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VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study
  1. Frank G Holz1,
  2. Johann Roider2,
  3. Yuichiro Ogura3,
  4. Jean-François Korobelnik4,5,6,
  5. Christian Simader7,
  6. Georg Groetzbach8,
  7. Robert Vitti9,
  8. Alyson J Berliner9,
  9. Florian Hiemeyer8,
  10. Karola Beckmann8,
  11. Oliver Zeitz8,10,
  12. Rupert Sandbrink8,11
  1. 1Department of Ophthalmology, University of Bonn, Bonn, Germany
  2. 2Department of Ophthalmology, University of Kiel, Kiel, Germany
  3. 3Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Science, Nagoya, Japan
  4. 4Service d'ophtalmologie, Hopital Pellegrin—CHU de Bordeaux, Bordeaux, France
  5. 5Université Bordeaux Segalen, Bordeaux, France
  6. 6INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France
  7. 7Department of Ophthalmology, Vienna Reading Center, Medical University of Vienna, Vienna, Austria
  8. 8Bayer HealthCare AG, Berlin, Germany
  9. 9Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA
  10. 10Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
  11. 11Department of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany
  1. Correspondence to Professor Frank G Holz, Department of Ophthalmology, University of Bonn, Ernst-Abbe-Street 2, Bonn 53127, Germany; frank.holz{at}ukb.uni-bonn.de

Abstract

Aim To evaluate intravitreal VEGF Trap-Eye (VTE) in patients with macular oedema secondary to central retinal vein occlusion (CRVO).

Methods In this double-masked study, 177 patients were randomised (3:2 ratio) to intravitreal injections of VTE 2 mg or sham procedure every 4 weeks for 24 weeks. Best-corrected visual acuity was evaluated using the Early Treatment Diabetic Retinopathy Study chart. Central retinal thickness (CRT) was measured with optical coherence tomography.

Results From baseline until week 24, more patients receiving VTE (60.2%) gained ≥15 letters compared with those receiving sham injections (22.1%) (p<0.0001). VTE patients gained a mean of 18.0 letters compared with 3.3 letters with sham injections (p<0.0001). Mean CRT decreased by 448.6 and 169.3 µm in the VTE and sham groups (p<0.0001). The most frequent ocular adverse events in the VTE arm were typically associated with the injection procedure or the underlying disease, and included eye pain (11.5%), increased intraocular pressure (9.6%) and conjunctival haemorrhage (8.7%).

Conclusions VTE 2 mg every 4 weeks was efficacious in CRVO with an acceptable safety profile. Vision gains with VTE were significantly higher than with observation/panretinal photocoagulation if needed. Based on these data, VTE may provide a new treatment option for CRVO.

  • Macula
  • Neovascularisation
  • Retina

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