Comparison of the effectiveness of ranibizumab and pegaptanib sodium in the treatment of diabetic macular edema
Authors:
Jana Štefaničková; Jaroslav Hasa
Authors place of work:
Klinika oftalmológie LF UK a UNB, Nemocnica Ružinov, Bratislava
Published in the journal:
Forum Diab 2017; 6(1): 20-26
Category:
Topic
Summary
Objective:
To review the effectiveness of ranibizumab and pegaptanib sodium in the treatment of diffuse diabetic macular edema in a loading dose (3 injections).
Materials and Methods:
Patients with diffuse diabetic macular edema, central macular thickness (CMT) ≥ 250 μm and best-corrected visual acuity (BCVA) between 39 and 73 letters were prospectively divided into 2 groups according to the applied drug – ranibizumab (ranibizumab 0.5 mg) and pegaptanib (pegaptanib sodium 0.3 mg). According on the application schema for monitored drugs eyes treated with ranibizumab were evaluated at 4, 8 and 12 weeks and eyes treated with pegaptanib sodium after 6, 12 and 18 weeks. Best-corrected visual acuity, CMT and macular volume werere followed – up.
Results:
Prospective study enrolled 20 patients/21 eyes with diffuse DEM group ranibizumab 11 eyes and group pegaptanib 10 eyes. The value of HbA1c were 7.55, 7.95 respectively. The ranibizumab group, the baseline BCVA was 51.9 letters CMT 553.45 μm and macular volume 10.68 mm3. After 12 weeks BCVA increased +11.2 letters, mean change CMT -135.9 μm and macular volume -1.62 mm3. In the group pegaptanib baseline BCVA was 54.1 letters CMT 499,6μm and macular volume 10.4 mm3. After 18 weeks BCVA increased +3.25 letteres, mean change CMT +4.38 μm, and macular volume -0.56 mm3. In ranibizumab group, 29 injections were administered. In 4 eyes after the initial two applications treatment was discontinued in accordance with criteria to discontinue treatment (CMT ≤ 250 μm or BCVA ≥ 84 letters). In pegaptanib group 28 injections were administered, 1 patient died of cardiac failure after 10 weeks of treatment initiation.
Conclusion:
Intravitreal antivascular endothelial growth factors in the treatment of diabetic macular edema improves visual acuity and reduces central thickness and macular volume on OCT. In this study ranibizumab 0.5 mg demonstrated superior efficacy to pegaptanib sodium 0.3 mg after the initial three doses.
Key words:
diabetic macular edema, ranibizumab, pegaptanib
Received:
30. 12. 2016
Accepted:
17. 2. 2017
Zdroje
1. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol 1985; 103(12): 1796–1806.
2. Lang GE. Diabetic macular edema. Ophthalmologica 2012; 227(Suppl 1): 21–29. Dostupné z DOI: <http://dx.doi.org/10.1159/000337156>.
3. Joussen AM, Smyth N, Niessen C. Pathophysiology of diabetic macular edema. Dev Ophthalmol 2007; 39: 1–12.
4. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology 1987; 94(7): 761–774.
5. Sosna T, Bouček P, Fišer I. Diabetická retinopatie, diagnostika, prevence a léčba. Cendelín: Praha 2001.
6. Elman MJ, Aiello LP, Beck RW et al. [Diabetic Retinopathy Clinical Research Network]. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolon plus prompt laser for diabetic macular edema. Ophthalmology 2010; 117(6): 1064–1077. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2010.02.031>.
7. Sultan MB, Zhou D, Loftus J et al. A phase 2/3 multicenter randomized double masked 2 – year trial of pegaptanib sodium for the treatment of diabetic macular edema. Ophthalmology 2011;118(6): 1107–1118. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2011.02.045>.
8. Massin P, Bandello F, Garweg JG et al. Safety and efflicacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 2010; 33(11): 2399–2405. Dostupné z DOI: <http://dx.doi.org/10.2337/dc10–0493>.
9. Nguyen QD, Shah SM, Heier JS et al. Primary end point (six months) results of the ranibizumab for edema of the macula in diabetes (READ-2) Study. Ophthalmology 2009; 116(11): 2175–2181.e1.Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2009.04.023>.
10. Nguyen QD1, Tatlipinar S, Shah SM et al. Vascular endothelial growth factor is a critical stimulus for diabetic macular edema. Am J Ophthalmol 2006;142(6): 961–969.
11. Mitchell P, Bandello F, Schmidt-Erfurth U et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 2011; 118(4): 615–625. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2011.01.031>.
12. Deissler HL, Lang GE. In vitro studies on the mechanism of action of VEGF and its inhibitors. Klin Monatsbl Augenheilkd 2008; 225(7): 623–628. Dostupné z DOI: <http://dx.doi.org/10.1055/s-2008–1027513>.
13. Deissler H, Deissler H, Lang S et al. VEGF – induced effects on proliferation, migration and tight junctions are restored by ranibizumab (Lucentis) in microvascular retinal endothelial cells. Br J Ophthalmol 2008; 92(6): 839–843. Dostupné z DOI: <http://dx.doi.org/10.1136/bjo.2007.135640>.
14. Gragoudas ES, Adamis AP, Cunningham ET Jr et al. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med 2004; 351(27): 2805–2816.
15. Schmidt-Erfurth U, Lang GE, Holz FG et al. Three – year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study. Ophthalmology 2014; 121(5): 1045–1053. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2013.11.041>.
16. Elman MJ, Qin H, Aiello LP et al. [Diabetic Retinopathy Clinical Research Network]. Intravitreal Ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 3 – year randomized trial results. Ophthalmology 2012; 119(11): 2312–2318. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2012.08.022>.
17. Heier JS, Brown DM, Chong V et al. Intravitreal Aflibercept (Trap –Eye) inwet age – related macular degeneration. Ophthalmology 2012; 119(12): 2537–2548. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2012.09.006>. Erratum in Ophthalmology 2013;120(1): 209–2010.
18. Korobelnik JF, Do DV, Schmidt-Erfurth U et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology 2014;121(11): 2247–2254. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ophtha.2014.05.006>.
Štítky
Diabetology Endocrinology Internal medicineČlánok vyšiel v časopise
Forum Diabetologicum
2017 Číslo 1
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