{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T02:20:16Z","timestamp":1773282016607,"version":"3.50.1"},"reference-count":13,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2011,1,14]],"date-time":"2011-01-14T00:00:00Z","timestamp":1294963200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Ophthalmologica"],"published-print":{"date-parts":[[2011,5]]},"abstract":"<jats:title>Abstract.<\/jats:title><jats:p><jats:bold>Purpose:\u2002<\/jats:bold> To evaluate the long\u2010term efficacy and safety of ranibizumab administered <jats:italic>pro re nata<\/jats:italic> (PRN) in Japanese patients with choroidal neovascularization secondary to age\u2010related macular degeneration during the extension phase of the EXTEND\u2010I study.<\/jats:p><jats:p><jats:bold>Methods:\u2002<\/jats:bold> EXTEND\u2010I, an open\u2010label, multicenter, Phase I\/II study comprised: a single\u2010injection (Group A); a multiple\u2010injection (Groups A and B; the latter consisted of patients who did not participate in the single\u2010injection phase); and an extension phase. In the extension phase, a PRN regimen of ranibizumab (0.3 or 0.5\u2003mg) guided by monthly best\u2010corrected visual acuity (BCVA) score and other ophthalmic examinations was employed. The efficacy variables included the mean BCVA change from Month 12 to the last visit in Group B. Safety was assessed in all patients.<\/jats:p><jats:p><jats:bold>Results:\u2002<\/jats:bold> In the extension phase, efficacy was assessed only in Group B patients. The number of ranibizumab injections per year in the 0.3 and 0.5\u2003mg Group B patients was 4.19 and 4.27, respectively. The mean BCVA change (SD) from Month 12 to the last visit was \u22123.6 (14.82) letters for 0.3\u2003mg (<jats:italic>n<\/jats:italic>\u2003=\u200328) and \u22122.2 (7.92) letters for 0.5\u2003mg groups (<jats:italic>n<\/jats:italic>\u2003=\u200333) in Group B. Conjunctival haemorrhage and nasopharyngitis were the most commonly reported adverse events. Of the 13 serious adverse events reported, cerebral infarction (two incidences) was suspected to be study\u2010drug related.<\/jats:p><jats:p><jats:bold>Conclusions:\u2002<\/jats:bold>  <jats:italic>Pro re nata<\/jats:italic> regimen of ranibizumab guided by monthly BCVA and other ophthalmic examinations appears effective in sustaining the BCVA gained with 12 monthly injections while reducing the number of injections during the extension phase. Ranibizumab was well tolerated during the extension phase.<\/jats:p>","DOI":"10.1111\/j.1755-3768.2010.02065.x","type":"journal-article","created":{"date-parts":[[2011,1,14]],"date-time":"2011-01-14T13:34:16Z","timestamp":1295012056000},"page":"208-217","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Long\u2010term efficacy and safety of ranibizumab administered <i>pro re nata<\/i> in Japanese patients with neovascular age\u2010related macular degeneration in the EXTEND\u2010I study"],"prefix":"10.1111","volume":"89","author":[{"given":"Yasuo","family":"Tano","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahito","family":"Ohji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the EXTEND\u2010I Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2011,1,14]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.291.15.1900"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa062655"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2008.10.018"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.iae.0000242842.14624.e7"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.med.58.061705.145635"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.09-3813"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2007.11.015"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2009.159160"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.85.10.1153"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2007.10.004"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0420.2006.00736.x"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-3768.2009.01843.x"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002512-200724080-00003"}],"container-title":["Acta Ophthalmologica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1755-3768.2010.02065.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1755-3768.2010.02065.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T12:43:01Z","timestamp":1697373781000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1755-3768.2010.02065.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,1,14]]},"references-count":13,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2011,5]]}},"alternative-id":["10.1111\/j.1755-3768.2010.02065.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1755-3768.2010.02065.x","archive":["Portico"],"relation":{},"ISSN":["1755-375X","1755-3768"],"issn-type":[{"value":"1755-375X","type":"print"},{"value":"1755-3768","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,1,14]]},"assertion":[{"value":"2011-01-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}