Real-world effectiveness and safety of ranibizumab for the treatment of myopic choroidal neovascularization: Results from the LUMINOUS study


Autoři: Robin D. Hamilton aff001;  Andreas Clemens aff002;  Angelo Maria Minnella aff004;  Timothy Y. Y. Lai aff005;  Hong Dai aff006;  Taiji Sakamoto aff007;  Chui Ming Gemmy Cheung aff008;  Nor Fariza Ngah aff009;  Cornelia Dunger-Baldauf aff002;  Frank G. Holz aff010
Působiště autorů: Department of Medical Retina, Moorfields Eye Hospital NHS Foundation Trust and National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at Moorfields Eye Hospital, London, United Kingdom aff001;  Medical Affairs Region Europe, Ophthalmology, Novartis Pharma AG, Basel, Switzerland aff002;  Department of Cardiology and Angiology I, Heart Center Freiburg University, Faculty of Medicine, University of Freiburg, Freiburg, Germany aff003;  Department of Ophthalmology, Catholic University of Sacred Hearth—Foundation “Policlinico Universitario A. Gemelli"—IRCCS, Rome, Italy aff004;  Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Hong Kong SAR, China aff005;  Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Beijing, China aff006;  Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan aff007;  Singapore Eye Research Institute, Singapore National Eye Centre, Singapore aff008;  Hospital Shah Alam, Selangor, Malaysia aff009;  Department of Ophthalmology, University of Bonn, Bonn, Germany aff010
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
doi: 10.1371/journal.pone.0227557

Souhrn

Purpose

To assess the 1-year effectiveness, safety, and treatment patterns of ranibizumab in patients with myopic choroidal neovascularization (mCNV) enrolled in the LUMINOUS study.

Methods

This 5-year, prospective, multicenter, observational, study enrolled 30,138 patients across all approved ranibizumab indications from outpatient ophthalmology clinics. 297 consenting patients (≥18 years) with mCNV who were treatment-naïve or prior-treated with ranibizumab or other ocular treatments were enrolled, and treated with ranibizumab according to the local product label. The main outcomes are visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters or equivalent), adverse events during the study, and treatment exposure over 1 year. Results are presented by prior treatment status of the study eye and injection frequency.

Results

Of the 297 mCNV patients recruited in the study, 108 were treatment-naïve and 175 were prior ranibizumab-treated. At baseline, the mean age of patients was 57.6 years, and 59.0 years and 80.6% and 65.7% were female in the treatment-naïve and prior ranibizumab-treated groups, respectively. Most were Caucasian (treatment-naïve, 88.9%; prior ranibizumab-treated, 86.9%). The mean (±standard deviation [SD]) VA letter changes to 1 year were +9.7 (±17.99) from 49.5 (±20.51) and +1.5 (±13.15) from 58.5 (±19.79) and these were achieved with a mean (SD) of 3.0 (±1.58) and 2.6 (±2.33) injections in the treatment-naïve and prior ranibizumab-treated groups, respectively. Presented by injection frequencies 1–2, 3–4 and ≥5 injections in Year 1, the mean (SD) VA changes were +15.0 (±14.70), +7.7 (±19.91) and −0.7 (±16.05) in treatment-naïve patients and +1.5 (±14.57), +3.1 (±11.53) and −3.6 (±11.97) in prior ranibizumab-treated patients, respectively. The safety profile was comparable with previous ranibizumab studies.

Conclusions

Ranibizumab treatment for mCNV showed robust VA gains in treatment-naïve patients and VA maintenance in prior ranibizumab-treated patients in a clinical practice setting, consisting mainly of Caucasians. No new safety signals were observed during the study.

Klíčová slova:

Adverse events – Diabetic retinopathy – Eyes – Hemorrhage – Myopia – Retinal detachment – Vasculogenesis – Visual acuity


Zdroje

1. Oishi A, Yamashiro K, Tsujikawa A, Ooto S, Tamura H, Nakata I, et al. Long-term effect of intravitreal injection of anti-VEGF agent for visual acuity and chorioretinal atrophy progression in myopic choroidal neovascularization. Graefes Arch Clin Exp Ophthalmol. 2013;251(1):1–7. doi: 10.1007/s00417-012-2022-8 22527326

2. Flitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, et al. IMI—Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019;60(3):M20–M30. doi: 10.1167/iovs.18-25957 30817826; PubMed Central PMCID: PMC6735818.

3. Neelam K, Cheung CM, Ohno-Matsui K, Lai TY, Wong TY. Choroidal neovascularization in pathological myopia. Prog Retin Eye Res. 2012;31(5):495–525. doi: 10.1016/j.preteyeres.2012.04.001 22569156

4. Ikuno Y, Jo Y, Hamasaki T, Tano Y. Ocular risk factors for choroidal neovascularization in pathologic myopia. Invest Ophthalmol Vis Sci. 2010;51(7):3721–5. doi: 10.1167/iovs.09-3493 20207975

5. Wong TY, Ferreira A, Hughes R, Carter G, Mitchell P. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence-based systematic review. Am J Ophthalmol. 2014;157(1):9–25 e12. doi: 10.1016/j.ajo.2013.08.010 24099276

6. Kempen JH, Mitchell P, Lee KE, Tielsch JM, Broman AT, Taylor HR, et al. The prevalence of refractive errors among adults in the United States, Western Europe, and Australia. Arch Ophthalmol. 2004;122(4):495–505. doi: 10.1001/archopht.122.4.495 15078666

7. Chan NS, Teo K Fau—Cheung CMG, Cheung CM. Epidemiology and Diagnosis of Myopic Choroidal Neovascularization in Asia. (1542-233X (Electronic)).

8. Avila MP, Weiter JJ, Jalkh AE, Trempe CL, Pruett RC, Schepens CL. Natural history of choroidal neovascularization in degenerative myopia. Ophthalmology. 1984;91(12):1573–81. doi: 10.1016/s0161-6420(84)34116-1 6084222

9. Cohen SY, Laroche A, Leguen Y, Soubrane G, Coscas GJ. Etiology of choroidal neovascularization in young patients. Ophthalmology. 1996;103(8):1241–4. doi: 10.1016/s0161-6420(96)30515-0 8764794

10. Holz FG, Tufail A, Leveziel N, Lai TY, Lanzetta P, Wong TY, et al. Ranibizumab in Myopic Choroidal Neovascularization: A Subgroup Analysis by Ethnicity, Age, and Ocular Characteristics in RADIANCE. Ophthalmologica. 2016;236(1):19–28. doi: 10.1159/000446027 27270597

11. Fredrick DR. Myopia. BMJ. 2002;324(7347):1195–9. doi: 10.1136/bmj.324.7347.1195 12016188; PubMed Central PMCID: PMC1123161.

12. Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, et al. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000;41(9):2486–94. 10937558

13. Wong YL, Saw SM. Epidemiology of Pathologic Myopia in Asia and Worldwide. Asia Pac J Ophthalmol (Phila). 2016;5(6):394–402. doi: 10.1097/APO.0000000000000234 27898442

14. Munk MR, Ruckert R, Zinkernagel M, Ebneter A, Wolf S. The role of anti-VEGF agents in myopic choroidal neovascularization: Current standards and future outlook. Expert Opin Biol Ther. 2016;16(4):477–87. doi: 10.1517/14712598.2016.1132696 26666589

15. Lai TY. Anti-vascular endothelial growth factor therapy for myopic choroidal neovascularization: do we need more evidence? Retina. 2012;32(8):1443–5. doi: 10.1097/IAE.0b013e31826956e4 22922844

16. Lai TY, Cheung CM. MYOPIC CHOROIDAL NEOVASCULARIZATION: Diagnosis and Treatment. Retina. 2016;36(9):1614–21. doi: 10.1097/IAE.0000000000001227 27482641

17. Ohno-Matsui K, Ikuno Y, Lai TYY, Gemmy Cheung CM. Diagnosis and treatment guideline for myopic choroidal neovascularization due to pathologic myopia. Prog Retin Eye Res. 2018;63:92–106. doi: 10.1016/j.preteyeres.2017.10.005 29111299

18. Tufail A, Patel PJ, Sivaprasad S, Amoaku W, Browning AC, Cole M, et al. Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study. Eye (Lond). 2013;27(6):709–15. doi: 10.1038/eye.2013.8 23449508; PubMed Central PMCID: PMC3682373.

19. Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, et al. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014;121(3):682–92 e2. doi: 10.1016/j.ophtha.2013.10.023 24326106

20. FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for Myopic Choroidal Neovascularization [Press Release]. South San Francisco, 2017 [cited 2019 13 March]. Available from: https://www.gene.com/media/press-releases/14651/2017-01-05/fda-approves-genentechslucentis-ranibiz

21. Willis J, Morse L, Vitale S, Parke DW 2nd, Rich WL, Lum F, et al. Treatment Patterns for Myopic Choroidal Neovascularization in the United States: Analysis of the IRIS Registry. Ophthalmology. 2017;124(7):935–43. doi: 10.1016/j.ophtha.2017.02.018 28372860

22. Ziemssen F, Feltgen N, Holz FG, Guthoff R, Ringwald A, Bertelmann T, et al. Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials. BMC Ophthalmol. 2017;17(1):7. doi: 10.1186/s12886-017-0401-y 28103831; PubMed Central PMCID: PMC5244516.

23. European Medical Agency [cited 2019 13 March]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000715/WC500143795.pdf

24. Christos Haritoglou—Augenklinik Herzog Carl Theodor M, Katrin Lorenz—Augenklinik und Poliklinik der Universitätsmedizin Mainz M, Kristina Markova—Augenklinik Herzog Carl Theodor M, Matthias Iwersen—Alcon Pharmaceuticals–Novartis Pharma GmbH N, Ulrike Michel—Alcon Pharmaceuticals–Novartis Pharma GmbH N, Judith Becker—Augenärzte im Basteicenter U, et al. 31 Internationaler Kongress der Deutschen Ophthalmochirurgen (DOC), 1406–16062018, Nürnberg.

25. Ohno-Matsui K, Suzaki M, Teshima R, Okami N. Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan. Eye (Lond). 2018;32(12):1871–8. doi: 10.1038/s41433-018-0192-2 30158574; PubMed Central PMCID: PMC6292850.

26. Nakanishi H, Tsujikawa A, Yodoi Y, Ojima Y, Otani A, Tamura H, et al. Prognostic factors for visual outcomes 2-years after intravitreal bevacizumab for myopic choroidal neovascularization. Eye (Lond). 2011;25(3):375–81. doi: 10.1038/eye.2010.226 21252956; PubMed Central PMCID: PMC3178312.

27. Franqueira N, Cachulo ML, Pires I, Fonseca P, Marques I, Figueira J, et al. Long-term follow-up of myopic choroidal neovascularization treated with ranibizumab. Ophthalmologica. 2012;227(1):39–44. doi: 10.1159/000333213 22056757

28. Ruiz-Moreno JM, Arias L, Montero JA, Carneiro A, Silva R. Intravitreal anti-VEGF therapy for choroidal neovascularisation secondary to pathological myopia: 4-year outcome. Br J Ophthalmol. 2013;97(11):1447–50. doi: 10.1136/bjophthalmol-2012-302973 24026146

29. Gharbiya M, Cruciani F, Parisi F, Cuozzo G, Altimari S, Abdolrahimzadeh S. Long-term results of intravitreal bevacizumab for choroidal neovascularisation in pathological myopia. Br J Ophthalmol. 2012;96(8):1068–72. doi: 10.1136/bjophthalmol-2012-301639 22661650

30. Chen Y ST, Li X, Song Y, Chang Q, Renxin Lin, Egger A, Foo A, Gekkieva M, Lai TYY. Ranibizumab versus verteporfin photodynamic therapy in Asian patients with myopic choroidal neovascularization: BRILLIANCE, a 12-month, randomized, double-masked study. Retina. 2018: doi: 10.1097/IAE.0000000000002292 [Epub ahead of print]. Epub Sep 20. 30204730

31. Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database Syst Rev. 2017;6:CD007419. doi: 10.1002/14651858.CD007419.pub5 28639415

32. Ehlken C, Helms M, Bohringer D, Agostini HT, Stahl A. Association of treatment adherence with real-life VA outcomes in AMD, DME, and BRVO patients. Clin Ophthalmol. 2018;12:13–20. doi: 10.2147/OPTH.S151611 29339917; PubMed Central PMCID: PMC5745150.

33. Freitas-da-Costa P, Pinheiro-Costa J, Carvalho B, Falcao M, Brandao E, Falcao-Reis F, et al. Anti-VEGF therapy in myopic choroidal neovascularization: long-term results. Ophthalmologica. 2014;232(1):57–63. doi: 10.1159/000360307 24852069

34. Karagiannis D, Kontadakis GA, Kaprinis K, Giarmoukakis A, Georgalas I, Parikakis EA, et al. Treatment of myopic choroidal neovascularization with intravitreal ranibizumab injections: the role of age. Clin Ophthalmol. 2017;11:1197–201. doi: 10.2147/OPTH.S135174 28790804; PubMed Central PMCID: PMC5488753.

35. Yang HS, Kim JG, Kim JT, Joe SG. Prognostic factors of eyes with naive subfoveal myopic choroidal neovascularization after intravitreal bevacizumab. Am J Ophthalmol. 2013;156(6):1201–10 e2. doi: 10.1016/j.ajo.2013.08.002 24075429

36. Kuo JZ, Ong FS, Yeung L, Wu WC, Chen YP, Wang NK, et al. Predictive factors for visual outcome to intravitreal bevacizumab in young Chinese patients with myopic choroidal neovascularization. Retina. 2011;31(9):1835–40. doi: 10.1097/IAE.0b013e31821ba2dc 21878845; PubMed Central PMCID: PMC3203533.

37. Wang J, Kang Z. Summary of prognostic factors for choroidal neovascularization due to pathological myopia treated by intravitreal bevacizumab injection. Graefes Arch Clin Exp Ophthalmol. 2012;250(12):1717–23. doi: 10.1007/s00417-012-2159-5 23007232

38. Tan NW, Ohno-Matsui K, Koh HJ, Nagai Y, Pedros M, Freitas RL, et al. Long-Term Outcomes of Ranibizumab Treatment of Myopic Choroidal Neovascularization in East-Asian Patients from the Radiance Study. Retina. 2017. doi: 10.1097/IAE.0000000000001858 28961671

39. Ng DS, Kwok AK, Tong JM, Chan CW, Li WW. Factors Influencing Need for Retreatment and Long-Term Visual Outcome after Intravitreal Bevacizumab for Myopic Choroidal Neovascularization. Retina. 2015;35(12):2457–68. doi: 10.1097/IAE.0000000000000610 26035400

40. Talks J, Daien V, Finger RP, Eldem B, Sakamoto T, Cardillo JA, et al. Utility of real-world evidence for evaluating anti-vascular endothelial growth factor treatment of neovascular age-related macular degeneration. Surv Ophthalmol. 2019. doi: 10.1016/j.survophthal.2019.02.008

41. Celorio JM, Pruett RC. Prevalence of lattice degeneration and its relation to axial length in severe myopia. Am J Ophthalmol. 1991;111(1):20–3. doi: 10.1016/s0002-9394(14)76891-6 1985485

42. Pierro L, Camesasca FI, Mischi M, Brancato R. Peripheral retinal changes and axial myopia. Retina. 1992;12(1):12–7. doi: 10.1097/00006982-199212010-00003 1565864

43. Hyams SW, Neumann E. Peripheral retina in myopia. With particular reference to retinal breaks. Br J Ophthalmol. 1969;53(5):300–6. doi: 10.1136/bjo.53.5.300 5772616; PubMed Central PMCID: PMC1207360.


Článek vyšel v časopise

PLOS One


2020 Číslo 1