Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study
To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO). Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial. A total of 397 patients with macular e...
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| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 2010-06, Vol.117 (6), p.1102-1112 |
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| container_title | Ophthalmology (Rochester, Minn.) |
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| creator | CAMPOCHIARO, Peter A HEIER, Jeffrey S FEINER, Leonard GRAY, Sarah SAROJ, Namrata RUNDLE, Amy Chen YEE MURAHASHI, Wendy RUBIO, Roman G |
| description | To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO).
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
A total of 397 patients with macular edema following BRVO.
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections.
The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT).
Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P or =20/40 compared with sham patients (41.7%; P |
| doi_str_mv | 10.1016/j.ophtha.2010.02.021 |
| format | Article |
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Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
A total of 397 patients with macular edema following BRVO.
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections.
The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT).
Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P<0.0001 for each ranibizumab group vs sham). The percentage of patients who gained > or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P<0.0001 for each ranibizumab group vs sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg, 67.9%; 0.5 mg, 64.9%) had BCVA of > or =20/40 compared with sham patients (41.7%; P<0.0001 for each ranibizumab group vs sham); and CFT had decreased by a mean of 337 microm (0.3 mg) and 345 microm (0.5 mg) in the ranibizumab groups and 158 microm in the sham group (P<0.0001 for each ranibizumab group vs sham). The median percent reduction in excess foveal thickness at month 6 was 97.0% and 97.6% in 0.3 mg and 0.5 mg groups and 27.9% in the sham group. More patients in the sham group (54.5%) received rescue grid laser compared with the 0.3 mg (18.7%) and 0.5 mg (19.8%) ranibizumab groups. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with BRVO.
Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid, effective treatment for macular edema following BRVO with low rates of ocular and nonocular safety events.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2010.02.021</identifier><identifier>PMID: 20398941</identifier><identifier>CODEN: OPHTDG</identifier><language>eng</language><publisher>New York, NY: Elsevier</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Angiogenesis Inhibitors - administration & dosage ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal, Humanized ; Biological and medical sciences ; Double-Blind Method ; Endpoint Determination ; Female ; Humans ; Injections ; Laser Coagulation ; Macular Edema - drug therapy ; Macular Edema - etiology ; Macular Edema - physiopathology ; Male ; Medical sciences ; Middle Aged ; Miscellaneous ; Ophthalmology ; Prospective Studies ; Ranibizumab ; Retinal Vein Occlusion - complications ; Retinopathies ; Treatment Outcome ; Vascular Endothelial Growth Factor A - antagonists & inhibitors ; Visual Acuity - physiology ; Vitreous Body</subject><ispartof>Ophthalmology (Rochester, Minn.), 2010-06, Vol.117 (6), p.1102-1112</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22879939$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20398941$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>CAMPOCHIARO, Peter A</creatorcontrib><creatorcontrib>HEIER, Jeffrey S</creatorcontrib><creatorcontrib>FEINER, Leonard</creatorcontrib><creatorcontrib>GRAY, Sarah</creatorcontrib><creatorcontrib>SAROJ, Namrata</creatorcontrib><creatorcontrib>RUNDLE, Amy Chen</creatorcontrib><creatorcontrib>YEE MURAHASHI, Wendy</creatorcontrib><creatorcontrib>RUBIO, Roman G</creatorcontrib><creatorcontrib>BRAVO Investigators</creatorcontrib><title>Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO).
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
A total of 397 patients with macular edema following BRVO.
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections.
The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT).
Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P<0.0001 for each ranibizumab group vs sham). The percentage of patients who gained > or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P<0.0001 for each ranibizumab group vs sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg, 67.9%; 0.5 mg, 64.9%) had BCVA of > or =20/40 compared with sham patients (41.7%; P<0.0001 for each ranibizumab group vs sham); and CFT had decreased by a mean of 337 microm (0.3 mg) and 345 microm (0.5 mg) in the ranibizumab groups and 158 microm in the sham group (P<0.0001 for each ranibizumab group vs sham). The median percent reduction in excess foveal thickness at month 6 was 97.0% and 97.6% in 0.3 mg and 0.5 mg groups and 27.9% in the sham group. More patients in the sham group (54.5%) received rescue grid laser compared with the 0.3 mg (18.7%) and 0.5 mg (19.8%) ranibizumab groups. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with BRVO.
Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid, effective treatment for macular edema following BRVO with low rates of ocular and nonocular safety events.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angiogenesis Inhibitors - administration & dosage</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Biological and medical sciences</subject><subject>Double-Blind Method</subject><subject>Endpoint Determination</subject><subject>Female</subject><subject>Humans</subject><subject>Injections</subject><subject>Laser Coagulation</subject><subject>Macular Edema - drug therapy</subject><subject>Macular Edema - etiology</subject><subject>Macular Edema - physiopathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Ophthalmology</subject><subject>Prospective Studies</subject><subject>Ranibizumab</subject><subject>Retinal Vein Occlusion - complications</subject><subject>Retinopathies</subject><subject>Treatment Outcome</subject><subject>Vascular Endothelial Growth Factor A - antagonists & inhibitors</subject><subject>Visual Acuity - physiology</subject><subject>Vitreous Body</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpF0FlLxDAQB_Agiq7HNxDJi_jUdXL0iG8qqy4ou6zH6zJtUxtJk7Vp8Xjxq1txRRgYGH4zMH9CDhmMGbDk9GXsV3VX45jDMAI-FNsgIxZLFcmUiU0yGhiLEslhh-yG8AIASSLkNtnhIFSmJBuRrwU6k5vPvsGcVr6ld1j0Fls6KXWDw8Ra_2bcM71o0RU1XejOOLT0SRtHZ0Vh-2C8O6P35j26866r6bw1DbYfdOJKOvfGdcNO6G0XqK8o0nmNQdPpdErvu7782CdbFdqgD9Z9jzxeTR4ub6Lb2fX08vw2WnEJXYQFVDzhFUjFtMQ0y6s4YYzxNIMszmQZJ1wPiANKFYtMghK6ylGkiFxAIvbIye_dVetfex26ZWNCoa1Fp30flqkQLOMQy0EerWWfN7pcrn7_Wf5lNoDjNcBQoK1-gjHh3_EsVUoo8Q3vOXv4</recordid><startdate>20100601</startdate><enddate>20100601</enddate><creator>CAMPOCHIARO, Peter A</creator><creator>HEIER, Jeffrey S</creator><creator>FEINER, Leonard</creator><creator>GRAY, Sarah</creator><creator>SAROJ, Namrata</creator><creator>RUNDLE, Amy Chen</creator><creator>YEE MURAHASHI, Wendy</creator><creator>RUBIO, Roman G</creator><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20100601</creationdate><title>Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study</title><author>CAMPOCHIARO, Peter A ; HEIER, Jeffrey S ; FEINER, Leonard ; GRAY, Sarah ; SAROJ, Namrata ; RUNDLE, Amy Chen ; YEE MURAHASHI, Wendy ; RUBIO, Roman G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p240t-ac0f262f0491e4a78bf5611127808584d562eac020a495384093efba37aa23063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Angiogenesis Inhibitors - administration & dosage</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Biological and medical sciences</topic><topic>Double-Blind Method</topic><topic>Endpoint Determination</topic><topic>Female</topic><topic>Humans</topic><topic>Injections</topic><topic>Laser Coagulation</topic><topic>Macular Edema - drug therapy</topic><topic>Macular Edema - etiology</topic><topic>Macular Edema - physiopathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Ophthalmology</topic><topic>Prospective Studies</topic><topic>Ranibizumab</topic><topic>Retinal Vein Occlusion - complications</topic><topic>Retinopathies</topic><topic>Treatment Outcome</topic><topic>Vascular Endothelial Growth Factor A - antagonists & inhibitors</topic><topic>Visual Acuity - physiology</topic><topic>Vitreous Body</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>CAMPOCHIARO, Peter A</creatorcontrib><creatorcontrib>HEIER, Jeffrey S</creatorcontrib><creatorcontrib>FEINER, Leonard</creatorcontrib><creatorcontrib>GRAY, Sarah</creatorcontrib><creatorcontrib>SAROJ, Namrata</creatorcontrib><creatorcontrib>RUNDLE, Amy Chen</creatorcontrib><creatorcontrib>YEE MURAHASHI, Wendy</creatorcontrib><creatorcontrib>RUBIO, Roman G</creatorcontrib><creatorcontrib>BRAVO Investigators</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>CAMPOCHIARO, Peter A</au><au>HEIER, Jeffrey S</au><au>FEINER, Leonard</au><au>GRAY, Sarah</au><au>SAROJ, Namrata</au><au>RUNDLE, Amy Chen</au><au>YEE MURAHASHI, Wendy</au><au>RUBIO, Roman G</au><aucorp>BRAVO Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2010-06-01</date><risdate>2010</risdate><volume>117</volume><issue>6</issue><spage>1102</spage><epage>1112</epage><pages>1102-1112</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><coden>OPHTDG</coden><abstract>To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO).
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
A total of 397 patients with macular edema following BRVO.
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections.
The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT).
Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P<0.0001 for each ranibizumab group vs sham). The percentage of patients who gained > or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P<0.0001 for each ranibizumab group vs sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg, 67.9%; 0.5 mg, 64.9%) had BCVA of > or =20/40 compared with sham patients (41.7%; P<0.0001 for each ranibizumab group vs sham); and CFT had decreased by a mean of 337 microm (0.3 mg) and 345 microm (0.5 mg) in the ranibizumab groups and 158 microm in the sham group (P<0.0001 for each ranibizumab group vs sham). The median percent reduction in excess foveal thickness at month 6 was 97.0% and 97.6% in 0.3 mg and 0.5 mg groups and 27.9% in the sham group. More patients in the sham group (54.5%) received rescue grid laser compared with the 0.3 mg (18.7%) and 0.5 mg (19.8%) ranibizumab groups. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with BRVO.
Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid, effective treatment for macular edema following BRVO with low rates of ocular and nonocular safety events.</abstract><cop>New York, NY</cop><pub>Elsevier</pub><pmid>20398941</pmid><doi>10.1016/j.ophtha.2010.02.021</doi><tpages>11</tpages></addata></record> |
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| ispartof | Ophthalmology (Rochester, Minn.), 2010-06, Vol.117 (6), p.1102-1112 |
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| subjects | Adult Aged Aged, 80 and over Angiogenesis Inhibitors - administration & dosage Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal, Humanized Biological and medical sciences Double-Blind Method Endpoint Determination Female Humans Injections Laser Coagulation Macular Edema - drug therapy Macular Edema - etiology Macular Edema - physiopathology Male Medical sciences Middle Aged Miscellaneous Ophthalmology Prospective Studies Ranibizumab Retinal Vein Occlusion - complications Retinopathies Treatment Outcome Vascular Endothelial Growth Factor A - antagonists & inhibitors Visual Acuity - physiology Vitreous Body |
| title | Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study |
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