOS “ischemic” criteria (Kappa=0.12). The treatment effects at W52 with respect to mean changes in BCVA from BL were consistent regardless of BL retinal perfusion status in 7 standard fields or MNP status for IAI (+14.2 to 16.7 letters) versus sham (+0.6 to 5.6 letters). By W52, the most frequent ocular serious adverse events were vitreous hemorrhage in COPERNICUS (3.2% of patients) and ME in GALILEO (3.5%). There were 3 Anti-Platelet Trialists’ Collaboration–defined arterial thromboembolic events in COPERNICUS (IAI, n=1; sham, n=2) and none in GALILEO.

Conclusions : In COPERNICUS and GALILEO, which included eyes meeting historic CVOS “ischemic” criteria and eyes with MNP, the treatment benefit of IAI on mean change in BCVA was robust and similar regardless of these BL characteristics.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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