June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Eighteen-Month Results of the GALILEO Study Evaluating Intravitreal Aflibercept Injection (IAI) for Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Author Affiliations & Notes
  • Yuichiro Ogura
    Department of Ophthalmology, Nagoya City University Medical School, Nagoya, Japan
  • Jean-Francois Korobelnik
    Department of Ophthalmology, CHU Bordeaux, Universite Bordeuax, Bordeaux, France
  • Johann Roider
    Department of Ophthalmology, University Medical Center Schleswig-Holstein, Kiel, Germany
  • Robert Vitti
    Regeneron Pharmaceuticals Inc., Tarrytown, NY
  • Frank Holz
    Department of Ophthalmology, University of Bonn, Bonn, Germany
  • Florian Hiemeyer
    Bayer Healthcare, Berlin, Germany
  • Brigitte Stemper
    Bayer Healthcare, Berlin, Germany
  • Oliver Zeitz
    Bayer Healthcare, Berlin, Germany
  • Rupert Sandbrink
    Bayer Healthcare, Berlin, Germany
  • Footnotes
    Commercial Relationships Yuichiro Ogura, None; Jean-Francois Korobelnik, Alcon (C), Allergan (C), Bayer (C), Carl Zeiss Meditec (C), Novartis (C), Thea (F); Johann Roider, Novartis (F), Bayer (F); Robert Vitti, None; Frank Holz, Acucela (C), Allergan (C), Genentech (F), Heidelberg Engineering (F), Zeiss (F), Novartis (F), Novartis (C), Optos (F), Merz (C), Bayer (F), Bayer (C), Boehringer Ingelheim (C); Florian Hiemeyer, Bayer AG (E), Bayer AG (I); Brigitte Stemper, Bayer Pharma (E); Oliver Zeitz, Bayer HealthCare (E); Rupert Sandbrink, Bayer HealthCare (E), Bayer HealthCare (I)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 4516. doi:
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      Yuichiro Ogura, Jean-Francois Korobelnik, Johann Roider, Robert Vitti, Frank Holz, Florian Hiemeyer, Brigitte Stemper, Oliver Zeitz, Rupert Sandbrink, ; Eighteen-Month Results of the GALILEO Study Evaluating Intravitreal Aflibercept Injection (IAI) for Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). Invest. Ophthalmol. Vis. Sci. 2013;54(15):4516.

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

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Abstract

Purpose: To evaluate the efficacy and safety of IAI for treatment of macular edema due to central retinal vein occlusion (CRVO).

Methods: This double-masked, multicenter, 18-month, phase 3 trial randomized patients to receive either IAI 2 mg (IAI 2q4) (n=106) or sham (n=71) injections every 4 weeks up to Week 24. From Week 24 to 52, IAI patients were evaluated monthly and received IAI pro re nata (PRN) (IAI 2q4-PRN), and sham patients continued to receive monthly sham injections. From Week 52 to Week 76, all patients were evaluated every 8 weeks and received IAI PRN (IAI 2q4-PRN and sham-IAI PRN). The primary efficacy endpoint was the proportion of patients who gained ≥15 letters at Week 24.

Results: The proportion of patients who gained ≥15 letters was 60.2% vs 22.1% at Week 24 (P<0.0001), 60.2% vs 32.4% (P=0.0004) at Week 52, and 57.3% vs 29.4% at Week 76 (P<0.01) in the IAI 2q4-PRN and sham-IAI PRN groups, respectively. The mean increase from baseline visual acuity was 18.0 vs 3.3 letters (P<0.0001) at Week 24, 16.9 vs 3.8 letters (P<0.0001) at Week 52, and 13.7 vs 6.2 letters at Week 76 in the IAI 2q4-PRN and sham-IAI PRN groups. The mean reduction from baseline central retinal thickness was 448.6 vs 169.3 µm (P<0.0001) at Week 24, 423.5 vs 219.3 µm (P<0.0001) at Week 52, and 389.4 vs 306.4 µm at Week 76 in the IAI 2q4-PRN and sham-IAI PRN groups. The mean (SD) number of PRN IAI injections was 2.5 (1.7) in the IAI 2q4-PRN group from Weeks 24 to 52, and 1.3 (1.1) vs 1.7 (1.1) injections in the IAI 2q4-PRN and sham-IAI PRN groups, respectively, from Weeks 52 to 76. Over the 76 weeks, the most frequent ocular serious adverse events in the IAI 2q4-PRN and sham-IAI PRN groups were macular edema (3.8% vs 2.9%), glaucoma (0% vs 2.9%), reduced visual acuity (1.9% vs 1.5%), and vitreous hemorrhage (1.0% vs 1.5%). No Antiplatelet Trialists’ Collaboration-defined arterial thromboembolic events occurred during the study.

Conclusions: The visual and anatomic improvements observed at the end of the fixed dosing period were diminished after changing to PRN dosing with a reduced monitoring frequency from Week 52 to 76. IAI was generally well tolerated.

Keywords: 749 vascular occlusion/vascular occlusive disease • 748 vascular endothelial growth factor • 503 drug toxicity/drug effects  
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