Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study
To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME). Prospective, randomized, interventional, multicenter clinical trial. A total of 126 patients with DME. Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, a...
Gespeichert in:
| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 2009-11, Vol.116 (11), p.2175-2181 |
|---|---|
| Hauptverfasser: | , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 2181 |
|---|---|
| container_issue | 11 |
| container_start_page | 2175 |
| container_title | Ophthalmology (Rochester, Minn.) |
| container_volume | 116 |
| creator | QUAN DONG NGUYEN SHAH, Syed-Mahmood HEIER, Jeffery S DO, Diana V LIM, Jennifer BOYER, David ABRAHAM, Prema CAMPOCHIARO, Peter A |
| description | To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).
Prospective, randomized, interventional, multicenter clinical trial.
A total of 126 patients with DME.
Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).
The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.
At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.
During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME. |
| doi_str_mv | 10.1016/j.ophtha.2009.04.023 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_66634603</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>66634603</sourcerecordid><originalsourceid>FETCH-LOGICAL-c401t-8d153a8fbd0abb9c7938b8fd23d859f3e18eea0dce6d544853e1ce7f095765293</originalsourceid><addsrcrecordid>eNpFkElLK0EUhQtRNA7_QKQ2ii66vTX0UMsQ894TFCXquqiugVToIXZVg_rr7ZDoW1049ztn8SF0TiAlQPLbVdqtl3GpUgogUuApULaHJiTjIuEFYftoMmIkyTmFI3QcwgoA8pzxQ3RERAFABJ-g-rn3jeo_8bw1-LnzbcTXL_4DP3ZtXIYbvLBhqGPAncNxafFCtb7yX0OjKuy6Hs-NbdTPs5nqoVbYt_jOq8pGG_D1Yj69S-gNfomD-TxFB07VwZ7t7gl6-zN_nf1LHp7-3s-mD4nmQGJSGpIxVbrKgKoqoQvByqp0hjJTZsIxS0prFRhtc5NxXmZjom3hQGRFnlHBTtDVdnfdd--DDVE2Pmhb16q13RBkvtGQAxtBvgV134XQWyfXWx2SgNxYliu5tSw3liVwOVoeaxe7_aFqrPlf2mkdgcsdoIJWtetVq3345SgllLOMs2-IF4Xk</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>66634603</pqid></control><display><type>article</type><title>Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>QUAN DONG NGUYEN ; SHAH, Syed-Mahmood ; HEIER, Jeffery S ; DO, Diana V ; LIM, Jennifer ; BOYER, David ; ABRAHAM, Prema ; CAMPOCHIARO, Peter A</creator><creatorcontrib>QUAN DONG NGUYEN ; SHAH, Syed-Mahmood ; HEIER, Jeffery S ; DO, Diana V ; LIM, Jennifer ; BOYER, David ; ABRAHAM, Prema ; CAMPOCHIARO, Peter A ; READ-2 Study Group</creatorcontrib><description>To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).
Prospective, randomized, interventional, multicenter clinical trial.
A total of 126 patients with DME.
Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).
The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.
At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.
During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2009.04.023</identifier><identifier>PMID: 19700194</identifier><identifier>CODEN: OPHTDG</identifier><language>eng</language><publisher>New York, NY: Elsevier</publisher><subject>Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal, Humanized ; Biological and medical sciences ; Combined Modality Therapy ; Diabetes. Impaired glucose tolerance ; Diabetic Retinopathy - drug therapy ; Diabetic Retinopathy - physiopathology ; Diabetic Retinopathy - surgery ; Diabetic Retinopathy - therapy ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Endpoint Determination ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Female ; Humans ; Injections ; Laser Coagulation ; Macular Edema - drug therapy ; Macular Edema - physiopathology ; Macular Edema - surgery ; Macular Edema - therapy ; Male ; Medical sciences ; Middle Aged ; Miscellaneous ; Ophthalmology ; Prospective Studies ; Ranibizumab ; Tomography, Optical Coherence ; Treatment Outcome ; Visual Acuity - physiology ; Vitreous Body</subject><ispartof>Ophthalmology (Rochester, Minn.), 2009-11, Vol.116 (11), p.2175-2181</ispartof><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c401t-8d153a8fbd0abb9c7938b8fd23d859f3e18eea0dce6d544853e1ce7f095765293</citedby></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=22124354$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19700194$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>QUAN DONG NGUYEN</creatorcontrib><creatorcontrib>SHAH, Syed-Mahmood</creatorcontrib><creatorcontrib>HEIER, Jeffery S</creatorcontrib><creatorcontrib>DO, Diana V</creatorcontrib><creatorcontrib>LIM, Jennifer</creatorcontrib><creatorcontrib>BOYER, David</creatorcontrib><creatorcontrib>ABRAHAM, Prema</creatorcontrib><creatorcontrib>CAMPOCHIARO, Peter A</creatorcontrib><creatorcontrib>READ-2 Study Group</creatorcontrib><title>Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).
Prospective, randomized, interventional, multicenter clinical trial.
A total of 126 patients with DME.
Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).
The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.
At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.
During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME.</description><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Biological and medical sciences</subject><subject>Combined Modality Therapy</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Diabetic Retinopathy - drug therapy</subject><subject>Diabetic Retinopathy - physiopathology</subject><subject>Diabetic Retinopathy - surgery</subject><subject>Diabetic Retinopathy - therapy</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Endpoint Determination</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Female</subject><subject>Humans</subject><subject>Injections</subject><subject>Laser Coagulation</subject><subject>Macular Edema - drug therapy</subject><subject>Macular Edema - physiopathology</subject><subject>Macular Edema - surgery</subject><subject>Macular Edema - therapy</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>Tomography, Optical Coherence</subject><subject>Treatment Outcome</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>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkElLK0EUhQtRNA7_QKQ2ii66vTX0UMsQ894TFCXquqiugVToIXZVg_rr7ZDoW1049ztn8SF0TiAlQPLbVdqtl3GpUgogUuApULaHJiTjIuEFYftoMmIkyTmFI3QcwgoA8pzxQ3RERAFABJ-g-rn3jeo_8bw1-LnzbcTXL_4DP3ZtXIYbvLBhqGPAncNxafFCtb7yX0OjKuy6Hs-NbdTPs5nqoVbYt_jOq8pGG_D1Yj69S-gNfomD-TxFB07VwZ7t7gl6-zN_nf1LHp7-3s-mD4nmQGJSGpIxVbrKgKoqoQvByqp0hjJTZsIxS0prFRhtc5NxXmZjom3hQGRFnlHBTtDVdnfdd--DDVE2Pmhb16q13RBkvtGQAxtBvgV134XQWyfXWx2SgNxYliu5tSw3liVwOVoeaxe7_aFqrPlf2mkdgcsdoIJWtetVq3345SgllLOMs2-IF4Xk</recordid><startdate>20091101</startdate><enddate>20091101</enddate><creator>QUAN DONG NGUYEN</creator><creator>SHAH, Syed-Mahmood</creator><creator>HEIER, Jeffery S</creator><creator>DO, Diana V</creator><creator>LIM, Jennifer</creator><creator>BOYER, David</creator><creator>ABRAHAM, Prema</creator><creator>CAMPOCHIARO, Peter A</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>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20091101</creationdate><title>Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study</title><author>QUAN DONG NGUYEN ; SHAH, Syed-Mahmood ; HEIER, Jeffery S ; DO, Diana V ; LIM, Jennifer ; BOYER, David ; ABRAHAM, Prema ; CAMPOCHIARO, Peter A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c401t-8d153a8fbd0abb9c7938b8fd23d859f3e18eea0dce6d544853e1ce7f095765293</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Biological and medical sciences</topic><topic>Combined Modality Therapy</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Diabetic Retinopathy - drug therapy</topic><topic>Diabetic Retinopathy - physiopathology</topic><topic>Diabetic Retinopathy - surgery</topic><topic>Diabetic Retinopathy - therapy</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Endpoint Determination</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Female</topic><topic>Humans</topic><topic>Injections</topic><topic>Laser Coagulation</topic><topic>Macular Edema - drug therapy</topic><topic>Macular Edema - physiopathology</topic><topic>Macular Edema - surgery</topic><topic>Macular Edema - therapy</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>Tomography, Optical Coherence</topic><topic>Treatment Outcome</topic><topic>Visual Acuity - physiology</topic><topic>Vitreous Body</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>QUAN DONG NGUYEN</creatorcontrib><creatorcontrib>SHAH, Syed-Mahmood</creatorcontrib><creatorcontrib>HEIER, Jeffery S</creatorcontrib><creatorcontrib>DO, Diana V</creatorcontrib><creatorcontrib>LIM, Jennifer</creatorcontrib><creatorcontrib>BOYER, David</creatorcontrib><creatorcontrib>ABRAHAM, Prema</creatorcontrib><creatorcontrib>CAMPOCHIARO, Peter A</creatorcontrib><creatorcontrib>READ-2 Study Group</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>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>QUAN DONG NGUYEN</au><au>SHAH, Syed-Mahmood</au><au>HEIER, Jeffery S</au><au>DO, Diana V</au><au>LIM, Jennifer</au><au>BOYER, David</au><au>ABRAHAM, Prema</au><au>CAMPOCHIARO, Peter A</au><aucorp>READ-2 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2009-11-01</date><risdate>2009</risdate><volume>116</volume><issue>11</issue><spage>2175</spage><epage>2181</epage><pages>2175-2181</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><coden>OPHTDG</coden><abstract>To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).
Prospective, randomized, interventional, multicenter clinical trial.
A total of 126 patients with DME.
Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).
The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.
At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.
During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME.</abstract><cop>New York, NY</cop><pub>Elsevier</pub><pmid>19700194</pmid><doi>10.1016/j.ophtha.2009.04.023</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0161-6420 |
| ispartof | Ophthalmology (Rochester, Minn.), 2009-11, Vol.116 (11), p.2175-2181 |
| issn | 0161-6420 1549-4713 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_66634603 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal, Humanized Biological and medical sciences Combined Modality Therapy Diabetes. Impaired glucose tolerance Diabetic Retinopathy - drug therapy Diabetic Retinopathy - physiopathology Diabetic Retinopathy - surgery Diabetic Retinopathy - therapy Endocrine pancreas. Apud cells (diseases) Endocrinopathies Endpoint Determination Etiopathogenesis. Screening. Investigations. Target tissue resistance Female Humans Injections Laser Coagulation Macular Edema - drug therapy Macular Edema - physiopathology Macular Edema - surgery Macular Edema - therapy Male Medical sciences Middle Aged Miscellaneous Ophthalmology Prospective Studies Ranibizumab Tomography, Optical Coherence Treatment Outcome Visual Acuity - physiology Vitreous Body |
| title | Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-07T12%3A29%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Primary%20End%20Point%20(Six%20Months)%20Results%20of%20the%20Ranibizumab%20for%20Edema%20of%20the%20mAcula%20in%20Diabetes%20(READ-2)%20Study&rft.jtitle=Ophthalmology%20(Rochester,%20Minn.)&rft.au=QUAN%20DONG%20NGUYEN&rft.aucorp=READ-2%20Study%20Group&rft.date=2009-11-01&rft.volume=116&rft.issue=11&rft.spage=2175&rft.epage=2181&rft.pages=2175-2181&rft.issn=0161-6420&rft.eissn=1549-4713&rft.coden=OPHTDG&rft_id=info:doi/10.1016/j.ophtha.2009.04.023&rft_dat=%3Cproquest_cross%3E66634603%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=66634603&rft_id=info:pmid/19700194&rfr_iscdi=true |