Transitioning from Aflibercept to Biosimilar Ranibizumab in Neovascular AMD (The TRANSFORM Trial): A Multicenter Observational Study

References

• Guymer RH, Campbell TG. Age-related macular degeneration. Lancet. 2023;401(10386):1459–1472. doi:10.1016/S0140-6736(22)02609-5
   PubMed Web of Science ®Google Scholar
• Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106–16. doi:10.1016/S2214-109X(13)70145-1
   PubMed Web of Science ®Google Scholar
• Luu KT, Seal J, Green M, Winskill C, Attar M. Effect of anti-VEGF therapy on the disease progression of neovascular age-related macular degeneration: a systematic review and model-based meta-analysis. J Clin Pharmacol. 2022;62(5):594–608. doi:10.1002/jcph.2002
   PubMed Web of Science ®Google Scholar
• Tan CS, Ngo WK, Chay IW, Ting DS, Sadda SR. Neovascular Age-Related Macular Degeneration (nAMD): a review of emerging treatment options. Clin Ophthalmol. 2022;16:917–933. doi:10.2147/OPTH.S231913
   PubMed Web of Science ®Google Scholar
• American Society of Retina Specialists. ASRS Preferences and Trends (PAT) membership survey 2018; 2023.
   Google Scholar
• Stewart MW, Narayanan R, Gupta V, Rosenfeld PJ, Martin DF, Chakravarthy U. Counterfeit avastin in India: punish the criminals not the patients. Am J Ophthalmol. 2016;170:228–231.
   PubMed Web of Science ®Google Scholar
• Sharma A, Reddy P, Kuppermann BD, Bandello F, Loewenstein A. Biosimilars in ophthalmology: “is there a big change on the horizon? Clin Ophthalmol. 2018;12:2137–2143. doi:10.2147/OPTH.S180393
   PubMed Web of Science ®Google Scholar
• Sharma A, Kumar N, Parachuri N, Bandello F, Kuppermann BD, Loewenstein A. Ranibizumab Biosimilar (Razumab) vs Innovator Ranibizumab (Lucentis) in neovascular age-related macular degeneration (n-AMD)- efficacy and safety (BIRA study). Eye. 2022;36(5):1106–1107. doi:10.1038/s41433-021-01616-9
   PubMed Web of Science ®Google Scholar
• Chakraborty D, Mondal S, Boral S, et al. Biosimilar versus innovator molecule of ranibizumab in neovascular age-related macular degeneration (The BALANCE Trial): real-world evidence. Clin Ophthalmol. 2023;17:1067–1076. doi:10.2147/OPTH.S407219
   PubMed Web of Science ®Google Scholar
• Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012;119(7):1388–1398. doi:10.1016/j.ophtha.2012.03.053
   PubMed Web of Science ®Google Scholar
• Bressler NM, Arnold J, Benchaboune M, et al.; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in patients with age-related macular degeneration: additional information regarding baseline lesion composition’s impact on vision outcomes-TAP report No. 3. Arch Ophthalmol. 2002;120(11):1443–1454.
   PubMedGoogle Scholar
• Salabati M, Obeid A, Mahmoudzadeh R, et al. Outcomes after switching eyes that were stable on aflibercept to ranibizumab versus continuing aflibercept in neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2022;260(8):2509–2516. doi:10.1007/s00417-022-05601-0
   PubMed Web of Science ®Google Scholar
• Randazzo A, Raimondi R, Fossati G, et al. Outcomes of abrupt switch to bevacizumab of patients undergoing aflibercept intravitreal injections for neovascular age-related macular degeneration in a tertiary center in Lombardy Italy: a real-life retrospective analysis. J Ophthalmol. 2021;2021:1–4. doi:10.1155/2021/7940297
   Google Scholar
• Gale RP, Pearce I, Eter N, et al. Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study. Br J Ophthalmol. 2020;104(4):493–499. doi:10.1136/bjophthalmol-2019-314251
   PubMed Web of Science ®Google Scholar
• Marquis LM, Mantel I. Beneficial switch from aflibercept to ranibizumab for the treatment of refractory neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2020;258(8):1591–1596. doi:10.1007/s00417-020-04730-8
   PubMed Web of Science ®Google Scholar
• Bro T, Hägg S. Worth changing? Clinical effects of switching treatment in neovascular age-related macular degeneration from intravitreal ranibizumab and aflibercept to bevacizumab in a region in southern Sweden. Eur J Ophthalmol. 2021;31(1):144–148. doi:10.1177/1120672119883602
   PubMed Web of Science ®Google Scholar
• Sumarová P, Ovesná P, Matušková V, et al. Effect of ranibizumab and aflibercept on retinal pigment epithelial detachement subretinal and intraretinal fluid in age-related macular degeneration. Cesk Slov Oftalmol. 2022;78(4):176–185. doi:10.31348/2022/20
   PubMedGoogle Scholar
• Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y; ALTAIR Investigators. Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR: a randomized controlled trial. Adv Ther. 2020;37(3):1173–1187. doi:10.1007/s12325-020-01236-x
   PubMed Web of Science ®Google Scholar
• Kodjikian L, Parravano M, Clemens A, et al. Fluid as a critical biomarker in neovascular age-related macular degeneration management: literature review and consensus recommendations. Eye. 2021;35:2119–2135. doi:10.1038/s41433-021-01487-0
   PubMed Web of Science ®Google Scholar
• Darrad KM, Narendran N, Yang CY. Correlation between age of onset and number of ranibizumab injections required in patients with wet age related macular degeneration. Invest Ophthalmol Vis Sci. 2014;55(13):3874.
   Web of Science ®Google Scholar
• Shor R, Barak A, Loewenstein A, et al. Is there a dose-response relationship? Real-world outcomes of anti-vascular endothelial growth factor treatment in neovascular age-related macular degeneration. Ophthalmologica. 2022;245(5):395–402. PMID: 35732142. doi:10.1159/000525653
   PubMed Web of Science ®Google Scholar
• Flores R, Carneiro Â, Vieira M, Tenreiro S, Seabra MC. Age-related macular degeneration: pathophysiology, management, and future perspectives. Ophthalmologica. 2021;244(6):495–511. PMID: 34130290. doi:10.1159/000517520
   PubMed Web of Science ®Google Scholar
• Ashraf M, Souka AAR. Aflibercept in age-related macular degeneration: evaluating its role as a primary therapeutic option. Eye. 2017;31(11):1523–1536. PMID: 28548650; PMCID: PMC5684459. doi:10.1038/eye.2017.81
   PubMed Web of Science ®Google Scholar
• Sengupta S. Current perspectives on use of anti-vascular endothelial growth factor agents for retinal disorders. Indian J Ophthalmol. 2021;69(2):209–210. doi:10.4103/ijo.IJO_72_21
   PubMed Web of Science ®Google Scholar
• Maguire MG, Martin DF, Ying GS, et al; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Five-year outcomes with anti-vascular endothelial growth factor treatment of neovascular age-related macular degeneration: the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2016;123(8):1751–1761. PMID: 27156698; PMCID: PMC4958614. doi:10.1016/j.ophtha.2016.03.045
   PubMed Web of Science ®Google Scholar
• Chakraborty D, Stewart MW, Sheth JU, et al. Real-world safety outcomes of intravitreal ranibizumab biosimilar (Razumab) therapy for chorioretinal diseases. Ophthalmol Ther. 2021;10(2):337–348. PMID: 33864599; PMCID: PMC8079600. doi:10.1007/s40123-021-00345-2
   PubMed Web of Science ®Google Scholar
• Sharma A, Kumar N, Kuppermann BD, Francesco B, Lowenstein A. Ophthalmic biosimilars: lessons from India. Indian J Ophthalmol. 2019. 67(8):1384–1385. Erratum in: Indian J Ophthalmol. 2020 Oct;68(10):2331. PMID: 31332154; PMCID: PMC6677055. doi:10.4103/ijo.IJO_430_19.
   PubMed Web of Science ®Google Scholar