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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ERanibizumab, an anti-VEGF antibody fragment that is designed for intraocular use in diabetic retinopathy (DR), led to rapid and sustained improvement in both vision and retinal anatomy, reduced progression of DR, and improved patient-reported function in the RISE and RIDE clinical trials.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERetinal Diseases\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDiabetic retinopathy (DR) is the most common cause of blindness in the working populations of the United States and Europe [Sanchez CI et al. \u003Cem\u003EInvest Ophthalmol Vis Sci\u003C\/em\u003E 2011] and is often accompanied by diabetic macular edema (DME). Ranibizumab (RBZ), an anti-VEGF antibody fragment that is designed for intraocular use in DR, led to rapid and sustained improvement in both vision and retinal anatomy, reduced progression of DR, and improved patient-reported function in two major clinical trials in Latin America and Argentina. David Boyer, MD, Retina-Vitreous Associates Medical Group, Los Angeles, California, USA, presented findings from these trials.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ERISE (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00473330\u0026amp;atom=%2Fspmdc%2F11%2F8%2F15.atom\u0022\u003ENCT00473330\u003C\/a\u003E) and RIDE (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00473382\u0026amp;atom=%2Fspmdc%2F11%2F8%2F15.atom\u0022\u003ENCT00473382\u003C\/a\u003E) were two methodically identical multicenter, randomized, controlled trials for the treatment of DR. The primary endpoint for each double-prospective, double-blind, Phase 3 trial was the proportion of subjects who gained \u226515 standardized eye chart letters (3 lines) in best corrected visual acuity (BCVA) at Month 24. Additional efficacy endpoints included changes in other measures of visual acuity and visual function, changes in retinal anatomy, use of a macular focal\/grid laser, and patient-reported visual function\/quality of life.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EKey inclusion criteria included age \u226518 years with a decrease in vision due primarily to DME; center subfield thickness (CST) \u2265275 \u03bcm; and study eye BCVA of 20\/40 to 20\/320. Key exclusion criteria included use of antiangiogenic drugs in either eye within the 3-month period prior to the start of the study; panretinal photocoagulation, macular laser, intraocular steroids, or surgery in the study eye; cerebral vascular accident or myocardial infarction; active proliferative diabetic retinopathy or uncontrolled glaucoma in the study eye; and HbA1C \u0026gt;12.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatients with loss of vision (BCVA 20\/40 to 20\/320 Snellen equivalent) and DME on retinal imaging were randomized 1:1:1 to receive monthly RBZ (0.5 mg or 0.3 mg) or placebo injections. Subjects were eligible for rescue macular laser, starting at Month 3. Of the placebo patients, 72% received laser versus 33% of RBZ patients. Ocular and systemic adverse events (AEs) were assessed.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ERBZ-treated patients had rapid, sustained, and statistically significant improvements in BCVA and retinal thickness. In both studies, more RBZ-treated patients gained \u226515 letters (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Fewer patients had significant visual acuity (VA) loss of \u226515 letters (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E). More patients had a BCVA Snellen equivalent of 20\/40 or better at Month 24. Also, fewer patients developed additional complications of DR, and AEs were consistent with prior studies of RBZ.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary Endpoint: Proportion of Subjects Gaining \u0026#x2265;15 ETDRS Letters from Baseline to Month 24.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1965544884\u0022 data-figure-caption=\u0022Primary Endpoint: Proportion of Subjects Gaining \u0026#x2265;15 ETDRS Letters from Baseline to Month 24.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12537\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EPrimary Endpoint: Proportion of Subjects Gaining \u226515 ETDRS Letters from Baseline to Month 24.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from S. Boyer, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Proportion of Subjects Losing \u0026#x2265;15 ETDRS Letters from Baseline to Month 24.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1965544884\u0022 data-figure-caption=\u0022Proportion of Subjects Losing \u0026#x2265;15 ETDRS Letters from Baseline to Month 24.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/8\/15\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12538\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EProportion of Subjects Losing \u226515 ETDRS Letters from Baseline to Month 24.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from S. Boyer, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003EDR is the most common microvascular complication of diabetes [Fong DS et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2004] and increases with duration of the disease. Approximately 25% of all type 2 diabetes patients will develop DR [Ciulla TA et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2003]. DME, swelling of the central retina that causes vision loss, occurs in approximately 10% of patients with diabetes. Advanced DR, especially DME, is among the leading causes of blindness in the elderly [Antonetti DA et al. \u003Cem\u003EDiabetes\u003C\/em\u003E 2006].\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ELaser photocoagulation is standard treatment for DME, but vision improvement after treatment is uncommon. Intraocular use of RBZ may represent an important therapeutic advance by improving vision and reducing the severity of retinopathy in DME.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/8\/15.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzn1i1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn1i1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}