Intravitreal aflibercept for submacular hemorrhage secondary to neovascular age-related macular degeneration and polypoidal choroidal vasculopathy

Purpose To evaluate the efficacy of intravitreal aflibercept monotherapy for submacular hemorrhage secondary to neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV). Methods This prospective, phase 4 clinical trial included 29 patients diagnosed with fovea-i...

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Veröffentlicht in:Graefe's archive for clinical and experimental ophthalmology 2020, Vol.258 (1), p.107-116
Hauptverfasser: Kim, Jae Hui, Kim, Chul Gu, Lee, Dong Won, Yoo, Su Jin, Lew, Young Ju, Cho, Han Joo, Kim, Joo Yeon, Lee, Seok Hyun, Kim, Jong Woo
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container_title Graefe's archive for clinical and experimental ophthalmology
container_volume 258
creator Kim, Jae Hui
Kim, Chul Gu
Lee, Dong Won
Yoo, Su Jin
Lew, Young Ju
Cho, Han Joo
Kim, Joo Yeon
Lee, Seok Hyun
Kim, Jong Woo
description Purpose To evaluate the efficacy of intravitreal aflibercept monotherapy for submacular hemorrhage secondary to neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV). Methods This prospective, phase 4 clinical trial included 29 patients diagnosed with fovea-involving submacular hemorrhage secondary to neovascular AMD (7 patients) or PCV (22 patients). Patients were initially administered 3 monthly aflibercept injections, followed by 1 injection every 2 months. The primary outcome measure was changes in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) during the 56-week study period. Other key outcome measures were the proportion of patients who exhibited changes in BCVA of ≥ 15 ETDRS letters from baseline and changes in central retinal thickness (CRT). Results The mean size of hemorrhage was 6.2 ± 4.8-disc-diameter area. The mean BCVA significantly improved from 52.9 ± 17.8 ETDRS letters at week 0 (baseline) to 71.8 ± 16.1 letters at week 56 ( P  
doi_str_mv 10.1007/s00417-019-04474-0
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Methods This prospective, phase 4 clinical trial included 29 patients diagnosed with fovea-involving submacular hemorrhage secondary to neovascular AMD (7 patients) or PCV (22 patients). Patients were initially administered 3 monthly aflibercept injections, followed by 1 injection every 2 months. The primary outcome measure was changes in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) during the 56-week study period. Other key outcome measures were the proportion of patients who exhibited changes in BCVA of ≥ 15 ETDRS letters from baseline and changes in central retinal thickness (CRT). Results The mean size of hemorrhage was 6.2 ± 4.8-disc-diameter area. The mean BCVA significantly improved from 52.9 ± 17.8 ETDRS letters at week 0 (baseline) to 71.8 ± 16.1 letters at week 56 ( P  &lt; 0.001). At week 56, improvement in BCVA of ≥ 15 letters was noted in 16 patients (55.2%), whereas none of the patients experienced a loss of ≥ 15 letters. The mean CRT significantly decreased from 498.9 ± 194.2 μm at week 0 to 248.3 ± 45.0 μm at week 56 ( P  &lt; 0.001). During the study period, retinal break developed in one patient. Conclusions Intravitreal aflibercept administered every 2 months after the 3 initial monthly doses was found to be an effective and safe treatment method for submacular hemorrhage secondary to neovascular AMD.</description><identifier>ISSN: 0721-832X</identifier><identifier>EISSN: 1435-702X</identifier><identifier>DOI: 10.1007/s00417-019-04474-0</identifier><identifier>PMID: 31741044</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Acuity ; Age ; Diabetes mellitus ; Diabetic retinopathy ; Eye ; Hemorrhage ; Macular degeneration ; Medicine ; Medicine &amp; Public Health ; Ophthalmology ; Patients ; Retina ; Retinal Disorders ; Retinopathy ; Vascular diseases</subject><ispartof>Graefe's archive for clinical and experimental ophthalmology, 2020, Vol.258 (1), p.107-116</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>Graefe's Archive for Clinical and Experimental Ophthalmology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-p213t-ecdb6388a885033eefba8830f77918b0fcdb6e65056a14b355865fcf74a7439b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00417-019-04474-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00417-019-04474-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31741044$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Jae Hui</creatorcontrib><creatorcontrib>Kim, Chul Gu</creatorcontrib><creatorcontrib>Lee, Dong Won</creatorcontrib><creatorcontrib>Yoo, Su Jin</creatorcontrib><creatorcontrib>Lew, Young Ju</creatorcontrib><creatorcontrib>Cho, Han Joo</creatorcontrib><creatorcontrib>Kim, Joo Yeon</creatorcontrib><creatorcontrib>Lee, Seok Hyun</creatorcontrib><creatorcontrib>Kim, Jong Woo</creatorcontrib><title>Intravitreal aflibercept for submacular hemorrhage secondary to neovascular age-related macular degeneration and polypoidal choroidal vasculopathy</title><title>Graefe's archive for clinical and experimental ophthalmology</title><addtitle>Graefes Arch Clin Exp Ophthalmol</addtitle><addtitle>Graefes Arch Clin Exp Ophthalmol</addtitle><description>Purpose To evaluate the efficacy of intravitreal aflibercept monotherapy for submacular hemorrhage secondary to neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV). Methods This prospective, phase 4 clinical trial included 29 patients diagnosed with fovea-involving submacular hemorrhage secondary to neovascular AMD (7 patients) or PCV (22 patients). Patients were initially administered 3 monthly aflibercept injections, followed by 1 injection every 2 months. The primary outcome measure was changes in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) during the 56-week study period. Other key outcome measures were the proportion of patients who exhibited changes in BCVA of ≥ 15 ETDRS letters from baseline and changes in central retinal thickness (CRT). Results The mean size of hemorrhage was 6.2 ± 4.8-disc-diameter area. The mean BCVA significantly improved from 52.9 ± 17.8 ETDRS letters at week 0 (baseline) to 71.8 ± 16.1 letters at week 56 ( P  &lt; 0.001). At week 56, improvement in BCVA of ≥ 15 letters was noted in 16 patients (55.2%), whereas none of the patients experienced a loss of ≥ 15 letters. The mean CRT significantly decreased from 498.9 ± 194.2 μm at week 0 to 248.3 ± 45.0 μm at week 56 ( P  &lt; 0.001). During the study period, retinal break developed in one patient. Conclusions Intravitreal aflibercept administered every 2 months after the 3 initial monthly doses was found to be an effective and safe treatment method for submacular hemorrhage secondary to neovascular AMD.</description><subject>Acuity</subject><subject>Age</subject><subject>Diabetes mellitus</subject><subject>Diabetic retinopathy</subject><subject>Eye</subject><subject>Hemorrhage</subject><subject>Macular degeneration</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Ophthalmology</subject><subject>Patients</subject><subject>Retina</subject><subject>Retinal Disorders</subject><subject>Retinopathy</subject><subject>Vascular diseases</subject><issn>0721-832X</issn><issn>1435-702X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNpdkc1O3DAUhS1UBMPPC3RRWeqmG5fr2I4zywpRQEJiAxI76ya5mQnKxKntIM1r9IlrCAipK1_pfPfYPoexrxJ-SgB7EQG0tALkWoDWVgs4YCuplREWiqcvbAW2kKJSxdMxO4nxGTKvjDxix0paLfPOiv29HVPAlz4FwoFjN_Q1hYamxDsfeJzrHTbzgIFvaedD2OKGeKTGjy2GPU-ej-RfMC5MFkWgARO1_GOvpQ2NFDD1fuQ4tnzyw37yfZuva7Y-LNNi4SdM2_0ZO-xwiHT-fp6yx99XD5c34u7--vby152YCqmSoKatS1VVWFUGlCLq6jwq6Kxdy6qG7lWn0oApUepaGVOVpms6q9Fqta7VKfux-E7B_5kpJrfrY0PDgPlPc3SFkmZtQRWQ0e__oc9-DmN-XaZymJWypczUt3cqx0atm0K_yym5j7QzoBYgZmncUPi0keBeO3VLpy536t46daD-AfU7laY</recordid><startdate>2020</startdate><enddate>2020</enddate><creator>Kim, Jae Hui</creator><creator>Kim, Chul Gu</creator><creator>Lee, Dong Won</creator><creator>Yoo, Su Jin</creator><creator>Lew, Young Ju</creator><creator>Cho, Han Joo</creator><creator>Kim, Joo Yeon</creator><creator>Lee, Seok Hyun</creator><creator>Kim, Jong Woo</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>2020</creationdate><title>Intravitreal aflibercept for submacular hemorrhage secondary to neovascular age-related macular degeneration and polypoidal choroidal vasculopathy</title><author>Kim, Jae Hui ; Kim, Chul Gu ; Lee, Dong Won ; Yoo, Su Jin ; Lew, Young Ju ; Cho, Han Joo ; Kim, Joo Yeon ; Lee, Seok Hyun ; Kim, Jong Woo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p213t-ecdb6388a885033eefba8830f77918b0fcdb6e65056a14b355865fcf74a7439b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Acuity</topic><topic>Age</topic><topic>Diabetes mellitus</topic><topic>Diabetic retinopathy</topic><topic>Eye</topic><topic>Hemorrhage</topic><topic>Macular degeneration</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Ophthalmology</topic><topic>Patients</topic><topic>Retina</topic><topic>Retinal Disorders</topic><topic>Retinopathy</topic><topic>Vascular diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Jae Hui</creatorcontrib><creatorcontrib>Kim, Chul Gu</creatorcontrib><creatorcontrib>Lee, Dong Won</creatorcontrib><creatorcontrib>Yoo, Su Jin</creatorcontrib><creatorcontrib>Lew, Young Ju</creatorcontrib><creatorcontrib>Cho, Han Joo</creatorcontrib><creatorcontrib>Kim, Joo Yeon</creatorcontrib><creatorcontrib>Lee, Seok Hyun</creatorcontrib><creatorcontrib>Kim, Jong Woo</creatorcontrib><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health &amp; 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Methods This prospective, phase 4 clinical trial included 29 patients diagnosed with fovea-involving submacular hemorrhage secondary to neovascular AMD (7 patients) or PCV (22 patients). Patients were initially administered 3 monthly aflibercept injections, followed by 1 injection every 2 months. The primary outcome measure was changes in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) during the 56-week study period. Other key outcome measures were the proportion of patients who exhibited changes in BCVA of ≥ 15 ETDRS letters from baseline and changes in central retinal thickness (CRT). Results The mean size of hemorrhage was 6.2 ± 4.8-disc-diameter area. The mean BCVA significantly improved from 52.9 ± 17.8 ETDRS letters at week 0 (baseline) to 71.8 ± 16.1 letters at week 56 ( P  &lt; 0.001). At week 56, improvement in BCVA of ≥ 15 letters was noted in 16 patients (55.2%), whereas none of the patients experienced a loss of ≥ 15 letters. The mean CRT significantly decreased from 498.9 ± 194.2 μm at week 0 to 248.3 ± 45.0 μm at week 56 ( P  &lt; 0.001). During the study period, retinal break developed in one patient. Conclusions Intravitreal aflibercept administered every 2 months after the 3 initial monthly doses was found to be an effective and safe treatment method for submacular hemorrhage secondary to neovascular AMD.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31741044</pmid><doi>10.1007/s00417-019-04474-0</doi><tpages>10</tpages></addata></record>
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subjects Acuity
Age
Diabetes mellitus
Diabetic retinopathy
Eye
Hemorrhage
Macular degeneration
Medicine
Medicine & Public Health
Ophthalmology
Patients
Retina
Retinal Disorders
Retinopathy
Vascular diseases
title Intravitreal aflibercept for submacular hemorrhage secondary to neovascular age-related macular degeneration and polypoidal choroidal vasculopathy
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