Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study

Aims To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting. Methods A 12-month, retrospective, multicenter, observational cohort study, including DME patients wit...

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Veröffentlicht in:Acta diabetologica 2019-07, Vol.56 (7), p.777-784
Hauptverfasser: Busch, Catharina, Fraser-Bell, Samantha, Zur, Dinah, Rodríguez-Valdés, Patricio J., Cebeci, Zafer, Lupidi, Marco, Fung, Adrian T., Gabrielle, Pierre-Henry, Giancipoli, Ermete, Chaikitmongkol, Voraporn, Okada, Mali, Laíns, Inês, Santos, Ana Rita, Kunavisarut, Paradee, Sala-Puigdollers, Anna, Chhablani, Jay, Ozimek, Malgorzata, Hilely, Assaf, Unterlauft, Jan Darius, Loewenstein, Anat, Iglicki, Matias, Rehak, Matus
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container_issue 7
container_start_page 777
container_title Acta diabetologica
container_volume 56
creator Busch, Catharina
Fraser-Bell, Samantha
Zur, Dinah
Rodríguez-Valdés, Patricio J.
Cebeci, Zafer
Lupidi, Marco
Fung, Adrian T.
Gabrielle, Pierre-Henry
Giancipoli, Ermete
Chaikitmongkol, Voraporn
Okada, Mali
Laíns, Inês
Santos, Ana Rita
Kunavisarut, Paradee
Sala-Puigdollers, Anna
Chhablani, Jay
Ozimek, Malgorzata
Hilely, Assaf
Unterlauft, Jan Darius
Loewenstein, Anat
Iglicki, Matias
Rehak, Matus
description Aims To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting. Methods A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) > 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography. Results A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss 
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Methods A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) &gt; 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography. Results A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss &lt; 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (− 4.2 vs. − 7.8 letters, p  = 0.013). In eyes in which treatment was initiated at baseline ( n  = 102), treatment with 8–12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (− 0.3 ± 3.6 letters vs. − 3.8 ± 6.2 letters, p  = 0.003). Conclusion In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.</description><identifier>ISSN: 0940-5429</identifier><identifier>EISSN: 1432-5233</identifier><identifier>DOI: 10.1007/s00592-019-01310-z</identifier><identifier>PMID: 30903434</identifier><language>eng</language><publisher>Milan: Springer Milan</publisher><subject>Acuity ; Diabetes ; Diabetes mellitus ; Edema ; Endocrinology and metabolism ; Eye ; Human health and pathology ; Internal Medicine ; Life Sciences ; Medicine ; Medicine &amp; Public Health ; Metabolic Diseases ; Original ; Original Article ; Patients ; Vascular endothelial growth factor ; Vision ; Visual acuity</subject><ispartof>Acta diabetologica, 2019-07, Vol.56 (7), p.777-784</ispartof><rights>The Author(s) 2019</rights><rights>Acta Diabetologica is a copyright of Springer, (2019). All Rights Reserved. © 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). 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Methods A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) &gt; 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography. Results A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss &lt; 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (− 4.2 vs. − 7.8 letters, p  = 0.013). In eyes in which treatment was initiated at baseline ( n  = 102), treatment with 8–12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (− 0.3 ± 3.6 letters vs. − 3.8 ± 6.2 letters, p  = 0.003). Conclusion In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.</description><subject>Acuity</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Edema</subject><subject>Endocrinology and metabolism</subject><subject>Eye</subject><subject>Human health and pathology</subject><subject>Internal Medicine</subject><subject>Life Sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Metabolic Diseases</subject><subject>Original</subject><subject>Original Article</subject><subject>Patients</subject><subject>Vascular endothelial growth factor</subject><subject>Vision</subject><subject>Visual acuity</subject><issn>0940-5429</issn><issn>1432-5233</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><recordid>eNp9kk9v1DAQxS0EosvCF-CALHGBQ2D8L4k5IC0V0EorKqFythzH2XWVxMV2tko_PS4pBXrowbLk-c2b8dND6CWBdwSgeh8BhKQFEJkPI1BcP0IrwhktBGXsMVqB5FAITuURehbjBQChFaufoiMGEhhnfIXm71b3xZUPfYv9lIwfbMS-w76JNhx0cn7EemxxClanwY4JuxG3Tjc2OYMHbaZeB2xbO2h85dIeH2yY8c77Fh9cnHSPM-LS_AGnvcVnn843p99wTFM7P0dPOt1H--L2XqMfXz6fH58U27Ovp8ebbWFEKVLR0Jroqsyrt52kEgwzlaw7brRpuDSspJ0xpBYVJ8Y2uhGy6Qiva8OF7BpgbI0-LrqXUzPY1uQ_BN2ry-AGHWbltVP_V0a3Vzt_UKUQNWQn1-jtIrC_13ay2aqbN6AlFUySA8nsm9thwf-cbExqcNHYvtej9VNUlMgyS9ZlmdHX99ALP4UxW6FoJoCKWpAHKSLzr2l2KVN0oUzwMQbb3e1JQN1kRS1ZUTkr6ndW1HVuevWvMXctf8KRAbYAMZfGnQ1_Zz8g-ws98cpo</recordid><startdate>20190701</startdate><enddate>20190701</enddate><creator>Busch, Catharina</creator><creator>Fraser-Bell, Samantha</creator><creator>Zur, Dinah</creator><creator>Rodríguez-Valdés, Patricio J.</creator><creator>Cebeci, Zafer</creator><creator>Lupidi, Marco</creator><creator>Fung, Adrian T.</creator><creator>Gabrielle, Pierre-Henry</creator><creator>Giancipoli, Ermete</creator><creator>Chaikitmongkol, Voraporn</creator><creator>Okada, Mali</creator><creator>Laíns, Inês</creator><creator>Santos, Ana Rita</creator><creator>Kunavisarut, Paradee</creator><creator>Sala-Puigdollers, Anna</creator><creator>Chhablani, Jay</creator><creator>Ozimek, Malgorzata</creator><creator>Hilely, Assaf</creator><creator>Unterlauft, Jan Darius</creator><creator>Loewenstein, Anat</creator><creator>Iglicki, Matias</creator><creator>Rehak, Matus</creator><general>Springer Milan</general><general>Springer Nature B.V</general><general>Springer Verlag</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6267-4663</orcidid></search><sort><creationdate>20190701</creationdate><title>Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study</title><author>Busch, Catharina ; Fraser-Bell, Samantha ; Zur, Dinah ; Rodríguez-Valdés, Patricio J. ; Cebeci, Zafer ; Lupidi, Marco ; Fung, Adrian T. ; Gabrielle, Pierre-Henry ; Giancipoli, Ermete ; Chaikitmongkol, Voraporn ; Okada, Mali ; Laíns, Inês ; Santos, Ana Rita ; Kunavisarut, Paradee ; Sala-Puigdollers, Anna ; Chhablani, Jay ; Ozimek, Malgorzata ; Hilely, Assaf ; Unterlauft, Jan Darius ; Loewenstein, Anat ; Iglicki, Matias ; Rehak, Matus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c565t-b281a76012df9290c3c798f4cacb49c362fcc185741cebab59bf1488c459fb033</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Acuity</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Edema</topic><topic>Endocrinology and metabolism</topic><topic>Eye</topic><topic>Human health and pathology</topic><topic>Internal Medicine</topic><topic>Life Sciences</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Metabolic Diseases</topic><topic>Original</topic><topic>Original Article</topic><topic>Patients</topic><topic>Vascular endothelial growth factor</topic><topic>Vision</topic><topic>Visual acuity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Busch, Catharina</creatorcontrib><creatorcontrib>Fraser-Bell, Samantha</creatorcontrib><creatorcontrib>Zur, Dinah</creatorcontrib><creatorcontrib>Rodríguez-Valdés, Patricio J.</creatorcontrib><creatorcontrib>Cebeci, Zafer</creatorcontrib><creatorcontrib>Lupidi, Marco</creatorcontrib><creatorcontrib>Fung, Adrian T.</creatorcontrib><creatorcontrib>Gabrielle, Pierre-Henry</creatorcontrib><creatorcontrib>Giancipoli, Ermete</creatorcontrib><creatorcontrib>Chaikitmongkol, Voraporn</creatorcontrib><creatorcontrib>Okada, Mali</creatorcontrib><creatorcontrib>Laíns, Inês</creatorcontrib><creatorcontrib>Santos, Ana Rita</creatorcontrib><creatorcontrib>Kunavisarut, Paradee</creatorcontrib><creatorcontrib>Sala-Puigdollers, Anna</creatorcontrib><creatorcontrib>Chhablani, Jay</creatorcontrib><creatorcontrib>Ozimek, Malgorzata</creatorcontrib><creatorcontrib>Hilely, Assaf</creatorcontrib><creatorcontrib>Unterlauft, Jan Darius</creatorcontrib><creatorcontrib>Loewenstein, Anat</creatorcontrib><creatorcontrib>Iglicki, Matias</creatorcontrib><creatorcontrib>Rehak, Matus</creatorcontrib><creatorcontrib>International Retina Group</creatorcontrib><creatorcontrib>For the International Retina Group</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Acta diabetologica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Busch, Catharina</au><au>Fraser-Bell, Samantha</au><au>Zur, Dinah</au><au>Rodríguez-Valdés, Patricio J.</au><au>Cebeci, Zafer</au><au>Lupidi, Marco</au><au>Fung, Adrian T.</au><au>Gabrielle, Pierre-Henry</au><au>Giancipoli, Ermete</au><au>Chaikitmongkol, Voraporn</au><au>Okada, Mali</au><au>Laíns, Inês</au><au>Santos, Ana Rita</au><au>Kunavisarut, Paradee</au><au>Sala-Puigdollers, Anna</au><au>Chhablani, Jay</au><au>Ozimek, Malgorzata</au><au>Hilely, Assaf</au><au>Unterlauft, Jan Darius</au><au>Loewenstein, Anat</au><au>Iglicki, Matias</au><au>Rehak, Matus</au><aucorp>International Retina Group</aucorp><aucorp>For the International Retina Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study</atitle><jtitle>Acta diabetologica</jtitle><stitle>Acta Diabetol</stitle><addtitle>Acta Diabetol</addtitle><date>2019-07-01</date><risdate>2019</risdate><volume>56</volume><issue>7</issue><spage>777</spage><epage>784</epage><pages>777-784</pages><issn>0940-5429</issn><eissn>1432-5233</eissn><abstract>Aims To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting. Methods A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) &gt; 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography. Results A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss &lt; 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (− 4.2 vs. − 7.8 letters, p  = 0.013). In eyes in which treatment was initiated at baseline ( n  = 102), treatment with 8–12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (− 0.3 ± 3.6 letters vs. − 3.8 ± 6.2 letters, p  = 0.003). Conclusion In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.</abstract><cop>Milan</cop><pub>Springer Milan</pub><pmid>30903434</pmid><doi>10.1007/s00592-019-01310-z</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-6267-4663</orcidid><oa>free_for_read</oa></addata></record>
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subjects Acuity
Diabetes
Diabetes mellitus
Edema
Endocrinology and metabolism
Eye
Human health and pathology
Internal Medicine
Life Sciences
Medicine
Medicine & Public Health
Metabolic Diseases
Original
Original Article
Patients
Vascular endothelial growth factor
Vision
Visual acuity
title Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study
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