{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T19:38:10Z","timestamp":1786649890082,"version":"build-2736575974"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>To evaluate the efficacy of a biosimilar ranibizumab (Razumab) on outcomes of retinopathy of prematurity (ROP) for the first time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This retrospective study included infants presenting with stage 3+ ROP either in zone 1 or zone 2 posterior or aggressive posterior ROP (APROP). All eligible infants received intravitreal razumab (0.25 mg\/0.025 ml) monotherapy. Follow-up was continued monthly till complete retinal vascularization was achieved while retreatment with razumab was given when recurrent neovascularization was noted. In case of no recurrence but incomplete vascularization, laser photocoagulation was done to the residual avascular retina.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      We included 118 eyes of 59 infants with a median gestational age of 30 weeks and median birth weight of 1250 grams. At presentation, APROP was found in 28 eyes (24%) of 14 babies while stage 3 disease was seen in zone 1 in another 28 eyes (24%) and the remaining 62 eyes (52%) had stage 3 ROP in zone 2 posterior region. Complete resolution of ROP along with complete vascularization was seen in 22 eyes (19%) at a median of 55 days (IQR = 31\u201356 days) and 42 eyes (35%) showed a recurrent neovascularization at a median of 51 days post razumab (IQR = 42\u201355 days). The cumulative incidence of recurrence of neovascularization (21%, 95% CI = 14%\u201329%) peaked at seven weeks and was significantly higher in eyes with APROP (43%, 95% CI = 27%\u201363%) compared to eyes without APROP (13.4%, 95%CI, 8%-22%) (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Razumab appears to be safe and effective in treating ROP, with about a third requiring reinjection at seven weeks after the first dose.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/ijo.ijo_973_22","type":"journal-article","created":{"date-parts":[[2023,2,2]],"date-time":"2023-02-02T09:22:50Z","timestamp":1675329770000},"page":"411-415","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy of a biosimilar ranibizumab monotherapy for the treatment of retinopathy of prematurity"],"prefix":"10.4103","volume":"71","author":[{"given":"Vipul","family":"Prajapati","sequence":"first","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanvi","family":"Choudhary","sequence":"additional","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilhemina","family":"Chauhan","sequence":"additional","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonali","family":"Shah","sequence":"additional","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramya","family":"Handa","sequence":"additional","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bushra","family":"Jahan","sequence":"additional","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheetal","family":"Malviya","sequence":"additional","affiliation":[{"name":"M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabyasachi","family":"Sengupta","sequence":"additional","affiliation":[{"name":"Consultant Vitreoretinal Surgeon, Future Vision Eye Care and Research Centre, Mumbai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2023,2,2]]},"reference":[{"key":"R1-20251006","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1001\/archopht.125.9.1276","article-title":"Evaluating the Cryotherapy for Retinopathy of Prematurity Study (CRYO-ROP)","volume":"125","author":"Mills","year":"2007","journal-title":"Arch Ophthalmol"},{"key":"R2-20251006","doi-asserted-by":"crossref","first-page":"456","DOI":"10.1007\/s00347-018-0720-2","article-title":"[Review of clinical trials in retinopathy of prematurity:Current state and future perspectives","volume":"115","author":"Stahl","year":"2018","journal-title":"Ophthalmologe"},{"key":"R3-20251006","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1542\/peds.2004-1413","article-title":"The incidence and course of retinopathy of prematurity:Findings from the early treatment for retinopathy of prematurity study","volume":"116","author":"Good","year":"2005","journal-title":"Pediatrics"},{"key":"R4-20251006","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1056\/NEJMoa1007374","article-title":"Efficacy of intravitreal bevacizumab for stage 3+retinopathy of prematurity","volume":"364","author":"Mintz-Hittner","year":"2011","journal-title":"N Engl J Med"},{"key":"R5-20251006","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1001\/archopht.123.7.991","article-title":"The International classification of retinopathy of prematurity revisited","volume":"123","year":"2005","journal-title":"Arch Ophthalmol"},{"key":"R6-20251006","doi-asserted-by":"crossref","first-page":"1327","DOI":"10.1001\/jamaophthalmol.2014.2772","article-title":"Refractive outcomes following bevacizumab monotherapy compared with conventional laser treatment:A randomized clinical trial","volume":"132","author":"Geloneck","year":"2014","journal-title":"JAMA Ophthalmol"},{"key":"R7-20251006","doi-asserted-by":"crossref","first-page":"e0223972","DOI":"10.1371\/journal.pone.0223972","article-title":"Involution of retinopathy of prematurity and neurodevelopmental outcomes after intravitreal bevacizumab treatment","volume":"14","author":"Chang","year":"2019","journal-title":"PLoS One"},{"key":"R8-20251006","doi-asserted-by":"crossref","first-page":"27082","DOI":"10.1038\/srep27082","article-title":"Risk of recurrence of retinopathy of prematurity after initial intravitreal ranibizumab therapy","volume":"6","author":"Chan","year":"2016","journal-title":"Sci Rep"},{"key":"R9-20251006","doi-asserted-by":"crossref","first-page":"462","DOI":"10.1080\/02713683.2016.1196709","article-title":"Comparison of bevacizumab, ranibizumab, and laser photocoagulation in the treatment of retinopathy of prematurity in Turkey","volume":"42","author":"Gunay","year":"2017","journal-title":"Curr Eye Res"},{"key":"R10-20251006","doi-asserted-by":"crossref","first-page":"1156","DOI":"10.1016\/j.ophtha.2017.03.018","article-title":"Ranibizumab injection as primary treatment in patients with retinopathy of prematurity:Anatomic outcomes and influencing factors","volume":"124","author":"Huang","year":"2017","journal-title":"Ophthalmology"},{"key":"R11-20251006","doi-asserted-by":"crossref","first-page":"e475","DOI":"10.1111\/aos.13004","article-title":"Low dose versus conventional dose of intravitreal bevacizumab injection for retinopathy of prematurity:A case series with paired-eye comparison","volume":"96","author":"Han","year":"2018","journal-title":"Acta Ophthalmol"},{"key":"R12-20251006","first-page":"CD009734","article-title":"Anti-vascular endothelial growth factor (VEGF) drugs for treatment of retinopathy of prematurity","volume":"1","author":"Sankar","year":"2018","journal-title":"Cochrane Database Syst Rev"},{"key":"R13-20251006","doi-asserted-by":"crossref","first-page":"1551","DOI":"10.1016\/S0140-6736(19)31344-3","article-title":"Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW):An open-label randomised controlled trial","volume":"394","author":"Stahl","year":"2019","journal-title":"Lancet"},{"key":"R14-20251006","doi-asserted-by":"crossref","first-page":"25","DOI":"10.2147\/EB.S189684","article-title":"Evidence to date:Ranibizumab and its potential in the treatment of retinopathy of prematurity","volume":"11","author":"Patel","year":"2019","journal-title":"Eye Brain"},{"key":"R15-20251006","doi-asserted-by":"crossref","first-page":"1719","DOI":"10.1167\/iovs.16-20680","article-title":"Recurrence of retinopathy of prematurity after intravitreal ranibizumab monotherapy:Timing and risk factors","volume":"58","author":"Lyu","year":"2017","journal-title":"Invest Ophthalmol Vis Sci"},{"key":"R16-20251006","doi-asserted-by":"crossref","first-page":"694","DOI":"10.4103\/0301-4738.99855","article-title":"Cluster endophthalmitis following multiple intravitreal bevacizumab injections from a single use vial","volume":"64","author":"Khan","year":"2016","journal-title":"Indian J Ophthalmol"},{"key":"R17-20251006","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1016\/j.ajo.2016.05.023","article-title":"Counterfeit Avastin in India:Punish the criminals, not the patients","volume":"170","author":"Stewart","year":"2016","journal-title":"Am J Ophthalmol"},{"key":"R18-20251006","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1159\/000488602","article-title":"Real-life clinical effectiveness of Razumab\u00ae(the World's First Biosimilar of Ranibizumab) in retinal vein occlusion:A subgroup analysis of the pooled retrospective RE-ENACT study","volume":"241","author":"Sharma","year":"2019","journal-title":"Ophthalmologica"},{"key":"R19-20251006","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1007\/s40123-019-00228-7","article-title":"A multicenter, retrospective study (RE-ENACT 2) on the use of Razumab\u2122 (World's First Biosimilar Ranibizumab) in wet age-related macular degeneration","volume":"9","author":"Sharma","year":"2020","journal-title":"Ophthalmol Ther"},{"key":"R20-20251006","first-page":"6","article-title":"A multicenter, retrospective study (RE-ENACT 2) on the use of RazumabTM (World's First Biosimilar Ranibizumab) in wet AMD, DME, RVO and Myopic CNV","volume":"10","author":"Sharma","year":"2019","journal-title":"J Clin Exp Ophthalmol"},{"key":"R21-20251006","doi-asserted-by":"crossref","first-page":"1752","DOI":"10.1038\/s41433-018-0151-y","article-title":"Retinopathy of prematurity in the United Kingdom:Retreatment rates, visual and structural 1-year outcomes","volume":"32","author":"Adams","year":"2018","journal-title":"Eye (Lond)"},{"key":"R22-20251006","doi-asserted-by":"crossref","first-page":"2135","DOI":"10.1177\/1120672120945101","article-title":"Conserved regression patterns of retinopathy of prematurity after intravitreal ranibizumab:A class effect","volume":"31","author":"Ji","year":"2021","journal-title":"Eur J Ophthalmol"},{"key":"R23-20251006","doi-asserted-by":"crossref","first-page":"150","DOI":"10.1186\/s12886-018-0815-1","article-title":"Outcomes and prognostic factors for aggressive posterior retinopathy of prematurity following initial treatment with intravitreal ranibizumab","volume":"18","author":"Tong","year":"2018","journal-title":"BMC Ophthalmol"},{"key":"R24-20251006","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1016\/j.ajo.2018.09.039","article-title":"A spectrum of regression following intravitreal bevacizumab in retinopathy of prematurity","volume":"198","author":"Chen","year":"2019","journal-title":"Am J Ophthalmol"},{"key":"R25-20251006","doi-asserted-by":"crossref","first-page":"2171","DOI":"10.4103\/ijo.IJO_3016_20","article-title":"Outcomes of early versus deferred laser after intravitreal ranibizumab in aggressive posterior retinopathy of prematurity","volume":"69","author":"Gangwe","year":"2021","journal-title":"Indian J Ophthalmol"}],"container-title":["Indian Journal of Ophthalmology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.4103\/ijo.IJO_973_22","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T18:59:33Z","timestamp":1786647573000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.4103\/ijo.IJO_973_22"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2]]},"references-count":25,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023]]}},"URL":"https:\/\/doi.org\/10.4103\/ijo.ijo_973_22","relation":{},"ISSN":["0301-4738","1998-3689"],"issn-type":[{"value":"0301-4738","type":"print"},{"value":"1998-3689","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2]]},"assertion":[{"value":"2022-06-10","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-09","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}