Efficacy and safety of a new ranibizumab biosimilar CKD-701 using a pro re nata treatment regimen in neovascular age-related macular degeneration: A phase 3 randomized clinical trial
This study aimed to establish the efficacy, safety, and immunogenicity equivalence of the proposed biosimilar CKD-701 with the reference ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). A total of 312 participants with active subfoveal choroidal neova...
Gespeichert in:
| Veröffentlicht in: | PloS one 2022-11, Vol.17 (11), p.e0275611-e0275611 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e0275611 |
|---|---|
| container_issue | 11 |
| container_start_page | e0275611 |
| container_title | PloS one |
| container_volume | 17 |
| creator | Yoon, Chang Ki Oh, Jaeryung Bae, Kunho Park, Un Chul Yu, Kyung-Sang Yu, Hyeong Gon |
| description | This study aimed to establish the efficacy, safety, and immunogenicity equivalence of the proposed biosimilar CKD-701 with the reference ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). A total of 312 participants with active subfoveal choroidal neovascularization were randomly assigned to either the CKD-701 (n = 156) or reference ranibizumab (n = 156) arms. The initial 3-month loading intraocular injections were followed by pro re nata (PRN) dosing for 9 months. The primary outcome was the proportion of patients with less than 15-letters of corrected visual acuity (BCVA) loss at 3 months visit (one month after last loading injection) compared to the baseline time point. The presence of retinal fluid, and changes in BCVA and central retinal thickness (CRT) were assessed as secondary efficacy outcomes. Immunogenicity and safety were evaluated in both treatment arms. In the CKD-701 arm, 143 (97.95%) patients lost |
| doi_str_mv | 10.1371/journal.pone.0275611 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_plos_</sourceid><recordid>TN_cdi_plos_journals_2736275802</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A726549173</galeid><sourcerecordid>A726549173</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5546-666523ed8fafa5c41f76d9af6435b013ce26c4d655b0136b37556bded5f632493</originalsourceid><addsrcrecordid>eNqNk9-K1DAUxoso7rr6BoIBQfSiY9s06dQLYRhXXVxY8N9tOE1POlnSZEza1dkH8_lMnSo7shfSi6anv_N96decJHmcZ4ucVvnLSzd6C2axdRYXWVExnud3kuO8pkXKi4zevbE-Sh6EcJlljC45v58cUU6rss7pcfLzVCktQe4I2JYEUDjsiFMEiMXvxIPVjb4ee2hIo13QvTbgyfrDm7TKcjIGbbuIbr0jHomFAcjgEYYe7RArnY4Lom3UclcQ5Dg1Q4epRwMDtqSHfa3FDi16GLSzr8iKbDcQkNDJv3W9vo6oNNrGjZpooME8TO4pMAEfzfeT5Mvb08_r9-n5xbuz9eo8lYyVPOWcs4Jiu1SggMkyVxVva1C8pKzJciqx4LJsOfv9xBtaMcabFlumOC3Kmp4kT_a6W-OCmCMPoqgoj4kvsyISr2dibHpsZfxyD0Zsve7B74QDLQ7fWL0RnbsSNY8SxWTxfBbw7tuIYRC9DhKNgZjauPfivMrqZUSf_oPevqOZ6sCg0Fa56CsnUbGqCs7ij69opBa3UPFqsdcynimlY_2g4cVBQ2QG_DF0MIYgzj59_H_24ush--wGu0EwwyY4M05nIRyC5R6U3oXgUf0NOc_ENBJ_0hDTSIh5JOgvoff-WA</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2736275802</pqid></control><display><type>article</type><title>Efficacy and safety of a new ranibizumab biosimilar CKD-701 using a pro re nata treatment regimen in neovascular age-related macular degeneration: A phase 3 randomized clinical trial</title><source>Public Library of Science</source><source>DOAJ Directory of Open Access Journals</source><source>PubMed Central</source><source>Free Full-Text Journals in Chemistry</source><source>EZB Electronic Journals Library</source><creator>Yoon, Chang Ki ; Oh, Jaeryung ; Bae, Kunho ; Park, Un Chul ; Yu, Kyung-Sang ; Yu, Hyeong Gon</creator><creatorcontrib>Yoon, Chang Ki ; Oh, Jaeryung ; Bae, Kunho ; Park, Un Chul ; Yu, Kyung-Sang ; Yu, Hyeong Gon</creatorcontrib><description>This study aimed to establish the efficacy, safety, and immunogenicity equivalence of the proposed biosimilar CKD-701 with the reference ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). A total of 312 participants with active subfoveal choroidal neovascularization were randomly assigned to either the CKD-701 (n = 156) or reference ranibizumab (n = 156) arms. The initial 3-month loading intraocular injections were followed by pro re nata (PRN) dosing for 9 months. The primary outcome was the proportion of patients with less than 15-letters of corrected visual acuity (BCVA) loss at 3 months visit (one month after last loading injection) compared to the baseline time point. The presence of retinal fluid, and changes in BCVA and central retinal thickness (CRT) were assessed as secondary efficacy outcomes. Immunogenicity and safety were evaluated in both treatment arms. In the CKD-701 arm, 143 (97.95%) patients lost <15 letters in the BCVA at 3 months compared to 143 (98.62%) in the reference arm (P = 0.67). The BCVA improved with a mean improvement of +7.0 (CKD-701) and +6.2 (ranibizumab) letters at 3 months (P = 0.43). The least-squares mean (SE) changes in CRT at 3 months from the baseline were -119.3 (12.0) [mu]m and -124.5 (11.9) [mu]m in the CKD-701 and ranibizumab groups, respectively (P = 0.74). The proportion of participants with subretinal or intraretinal fluid at 3, 6, and 12 months was similar between the study arms. The number (SE) of injections were 8.36 (3.13) in the CKD-701 and 8.26 (2.92) in ranibizumab (P = 0.62). The occurrence of adverse events and antidrug antibody in the study arms were also not statistically different. CKD-701 is a biosimilar to the reference ranibizumab in terms of efficacy, safety, and immunogenicity for the treatment of patients with nAMD. Moreover, improvement and maintenance of visual outcome were achieved through PRN regimen.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0275611</identifier><identifier>PMID: 36374913</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Acuity ; Age ; Age related diseases ; Antibodies ; Biological products ; Biology and Life Sciences ; Biosimilar pharmaceuticals ; Clinical trials ; Confidence intervals ; Diabetes ; Diabetic retinopathy ; Drug therapy ; Effectiveness ; Eye diseases ; Immunogenicity ; Macular degeneration ; Medicine and Health Sciences ; Monoclonal antibodies ; Patient outcomes ; Patients ; Research and Analysis Methods ; Retina ; Safety ; Social Sciences ; Testing ; Vascular endothelial growth factor ; Vascularization ; Visual acuity</subject><ispartof>PloS one, 2022-11, Vol.17 (11), p.e0275611-e0275611</ispartof><rights>COPYRIGHT 2022 Public Library of Science</rights><rights>2022 Yoon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2022 Yoon et al 2022 Yoon et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5546-666523ed8fafa5c41f76d9af6435b013ce26c4d655b0136b37556bded5f632493</citedby><cites>FETCH-LOGICAL-c5546-666523ed8fafa5c41f76d9af6435b013ce26c4d655b0136b37556bded5f632493</cites><orcidid>0000-0002-1795-202X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9662729/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9662729/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids></links><search><creatorcontrib>Yoon, Chang Ki</creatorcontrib><creatorcontrib>Oh, Jaeryung</creatorcontrib><creatorcontrib>Bae, Kunho</creatorcontrib><creatorcontrib>Park, Un Chul</creatorcontrib><creatorcontrib>Yu, Kyung-Sang</creatorcontrib><creatorcontrib>Yu, Hyeong Gon</creatorcontrib><title>Efficacy and safety of a new ranibizumab biosimilar CKD-701 using a pro re nata treatment regimen in neovascular age-related macular degeneration: A phase 3 randomized clinical trial</title><title>PloS one</title><description>This study aimed to establish the efficacy, safety, and immunogenicity equivalence of the proposed biosimilar CKD-701 with the reference ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). A total of 312 participants with active subfoveal choroidal neovascularization were randomly assigned to either the CKD-701 (n = 156) or reference ranibizumab (n = 156) arms. The initial 3-month loading intraocular injections were followed by pro re nata (PRN) dosing for 9 months. The primary outcome was the proportion of patients with less than 15-letters of corrected visual acuity (BCVA) loss at 3 months visit (one month after last loading injection) compared to the baseline time point. The presence of retinal fluid, and changes in BCVA and central retinal thickness (CRT) were assessed as secondary efficacy outcomes. Immunogenicity and safety were evaluated in both treatment arms. In the CKD-701 arm, 143 (97.95%) patients lost <15 letters in the BCVA at 3 months compared to 143 (98.62%) in the reference arm (P = 0.67). The BCVA improved with a mean improvement of +7.0 (CKD-701) and +6.2 (ranibizumab) letters at 3 months (P = 0.43). The least-squares mean (SE) changes in CRT at 3 months from the baseline were -119.3 (12.0) [mu]m and -124.5 (11.9) [mu]m in the CKD-701 and ranibizumab groups, respectively (P = 0.74). The proportion of participants with subretinal or intraretinal fluid at 3, 6, and 12 months was similar between the study arms. The number (SE) of injections were 8.36 (3.13) in the CKD-701 and 8.26 (2.92) in ranibizumab (P = 0.62). The occurrence of adverse events and antidrug antibody in the study arms were also not statistically different. CKD-701 is a biosimilar to the reference ranibizumab in terms of efficacy, safety, and immunogenicity for the treatment of patients with nAMD. Moreover, improvement and maintenance of visual outcome were achieved through PRN regimen.</description><subject>Acuity</subject><subject>Age</subject><subject>Age related diseases</subject><subject>Antibodies</subject><subject>Biological products</subject><subject>Biology and Life Sciences</subject><subject>Biosimilar pharmaceuticals</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetic retinopathy</subject><subject>Drug therapy</subject><subject>Effectiveness</subject><subject>Eye diseases</subject><subject>Immunogenicity</subject><subject>Macular degeneration</subject><subject>Medicine and Health Sciences</subject><subject>Monoclonal antibodies</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Research and Analysis Methods</subject><subject>Retina</subject><subject>Safety</subject><subject>Social Sciences</subject><subject>Testing</subject><subject>Vascular endothelial growth factor</subject><subject>Vascularization</subject><subject>Visual acuity</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNqNk9-K1DAUxoso7rr6BoIBQfSiY9s06dQLYRhXXVxY8N9tOE1POlnSZEza1dkH8_lMnSo7shfSi6anv_N96decJHmcZ4ucVvnLSzd6C2axdRYXWVExnud3kuO8pkXKi4zevbE-Sh6EcJlljC45v58cUU6rss7pcfLzVCktQe4I2JYEUDjsiFMEiMXvxIPVjb4ee2hIo13QvTbgyfrDm7TKcjIGbbuIbr0jHomFAcjgEYYe7RArnY4Lom3UclcQ5Dg1Q4epRwMDtqSHfa3FDi16GLSzr8iKbDcQkNDJv3W9vo6oNNrGjZpooME8TO4pMAEfzfeT5Mvb08_r9-n5xbuz9eo8lYyVPOWcs4Jiu1SggMkyVxVva1C8pKzJciqx4LJsOfv9xBtaMcabFlumOC3Kmp4kT_a6W-OCmCMPoqgoj4kvsyISr2dibHpsZfxyD0Zsve7B74QDLQ7fWL0RnbsSNY8SxWTxfBbw7tuIYRC9DhKNgZjauPfivMrqZUSf_oPevqOZ6sCg0Fa56CsnUbGqCs7ij69opBa3UPFqsdcynimlY_2g4cVBQ2QG_DF0MIYgzj59_H_24ush--wGu0EwwyY4M05nIRyC5R6U3oXgUf0NOc_ENBJ_0hDTSIh5JOgvoff-WA</recordid><startdate>20221114</startdate><enddate>20221114</enddate><creator>Yoon, Chang Ki</creator><creator>Oh, Jaeryung</creator><creator>Bae, Kunho</creator><creator>Park, Un Chul</creator><creator>Yu, Kyung-Sang</creator><creator>Yu, Hyeong Gon</creator><general>Public Library of Science</general><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>COVID</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1795-202X</orcidid></search><sort><creationdate>20221114</creationdate><title>Efficacy and safety of a new ranibizumab biosimilar CKD-701 using a pro re nata treatment regimen in neovascular age-related macular degeneration: A phase 3 randomized clinical trial</title><author>Yoon, Chang Ki ; Oh, Jaeryung ; Bae, Kunho ; Park, Un Chul ; Yu, Kyung-Sang ; Yu, Hyeong Gon</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5546-666523ed8fafa5c41f76d9af6435b013ce26c4d655b0136b37556bded5f632493</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Acuity</topic><topic>Age</topic><topic>Age related diseases</topic><topic>Antibodies</topic><topic>Biological products</topic><topic>Biology and Life Sciences</topic><topic>Biosimilar pharmaceuticals</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Diabetes</topic><topic>Diabetic retinopathy</topic><topic>Drug therapy</topic><topic>Effectiveness</topic><topic>Eye diseases</topic><topic>Immunogenicity</topic><topic>Macular degeneration</topic><topic>Medicine and Health Sciences</topic><topic>Monoclonal antibodies</topic><topic>Patient outcomes</topic><topic>Patients</topic><topic>Research and Analysis Methods</topic><topic>Retina</topic><topic>Safety</topic><topic>Social Sciences</topic><topic>Testing</topic><topic>Vascular endothelial growth factor</topic><topic>Vascularization</topic><topic>Visual acuity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yoon, Chang Ki</creatorcontrib><creatorcontrib>Oh, Jaeryung</creatorcontrib><creatorcontrib>Bae, Kunho</creatorcontrib><creatorcontrib>Park, Un Chul</creatorcontrib><creatorcontrib>Yu, Kyung-Sang</creatorcontrib><creatorcontrib>Yu, Hyeong Gon</creatorcontrib><collection>CrossRef</collection><collection>Opposing Viewpoints Resource Center</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>ProQuest - Health & Medical Complete保健、医学与药学数据库</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - Academic</collection><collection>ProQuest Engineering Collection</collection><collection>Biological Sciences</collection><collection>Agriculture Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest advanced technologies & aerospace journals</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yoon, Chang Ki</au><au>Oh, Jaeryung</au><au>Bae, Kunho</au><au>Park, Un Chul</au><au>Yu, Kyung-Sang</au><au>Yu, Hyeong Gon</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of a new ranibizumab biosimilar CKD-701 using a pro re nata treatment regimen in neovascular age-related macular degeneration: A phase 3 randomized clinical trial</atitle><jtitle>PloS one</jtitle><date>2022-11-14</date><risdate>2022</risdate><volume>17</volume><issue>11</issue><spage>e0275611</spage><epage>e0275611</epage><pages>e0275611-e0275611</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>This study aimed to establish the efficacy, safety, and immunogenicity equivalence of the proposed biosimilar CKD-701 with the reference ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). A total of 312 participants with active subfoveal choroidal neovascularization were randomly assigned to either the CKD-701 (n = 156) or reference ranibizumab (n = 156) arms. The initial 3-month loading intraocular injections were followed by pro re nata (PRN) dosing for 9 months. The primary outcome was the proportion of patients with less than 15-letters of corrected visual acuity (BCVA) loss at 3 months visit (one month after last loading injection) compared to the baseline time point. The presence of retinal fluid, and changes in BCVA and central retinal thickness (CRT) were assessed as secondary efficacy outcomes. Immunogenicity and safety were evaluated in both treatment arms. In the CKD-701 arm, 143 (97.95%) patients lost <15 letters in the BCVA at 3 months compared to 143 (98.62%) in the reference arm (P = 0.67). The BCVA improved with a mean improvement of +7.0 (CKD-701) and +6.2 (ranibizumab) letters at 3 months (P = 0.43). The least-squares mean (SE) changes in CRT at 3 months from the baseline were -119.3 (12.0) [mu]m and -124.5 (11.9) [mu]m in the CKD-701 and ranibizumab groups, respectively (P = 0.74). The proportion of participants with subretinal or intraretinal fluid at 3, 6, and 12 months was similar between the study arms. The number (SE) of injections were 8.36 (3.13) in the CKD-701 and 8.26 (2.92) in ranibizumab (P = 0.62). The occurrence of adverse events and antidrug antibody in the study arms were also not statistically different. CKD-701 is a biosimilar to the reference ranibizumab in terms of efficacy, safety, and immunogenicity for the treatment of patients with nAMD. Moreover, improvement and maintenance of visual outcome were achieved through PRN regimen.</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>36374913</pmid><doi>10.1371/journal.pone.0275611</doi><tpages>e0275611</tpages><orcidid>https://orcid.org/0000-0002-1795-202X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2022-11, Vol.17 (11), p.e0275611-e0275611 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2736275802 |
| source | Public Library of Science; DOAJ Directory of Open Access Journals; PubMed Central; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Acuity Age Age related diseases Antibodies Biological products Biology and Life Sciences Biosimilar pharmaceuticals Clinical trials Confidence intervals Diabetes Diabetic retinopathy Drug therapy Effectiveness Eye diseases Immunogenicity Macular degeneration Medicine and Health Sciences Monoclonal antibodies Patient outcomes Patients Research and Analysis Methods Retina Safety Social Sciences Testing Vascular endothelial growth factor Vascularization Visual acuity |
| title | Efficacy and safety of a new ranibizumab biosimilar CKD-701 using a pro re nata treatment regimen in neovascular age-related macular degeneration: A phase 3 randomized clinical trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-07T17%3A21%3A13IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20safety%20of%20a%20new%20ranibizumab%20biosimilar%20CKD-701%20using%20a%20pro%20re%20nata%20treatment%20regimen%20in%20neovascular%20age-related%20macular%20degeneration:%20A%20phase%203%20randomized%20clinical%20trial&rft.jtitle=PloS%20one&rft.au=Yoon,%20Chang%20Ki&rft.date=2022-11-14&rft.volume=17&rft.issue=11&rft.spage=e0275611&rft.epage=e0275611&rft.pages=e0275611-e0275611&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0275611&rft_dat=%3Cgale_plos_%3EA726549173%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2736275802&rft_id=info:pmid/36374913&rft_galeid=A726549173&rfr_iscdi=true |