Ranibizumab: A Review in Retinopathy of Prematurity

Springer Science and Business Media LLC - Tập 23 - Trang 111-117 - 2021
Arnold Lee1, Matt Shirley1
1Springer Nature, Auckland, New Zealand

Tóm tắt

Ranibizumab (Lucentis®) is a monoclonal antibody fragment targeted against VEGF-A that is the first approved anti-VEGF agent for the treatment of retinopathy of prematurity (ROP). In the pivotal, randomized, phase III RAINBOW trial in infants with ROP, the majority of intravitreal ranibizumab recipients experienced treatment success at 24 weeks, with a numerically greater treatment success rate in the ranibizumab 0.2 mg (80% of patients) than laser therapy (66%) group without reaching statistical significance for superiority. Long-term effects on vision following ranibizumab treatment are not yet known, but interim analyses from the RAINBOW extension study do not show evidence of degraded vision. Adverse reactions to ranibizumab in pediatric patients were consistent with the known safety profile in adults, with most adverse reactions attributed to the intravitreal injection procedure. Furthermore, systemic VEGF suppression was not observed in clinical trials, which is congruent with the rapid systemic clearance of ranibizumab. Overall, ranibizumab is an effective and generally well tolerated treatment for ROP and is not associated with systemic VEGF suppression. Although results for its long-term effects on vision are not yet available, ranibizumab is a promising alternative option to laser therapy for treating ROP.

Tài liệu tham khảo

American Academy of Ophthalmology. Retinopathy of prematurity-Europe. 2013. https://www.aao.org/. Accessed 23 Nov 2020. Gilbert C. Characteristics of infants with severe retinopathy of prematurity in countries with low, moderate, and high levels of development: implications for screening programs. Pediatrics. 2005;115(5):e518–25. Hartnett ME. Pathophysiology and mechanisms of severe retinopathy of prematurity. Ophthalmology. 2015;122(1):200–10. Mintz-Hittner HA, Kennedy KA, Chuang AZ. Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity. N Engl J Med. 2011;364(7):603–15. European Medicines Agency. Lucentis (ranibizumab) EPAR assessment report variation [procedure no. EMEA/H/C/000715/II/0074/G]. 2020. https://www.ema.europa.eu/. Accessed 23 Nov 2020. Houston SK, Wykoff CC, Berrocal AM, et al. Laser treatment for retinopathy of prematurity. Laser Med Sci. 2011;28(2):683–92. Li Z, Zhang Y, Liao Y, et al. Comparison of efficacy between anti-vascular endothelial growth factor (VEGF) and laser treatment in type-1 and threshold retinopathy of prematurity (ROP). BMC Ophthalmol. 2018;18:1. Blick SKA, Keating GM, Wagstaff AJ. Ranibizumab. Drugs. 2007;67(8):1199–206. Garnock-Jones KP. Ranibizumab in macular oedema following retinal vein occlusion. Drugs. 2011;71(4):455–63. Frampton JE. Ranibizumab in diabetic macular oedema. Drugs. 2012;72(4):509–23. Frampton JE. Ranibizumab: a review of its use in the treatment of neovascular age-related macular degeneration. Drugs Aging. 2013;30(5):331–58. European Medicines Agency. Lucentis (ranibizumab): summary of product characteristics. 2020. https://www.ema.europa.eu/. Accessed 23 Nov 2020. Stahl A, Lepore D, Fielder A, et al. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019;394(10208):1551–9. Stahl A, Krohne TU, Eter N, et al. Comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity: a randomized clinical trial. JAMA Pediatrics. 2018;172(3):278–86. Wu WC, Shih CP, Lien R, et al. Serum vascular endothelial growth factor after bevacizumab or ranibizumab treatment for retinopathy of prematurity. Retina. 2017;37(4):694–701. Fogli S, Del Re M, Rofi E, et al. Clinical pharmacology of intravitreal anti-VEGF drugs. Eye. 2018;32(6):1010–20. Novartis. Lucentis (ranibizumab) intravitreal injection 10 mg/mL; Japanese prescribing information [Japanese]. 2020. https://www.pmda.go.jp. Accessed 29 Oct 2020. Deutsche Ophthalmologische Gesellschaft e.V. (DOG), Gesellschaft e.V. (RG), Berufsverband der Augenärzte Deutschlands e.V. (BVA). Stellungnahme der Deutschen Ophthalmologischen Gesellschaft, der Retinologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands zur anti-VEGF-therapie der frühgeborenenretinopathie [German]. Der Ophthalmologe. 2020;117(9):873–85. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Effect of retinal ablative therapy for threshold retinopathy of prematurity. Arch Ophthalmol. 2001;119(8):1120–5. Beck K, Young R, Read S, et al. The severity and associated comorbidities of retinopathy of prematurity among micro-premature infants with birth weights less than 750 grams. J Neonatal Perinatal Med. 2019;12(1):41–5. Huang Q, Zhang Q, Fei P, et al. Ranibizumab injection as primary treatment in patients with retinopathy of prematurity: anatomic outcomes and influencing factors. Ophthalmology. 2017;124(8):1156–64. Tong Q, Yin H, Zhao M, et al. Outcomes and prognostic factors for aggressive posterior retinopathy of prematurity following initial treatment with intravitreal ranibizumab. BMC Ophthalmol. 2018;18:150. Chiang MF. How does the standard of care evolve? Anti–vascular endothelial growth factor agents in retinopathy of prematurity treatment as an example. Ophthalmology. 2018;125(10):1485–7. Haigh JJ. Role of VEGF in organogenesis. Organogenesis. 2014;4(4):247–56. Fidler M, Fleck BW, Stahl A, et al. Ranibizumab population pharmacokinetics and free VEGF pharmacodynamics in preterm infants with retinopathy of prematurity in the RAINBOW trial. Transl Vis Sci Technol. 2020;9:8.