title: Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study.
abstract: OBJECTIVE
  To evaluate intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion (CRVO).
  
  
  METHODS
  Randomized, double-masked, phase 3 study.
  
  
  METHODS
  A total of 177 patients with macular edema secondary to CRVO were randomized to receive 2 mg intravitreal aflibercept (n = 106) or sham (n = 71) every 4 weeks for 20 weeks. From weeks 24 to 48, patients were monitored every 4 weeks; the former group received intravitreal aflibercept as needed (PRN), and the sham group received sham. From weeks 52 to 76, patients were monitored every 8 weeks, and both groups received intravitreal aflibercept PRN. The primary endpoint (proportion of patients who gained ≥15 letters) was at week 24. This study reports exploratory outcomes at week 76.
  
  
  RESULTS
  The proportion of patients who gained ≥15 letters in the intravitreal aflibercept and sham groups was 60.2% vs 22.1% at week 24 (patients discontinued before week 24 were considered nonresponders; P < .0001), 60.2% vs 32.4% at week 52 (last observation carried forward, P < .001), and 57.3% vs 29.4% at week 76 (last observation carried forward; P < .001). Mean μm change from baseline central retinal thickness was -448.6 vs -169.3 at week 24 (P < .0001), -423.5 vs -219.3 at week 52 (P < .0001), and -389.4 vs -306.4 at week 76 (P = .1122). Over 76 weeks, the most common ocular serious adverse event in the intravitreal aflibercept group was macular edema (3.8%).
  
  
  CONCLUSIONS
  The visual and anatomic improvements seen after fixed, monthly dosing at week 24 were largely maintained when treatment intervals were extended. Patients with macular edema following CRVO benefited from early treatment with intravitreal aflibercept.
authors: Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Science, Nagoya, Japan. Electronic address: ogura@med.nagoya-cu.ac.jp.
authors: Yuichiro
authors: Y
authors: Ogura
authors: Department of Ophthalmology, University of Kiel, Kiel, Germany.
authors: Johann
authors: J
authors: Roider
authors: Service d'ophtalmologie, Hopital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France.
authors: Jean-François
authors: JF
authors: Korobelnik
authors: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors: Frank G
authors: FG
authors: Holz
authors: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors: Christian
authors: C
authors: Simader
authors: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
authors: Ursula
authors: U
authors: Schmidt-Erfurth
authors: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors: Robert
authors: R
authors: Vitti
authors: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors: Alyson J
authors: AJ
authors: Berliner
authors: Bayer HealthCare AG, Berlin, Germany.
authors: Florian
authors: F
authors: Hiemeyer
authors: Bayer HealthCare AG, Berlin, Germany; Department of Neurology, University of Erlangen-Nürnberg, Germany.
authors: Brigitte
authors: B
authors: Stemper
authors: Bayer HealthCare AG, Berlin, Germany; Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
authors: Oliver
authors: O
authors: Zeitz
authors: Bayer HealthCare AG, Berlin, Germany; Department of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany.
authors: Rupert
authors: R
authors: Sandbrink
mesh_terms: D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage*; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D012170:Retinal Vein Occlusion / Q000150:complications* / Q000175:diagnosis; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor