Safety of intravitreal ziv-aflibercept in choroido-retinal vascular diseases: A randomised double-blind intervention study
Autoři:
Imoro Zeba Braimah aff001; Ernest Kenu aff003; Kwesi N. Amissah-Arthur aff001; Stephen Akafo aff001; Kwaku Oppong Kwarteng aff002; Winfried M. Amoaku aff004
Působiště autorů:
Department of Surgery (Eye), School of Medicine and Dentistry, College of Health Sciences, University of Ghana, Accra, Ghana
aff001; Eye Centre, Korle- Bu Teaching Hospital, Korle- Bu, Accra, Ghana
aff002; Department of Epidemiology, School of Public Health, University of Ghana, Accra, Ghana
aff003; Academic Ophthalmology, DCN, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, England, United Kingdom
aff004
Vyšlo v časopise:
PLoS ONE 14(10)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0223944
Souhrn
Aim
To evaluate the safety of 1.25mg and 2mg intravitreal ziv-aflibercept (IVZ) in Ghanaian eyes with choroido-retinal vascular diseases.
Design
Prospective, randomised, double blind, interventional study.
Methods
Twenty patients with centre involving macular oedema in diabetic retinopathy, retinal vein occlusion, and neovascular age-related macular degeneration were assigned to 2 groups receiving 3 doses of 1.25mg/0.05ml (group 1) and 2mg/0.08ml IVZ (Group 2) at 4 weekly intervals. Safety data was collected after 30 minutes, 1 and 7 days, and 4, 8 and 12 weeks after injection. Changes in continuous variables were compared using paired t-test and categorical variables were compared using chi-square test of proportions. Repeated-Measures ANOVA with nesting test was used to compare variations in continuous variables by IVZ dose over time. Primary outcome measures were ocular and systemic adverse events at 4 weeks.
Results
Eleven females and nine males, with mean age of 63.2± 7.3 years were included. Ocular adverse events included subconjunctival haemorrhage in 1 eye, intraocular pressure (IOP) >21mmHg at 30 minutes in 6 eyes and mild pain in 3 eyes at 1-day. There was no significant difference in IOP rise between the 2 groups at 30 minutes (p = 0.21). No other ocular or systemic adverse events were observed. There was significant improvement in the best corrected visual acuity (LogMAR) from 0.95±0.6 to 0.6±0.4 (p<0.01) and 0.47±0.3 (p<0.01), reduction in central subfield foveal thickness from 405.9±140 um at baseline to 255.6±75 um (p<0.01) and 238±88 um (p<0.01) at 4 and 12 weeks respectively, although no difference was observed between the 2 groups (p = 0.34).
Conclusion
IVZ at 1.25mg and 2mg had similar safety profiles, and did not have any major unexpected adverse events. Further studies with larger cohorts are required to confirm efficacy.
Klíčová slova:
Adverse events – Eye diseases – Eyes – Ghana – Intraocular pressure – Ocular anatomy – Ocular system – Visual acuity
Zdroje
1. Dalal S, Beunza JJ, Volmink J, Adebamowo C, Bajunirwe F, Njelekela M, et al. Non-communicable diseases in sub-Saharan Africa: what we know now. Int J Epidem. 2011; 40(4):885–901.
2. Nazimul H, Rohit K, Anjli H. Trend of retinal diseases in developing countries. Exp Rev Ophthalmol. 2008; 3(1):43–50.
3. Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012;96(5):614–8. doi: 10.1136/bjophthalmol-2011-300539 22133988
4. Hera R, Keramidas M, Peoc’h M, Mouillon M, Romanet JP, Feige JJ. Expression of VEGF and angiopoietins in subfoveal membranes from patients with age-related macular degeneration. Am J Ophthalmol. 2005; 139(4):589–96. doi: 10.1016/j.ajo.2004.11.064 15808152
5. Ho AC, Scott IU, Kim SJ, Brown GC, Brown MM, Ip MS, et al. Anti-vascular endothelial growth factor pharmacotherapy for diabetic macular edema: a report by the American Academy of Ophthalmology. Ophthalmology. 2012; 119(10):2179–88. doi: 10.1016/j.ophtha.2012.07.058 22917890
6. Wang S, Park JK, Duh EJ. Novel targets against retinal angiogenesis in diabetic retinopathy. Curr diab rep. 2012; 12(4):355–63. doi: 10.1007/s11892-012-0289-0 22638940
7. Chung C, Pherwani N. Ziv-aflibercept: a novel angiogenesis inhibitor for the treatment of metastatic colorectal cancer. Am J Health Syst Pharm. 2013; 70(21):1887–96 doi: 10.2146/ajhp130143 24128964
8. Shah GK ST. 2017 Global Trends in Retina Survey. Chicago, IL.; 2017.
9. Amoaku WM, Chakravarthy U, Gale R, Gavin M, Ghanchi F, Gibson J, et al. Defining response to anti-VEGF therapies in neovascular AMD. Eye (Lond). 2015; 29(10):1397–8.
10. Andrade GC, Dias JR, Maia A, Farah ME, Meyer CH, Rodrigues EB. Intravitreal injections of ziv-aflibercept for diabetic macular edema: A Pilot Study. Retina (Philadelphia, Pa). 2016; 36(9):1640–5.
11. Braimah IZ, Agarwal K, Mansour A, Chhablani J. One-year outcome of intravitreal ziv-aflibercept therapy for non-responsive neovascular age-related macular degeneration. Br J Ophthalmol. 2018; 102(1):91–96. doi: 10.1136/bjophthalmol-2017-310318 28596286
12. Chhablani J, Narayanan R, Mathai A, Yogi R, Stewart M. Short-term safety profile of intravitreal ziv-aflibercept. Retina (Philadelphia, Pa). 2016; 36(6):1126–31.
13. de Andrade GC, de Oliveira Dias JR, Maia A, Farah ME, Meyer CH, Rodrigues EB. Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes. Ophthalmic surg, Lasers & Imaging Retina. 2018; 49(4):245–50.
14. de Oliveira Dias JR, Costa de Andrade G, Kniggendorf VF, Novais EA, Takahashi VKL, Maia A, et al.Intravitreal ziv-aflibercept for neovascular age-related macular degeneration: 52-Week Results. Retina (Philadelphia, Pa). 2017.
15. Mansour AM, Al-Ghadban SI, Yunis MH, El-Sabban ME. Ziv-aflibercept in macular disease. Br J Ophthalmol. 2015; 99(8):1055–9. doi: 10.1136/bjophthalmol-2014-306319 25677668
16. Mansour AM, Ashraf M, Charbaji A, Younis MH, Souka AA, Dogra A, et al. Two-year outcomes of intravitreal ziv-aflibercept. Br J Ophthalmol. 2018; 102(10):1387–1390 doi: 10.1136/bjophthalmol-2017-311591 29317400
17. Mansour AM, Chhablani J, Antonios RS, Yogi R, Younis MH, Dakroub R, et al. Three-month outcome of ziv-aflibercept for exudative age-related macular degeneration. Br J Ophthalmol. 2016; 100(12):1629–33. doi: 10.1136/bjophthalmol-2015-308319 27030277
18. Paulose R, Chhablani J, Dedhia CJ, Stewart MW, Mansour AM. Intravitreal ziv-aflibercept for macular edema following retinal vein occlusion. Clin Ophthalmol. 2016; 10:1853–8. doi: 10.2147/OPTH.S116343 27703326
19. Chhablani J, Dedhia CJ, Peguda HK, Stewart M. Short-term safety of 2mg intravitreal ziv-aflibercept. Retina (Philadelphia, Pa). 2017; 37(10):1859–65.
20. Singh SR, Stewart MW, Chattannavar G, Ashraf M, Souka A, ElDardeery M, et al. Safety of 5914 intravitreal ziv-aflibercept injections. Br J Ophthalmol. 2018:bjophthalmol-2018-312453.
21. Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005; 140(3):509–16. doi: 10.1016/j.ajo.2005.03.057 16196117
22. Caudle LE, Williams KA, Pesudovs K. The Eye Sensation Scale: an ophthalmic pain severity measure. Optom Vis Sci. 2007; 84(8):752–62. doi: 10.1097/OPX.0b013e31812f7690 17700338
23. Trichonas G, Kaiser PK. Aflibercept for the treatment of age-related macular degeneration. Ophthalmol Ther. 2013; 2(2):89–98. doi: 10.1007/s40123-013-0015-2 25135809
24. Andrade GC, Dias JR, Maia A, Farah ME, Meyer CH, Rodrigues EB. Intravitreal injections of ziv-aflibercept for diabetic macular edema: A Pilot Study. Retina. 2016;36(9):1640–5 doi: 10.1097/IAE.0000000000001000 26991646
25. Ashraf M, Souka AA, El Kayal H, El Manhaly M, Abdallah MH. Three-month outcomes of ziv-aflibercept in the treatment of diabetic macular oedema. Acta Ophthalmol. 2016; 94(7):e669. doi: 10.1111/aos.13111 27227354
26. Chhablani J. Intravitreal ziv-aflibercept for recurrent macular edema secondary to central retinal venous occlusion. Indian J Ophthalmol. 2015; 63(5):469–70. doi: 10.4103/0301-4738.159909 26139820
27. de Oliveira Dias JR, Xavier CO, Maia A, de Moraes NS, Meyer C, Farah ME, et al. Intravitreal injection of ziv-aflibercept in patient with refractory age-related macular degeneration. Ophthalmic Surg, Lasers & Imaging Retina. 2015; 46(1):91–4.
28. Mansour AM, Chhablani J, Antonios RS, Yogi R, Younis MH, Dakroub R, et al. Three-month outcome of ziv-aflibercept for exudative age-related macular degeneration. Br J Ophthalmol. 2016; 100(12):1629–1633. doi: 10.1136/bjophthalmol-2015-308319 27030277
29. Mansour AM, Dedhia C, Chhablani J. Three-month outcome of intravitreal ziv-aflibercept in eyes with diabetic macular oedema. Br J Ophthalmol.2017; 101(2):166–16. doi: 10.1136/bjophthalmol-2016-308679 27190127
30. Marashi A. Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst. 2016;4(3).
31. Malik D, Tarek M, Caceres del Carpio J, Ramirez C, Boyer D, Kenney MC, et al. Safety profiles of anti-VEGF drugs: bevacizumab, ranibizumab, aflibercept and ziv-aflibercept on human retinal pigment epithelium cells in culture. Br J Ophthalmol. 2014; 98 Suppl 1:i11–6.
32. de Oliveira Dias JR, Badaro E, Novais EA, Colicchio D, Chiarantin GM, Matioli MM, et al. Preclinical investigations of intravitreal ziv-aflibercept. Ophthalmic Surg, Lasers & Imaging Retina. 2014; 45(6):577–84.
33. Chakravarthy U, Adamis AP, Cunningham ET Jr., Goldbaum M, Guyer DR, Katz B, et al. Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration. Ophthalmology. 2006; 113(9):1508.e1–25.
34. Baghi A, Jabbarpoor Bonyadi MH, Ramezani A, Azarmina M, Moradian S, Dehghan MH, et al. Two Doses of Intravitreal Ziv-Aflibercept versus Bevacizumab in Treatment of Diabetic Macular Edema: A Three-Armed, Double-Blind Randomized Trial. Ophthalmology Retina.1 (2):103–10. doi: 10.1016/j.oret.2016.08.007 31047266
35. Jabbarpoor Bonyadi MH, Baghi A, Ramezani A, Yaseri M, Soheilian M. One-Year Results of a Trial Comparing 2 Doses of Intravitreal Ziv-aflibercept versus Bevacizumab for Treatment of Diabetic Macular Edema. Ophthalmology Retina. 2018; 2(5):428–40. doi: 10.1016/j.oret.2017.09.010 31047323
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PLOS One
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