Yuichiro Ogura1, Johann Roider2, Jean-François Korobelnik3, Frank G Holz4, Christian Simader5, Ursula Schmidt-Erfurth5, Robert Vitti6, Alyson J Berliner6, Florian Hiemeyer7, Brigitte Stemper8, Oliver Zeitz9, Rupert Sandbrink10. 1. Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Science, Nagoya, Japan. Electronic address: ogura@med.nagoya-cu.ac.jp. 2. Department of Ophthalmology, University of Kiel, Kiel, Germany. 3. Service d'ophtalmologie, Hopital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France. 4. Department of Ophthalmology, University of Bonn, Bonn, Germany. 5. Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. 6. Regeneron Pharmaceuticals, Inc, Tarrytown, New York. 7. Bayer HealthCare AG, Berlin, Germany. 8. Bayer HealthCare AG, Berlin, Germany; Department of Neurology, University of Erlangen-Nürnberg, Germany. 9. Bayer HealthCare AG, Berlin, Germany; Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. 10. Bayer HealthCare AG, Berlin, Germany; Department of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany.
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 < .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 withintravitreal aflibercept.
RCT Entities:
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 < .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: T D Papakostas; L Lim; T van Zyl; J B Miller; B S Modjtahedi; C M Andreoli; D Wu; L H Young; I K Kim; D G Vavvas; D D Esmaili; D Husain; D Eliott; L A Kim Journal: Eye (Lond) Date: 2015-10-09 Impact factor: 3.775
Authors: Philip Hykin; A Toby Prevost; Sobha Sivaprasad; Joana C Vasconcelos; Caroline Murphy; Joanna Kelly; Jayashree Ramu; Abualbishr Alshreef; Laura Flight; Rebekah Pennington; Barry Hounsome; Ellen Lever; Andrew Metry; Edith Poku; Yit Yang; Simon P Harding; Andrew Lotery; Usha Chakravarthy; John Brazier Journal: Health Technol Assess Date: 2021-06 Impact factor: 4.014