1. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion : 18-month results of the phase 3 GALILEO study
- Author
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Yuichiro Ogura, Johann Roider, Jean-François Korobelnik, Frank G. Holz, Christian Simader, Ursula Schmidt-Erfurth, Robert Vitti, Alyson J. Berliner, Florian Hiemeyer, Brigitte Stemper, Oliver Zeitz, Rupert Sandbrink, Mark Gillies, Jennifer Arnold, Ian McAllister, Simon Chen, Paul Mitchell, Lyndell Lim, Ulrich Schoenherr, Siegfried Priglinger, François Devin, Michel Paques, Gabriel Quentel, Michel Weber, Catherine Creuzot-Garcher, Frank Holz, Sabine Aisenbrey, Lutz Lothar Hansen, Peter Wiedemann, Chris Patrick Lohmann, Norbert Pfeiffer, Stefan Dithmar, Dirk Sandner, Bernd Kirchhof, Helmut Sachs, Salvatore Grisanti, Nicolas Feltgen, Karl Heinz Emmerich, Lars-Olaf Hattenbach, Peter Walter, Katrin Engelmann, Norbert Bornfeld, Andreea Gamulescu, Gisbert Richard, Berthold Seitz, Stefan Mennel, Daniel Pauleikhoff, Frank Koch, András Papp, József Ferenc Györy, Ágnes Kerényi, András Seres, András Berta, Lajos Szalczer, Francesco Boscia, Alfonso Giovannini, Ugo Menchini, Frederico Ricci, Monica Varanno, Francesco Viola, Rosangela Lattanzio, Alfredo Reibaldi, Frederico Grignolo, Miki Honda, Hiroko Terasaki, Nagahisa Yoshimura, Mitsuko Yuzawa, Motohiro Kamei, Ilze Zarinova, Guna Laganovska, Ranjana Mathur, Caroline Chee, Dong-Heun Nam, Se-Joon Woo, Young-Hee Yoon, Won-Ki Lee, Hyeong-Gon Yu, Hyoung-Jun Koh, and Bornfeld, Norbert (Beitragende*r)
- Subjects
medicine.medical_specialty ,Visual acuity ,business.industry ,Medizin ,Phases of clinical research ,medicine.disease ,eye diseases ,law.invention ,Ophthalmology ,Central retinal vein occlusion ,Randomized controlled trial ,law ,medicine ,Clinical endpoint ,medicine.symptom ,Prospective cohort study ,business ,Macular edema ,Aflibercept ,medicine.drug - Abstract
Purpose To evaluate intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design 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 P P .001). Mean μm change from baseline central retinal thickness was −448.6 vs −169.3 at week 24 ( P P 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.
- Published
- 2014