Integrated results from the COPERNICUS and GALILEO studies
Amelie Pielen,1,2 W Lloyd Clark,3 David S Boyer,4 Yuichiro Ogura,5 Frank G Holz,6 Jean-Francois Korobelnik,7,8 Brigitte Stemper,9,10 Friedrich Asmus,9 Kay D Rittenhouse,11 Christiane Ahlers,9 Robert Vitti,12 Namrata Saroj,12 Oliver Zeitz,9,13,14 Julia A Haller15 On behalf of the COPERNICUS and GALI...
Guardado en:
| Autores principales: | , , , , , , , , , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Dove Medical Press
2017
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/abe61a8dab3843ceb1b6943df25dfc16 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:abe61a8dab3843ceb1b6943df25dfc16 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:abe61a8dab3843ceb1b6943df25dfc162021-12-02T04:54:24ZIntegrated results from the COPERNICUS and GALILEO studies1177-5483https://doaj.org/article/abe61a8dab3843ceb1b6943df25dfc162017-08-01T00:00:00Zhttps://www.dovepress.com/integrated-results-from-the-copernicus-and-galileo-studies-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Amelie Pielen,1,2 W Lloyd Clark,3 David S Boyer,4 Yuichiro Ogura,5 Frank G Holz,6 Jean-Francois Korobelnik,7,8 Brigitte Stemper,9,10 Friedrich Asmus,9 Kay D Rittenhouse,11 Christiane Ahlers,9 Robert Vitti,12 Namrata Saroj,12 Oliver Zeitz,9,13,14 Julia A Haller15 On behalf of the COPERNICUS and GALILEO study group 1Eye Center, University Hospital Freiburg, Eye Hospital, Freiburg, 2Hannover Medical School, University Eye Hospital, Hannover, Germany; 3Palmetto Retina Center, Columbia, SC, USA; 4Retina-Vitreous Associates Medical Group, Beverly Hills, CA, USA; 5Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 6Department of Ophthalmology, University of Bonn, Bonn, Germany; 7Service d’ophtalmologie, CHU de Bordeaux, 8Service d’ophtalmologie, University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team LEHA, UMR 1219, Bordeaux, France; 9Bayer AG, Berlin, 10Department of Neurology, University of Erlangen-Nuremberg, Erlangen, Germany; 11Bayer US LLC, Whippany, NJ, 12Regeneron Pharmaceuticals, Tarrytown, NY, USA; 13AKH Eye Clinic, Braunschweig, 14Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde, Hamburg, Germany; 15Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA Objectives: To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients and methods: Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. Results: At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients. Conclusion: This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO. Keywords: macular edema, central retinal vein occlusion, anti-vascular endothelial growth factor, aflibercept, COPERNICUS, GALILEOPielen AClark WLBoyer DSOgura YHolz FGKorobelnik JFStemper BAsmus FRittenhouse KDAhlers CVitti RSaroj NZeitz OHaller JADove Medical Pressarticlemacular edemacentral retinal vein occlusionanti-vascular endothelial growth factorafliberceptCOPERNICUSGALILEOOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 11, Pp 1533-1540 (2017) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
macular edema central retinal vein occlusion anti-vascular endothelial growth factor aflibercept COPERNICUS GALILEO Ophthalmology RE1-994 |
| spellingShingle |
macular edema central retinal vein occlusion anti-vascular endothelial growth factor aflibercept COPERNICUS GALILEO Ophthalmology RE1-994 Pielen A Clark WL Boyer DS Ogura Y Holz FG Korobelnik JF Stemper B Asmus F Rittenhouse KD Ahlers C Vitti R Saroj N Zeitz O Haller JA Integrated results from the COPERNICUS and GALILEO studies |
| description |
Amelie Pielen,1,2 W Lloyd Clark,3 David S Boyer,4 Yuichiro Ogura,5 Frank G Holz,6 Jean-Francois Korobelnik,7,8 Brigitte Stemper,9,10 Friedrich Asmus,9 Kay D Rittenhouse,11 Christiane Ahlers,9 Robert Vitti,12 Namrata Saroj,12 Oliver Zeitz,9,13,14 Julia A Haller15 On behalf of the COPERNICUS and GALILEO study group 1Eye Center, University Hospital Freiburg, Eye Hospital, Freiburg, 2Hannover Medical School, University Eye Hospital, Hannover, Germany; 3Palmetto Retina Center, Columbia, SC, USA; 4Retina-Vitreous Associates Medical Group, Beverly Hills, CA, USA; 5Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 6Department of Ophthalmology, University of Bonn, Bonn, Germany; 7Service d’ophtalmologie, CHU de Bordeaux, 8Service d’ophtalmologie, University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team LEHA, UMR 1219, Bordeaux, France; 9Bayer AG, Berlin, 10Department of Neurology, University of Erlangen-Nuremberg, Erlangen, Germany; 11Bayer US LLC, Whippany, NJ, 12Regeneron Pharmaceuticals, Tarrytown, NY, USA; 13AKH Eye Clinic, Braunschweig, 14Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde, Hamburg, Germany; 15Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA Objectives: To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients and methods: Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. Results: At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients. Conclusion: This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO. Keywords: macular edema, central retinal vein occlusion, anti-vascular endothelial growth factor, aflibercept, COPERNICUS, GALILEO |
| format |
article |
| author |
Pielen A Clark WL Boyer DS Ogura Y Holz FG Korobelnik JF Stemper B Asmus F Rittenhouse KD Ahlers C Vitti R Saroj N Zeitz O Haller JA |
| author_facet |
Pielen A Clark WL Boyer DS Ogura Y Holz FG Korobelnik JF Stemper B Asmus F Rittenhouse KD Ahlers C Vitti R Saroj N Zeitz O Haller JA |
| author_sort |
Pielen A |
| title |
Integrated results from the COPERNICUS and GALILEO studies |
| title_short |
Integrated results from the COPERNICUS and GALILEO studies |
| title_full |
Integrated results from the COPERNICUS and GALILEO studies |
| title_fullStr |
Integrated results from the COPERNICUS and GALILEO studies |
| title_full_unstemmed |
Integrated results from the COPERNICUS and GALILEO studies |
| title_sort |
integrated results from the copernicus and galileo studies |
| publisher |
Dove Medical Press |
| publishDate |
2017 |
| url |
https://doaj.org/article/abe61a8dab3843ceb1b6943df25dfc16 |
| work_keys_str_mv |
AT pielena integratedresultsfromthecopernicusandgalileostudies AT clarkwl integratedresultsfromthecopernicusandgalileostudies AT boyerds integratedresultsfromthecopernicusandgalileostudies AT oguray integratedresultsfromthecopernicusandgalileostudies AT holzfg integratedresultsfromthecopernicusandgalileostudies AT korobelnikjf integratedresultsfromthecopernicusandgalileostudies AT stemperb integratedresultsfromthecopernicusandgalileostudies AT asmusf integratedresultsfromthecopernicusandgalileostudies AT rittenhousekd integratedresultsfromthecopernicusandgalileostudies AT ahlersc integratedresultsfromthecopernicusandgalileostudies AT vittir integratedresultsfromthecopernicusandgalileostudies AT sarojn integratedresultsfromthecopernicusandgalileostudies AT zeitzo integratedresultsfromthecopernicusandgalileostudies AT hallerja integratedresultsfromthecopernicusandgalileostudies |
| _version_ |
1718401029915017216 |