A prospective randomized clinical trial on intravitreous injection of Conbercept combined with laser photocoagulation for macular edema secondary to branch retinal vein occlusion_Chinese Journal of Ocular Fundus Diseases

Authors：

ZhangJing , CaiXiaojun , ChenXiaomin , 郑恬 , 郭别川 , 韩芳芳 , 王越 ,  柯敏

Department of Ophthalmology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China;

Corresponding author：

柯敏, Email: keminyk@163.com

Keywords：

Retinal vein occlusion/therapy; Angiogenesis inhibitors/therapeutic use; Antibodies; monoclonal/therapeutic use; Laser coagulation

DOI：

10.3760/cma.j.issn.1005-1015.2015.01.007

Video：

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Objective To investigate the effects and safety of intravitreous injection of Conbercept combined with laser photocoagulation for macular edema secondary to branch retinal vein occlusion. Methods All subjects were assigned randomly to 3 groups:intravitreal Conbercept combined with laser photocoagulation group (CL group), intravitreal triamcinolone combined with laser photocoagulation group (TL group), and photocoagulation group (L group). The best-corrected visual acuity (BCVA), central macular thickness (CMT), fundus oculi and fundus fluorescein angiography (FFA), intraocular pressure (IOP), slit lamp were observed before and 1 day, 1 week, 1 month, 3 months after treatment. The changes of post-treatment BCVA and CMT in pre-therapy and post-treatment were compared, and related complications were recorded. Results There were significant differences of BCVA (χ²=9.754, 12.430, 17.424, 13.189) and CMT (F=10.614, 4.099, 4.927, 8.99) between 3 groups in post-treatment 1 day, 1 week, 1 month and 3 months. The numbers of subjects of improving and stabilizing BCVA in CL group were remarkably more than that in L group in every post-treatment follow-up time (P < 0.01), whereas the CMTs in CL group were significantly less than that in L group in every post-treatment follow-up time (P < 0.05). The CMTs in post-treatment 1 day, 1 week, 1 month, 3 months were thinner than that in pretreatment in CL group and TL group (P < 0.05). Meanwhile, there was no significant difference (P > 0.05)between any two CMTs in post-treatment 1 day, 1 week, 1 month and 3 months in CL group. Yet, the CMT in post-treatment 3 months was thicker than those in post-treatment 1 day, 1 week and 1 month in TL group(P < 0.05). And there was no significant difference(P > 0.05)between any two CMTs in post-treatment 1 day, 1 week and 1 month in TL group. There was no conspicuous difference in CMTs(P > 0.05)between in CL group and in TL group in every viewing time, except for that in post-treatment 3 months(P < 0.05). There was only 1 case of intraocular hypertension in post-treatment in TL group. Conclusions Intravitreous injection of Conbercept combined with laser photocoagulation for macular edema secondary to BRVO is effective, safe, and superior to laser photocoagulation only. Also it had a longer effective duration and less complications than intravitreal triamcinolone combined with laser photocoagulation.

Citation： ZhangJing, CaiXiaojun, ChenXiaomin. A prospective randomized clinical trial on intravitreous injection of Conbercept combined with laser photocoagulation for macular edema secondary to branch retinal vein occlusion. Chinese Journal of Ocular Fundus Diseases, 2015, 31(1): 22-26. doi: 10.3760/cma.j.issn.1005-1015.2015.01.007 Copy

1.	Pitcher JD 3rd, Liu T, Prasad PS, et al. Short-duration focal pattern grid photocoagulation for macular edema secondary to branch retinal vein occlusion[J]. Semin Ophthalmol, 2012, 27(3-4):69-72.
2.	Finkelstein D. Argon laser photocoagulation for macular edema in branch vein occlusion[J]. Ophthalmology, 1986, 93(7):975-977.
3.	喻晓兵, 戴虹, 龙力.玻璃体腔曲安奈德注射联合黄斑格栅样光凝治疗糖尿病性弥漫性黄斑水肿[J].中国实用眼科杂志, 2007, 25(10):1088-1089.
4.	Noma H, Funatsu H, Yamasaki M, et al. Pathogenesis of macular edema with branch retinal vein occlusion and intraocular levels of vascular endothelial growth factor and interleukin-6[J]. Am J Ophthalmol, 2005, 140(2):256-261.
5.	Hirashima T, Chihara T, Bun T, et al. Intravitreal bevacizumab alone or combined with macular laser photcoagulation for recurrent or persistent macular edema secondary to branch retinal vein occlusion. J Ophthalmol, 2014, 2014:173084.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4119681/pdf/JOPH2014-173084.pdf.
6.	Tan MH, McAllister IL, Gillies ME, et al. Randomized controlled trial of intravitreal ranibizumab versus standard grid laser for macular edema following branch retinal vein occlusion[J]. Am J Ophthalmol, 2014, 157(1):237-247.
7.	郑红梅, 邢怡桥, 陈长征, 等.玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab联合格栅样激光光凝治疗视网膜分支静脉阻塞合并黄斑水肿疗效观察[J].中华眼底病杂志, 2012, 28(5):472-476.
8.	钱彤, 黎晓新, 尹虹, 等.玻璃体腔注射avastin治疗视网膜分支静脉阻塞继发黄斑水肿疗效观察[J].眼科研究, 2010, 28(1):79-82.
9.	Chen CH, Chen YH, Wu PC, et al. Treatment of branch retinal vein occlusion induced macular edema in treatment-naïve cases with a single intravitreal triamcinolone or bevacizumab injection[J]. Chang Gung Med J, 2010, 33(4):424-435.
10.	Feng J, Zhao T, Zhang Y, et al. Differences in aqueous concentrations of cytokines in macular edema secondary to branch and central retinal vein occlusion. PLoS One, 2013, 8(7):E68149. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3702559/pdf/pone.0068149.pdf.
11.	胡磊, 马伟键, 陈迪, 等.单独玻璃体腔曲安奈德注射与合并黄斑格栅样光凝治疗糖尿病黄斑水肿的对照研究[J].临床眼科杂志, 2009, 17(6):495-497.
12.	Yoshimura T, Sonoda KH, Sugahara M, et al. Comprehensive analysis of inflammatory immune mediators in vitreoretinal diseases. Plos One, 2009, 4(12):8158. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780733/pdf/pone.0008158.pdf.
13.	Pfister M, Rothweiler F, Michaelis M, et al. Correlation of inflammatory and proangiogenic cytokines from undiluted vitreous samples with spectral domain OCT scans, in untreated branch retinal vein occlusion[J]. Clin Ophthalmol, 2013, 7:1061-1067.
14.	Demir M, Oba E, Guven D, et al. Results of intravitreal triamcinolone acetonide in patients with macular edema secondary to branch retinal vein occlusion[J]. Int J Clin Pharm, 2014, 36(2):438-442.
15.	Rehak J, Rehak M. Branch retinal vein occlusion:pathogenesis, visual prognosis, and treatment modalities[J]. Curr Eye Res, 2008, 33(2):111-131.
16.	Pielen A, Mirshahi A, Feltgen N, et al. Ranibizumab for branch retinal vein occlusion associated macular edema study (RABAMES):six-month results of a prospective randomized clinical trial. Acta Ophthalmol, 2014, 92(4):E1-9.http://dx.doi.org/10.1111/aos.12488.
17.	Tsagkataki M, Papathomas T, Lythgoe D, et al. Twenty-four-month results of intravitreal bevacizumab in macular edema secondary to branch retinal vein occlusion.Semin Ophthalmol, 2014, 29(5):E1-8. http://informahealthcare.com/doi/abs/10.3109/08820538.2013.874488.
18.	Wang Q, Li T, Wu Z, et al. Novel VEGF decoy receptor fusion protein conbercept targeting multiple VEGF isoforms provide remarkable anti-angiogenesis effect in vivo. PLoS One, 2013, 8(8):70544. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780733/.
19.	Wu Zh, Zhou P, Li X, et al. Structural characterization of a recombinant fusion protein by instrumental analysis and molecular modeling. PLoS One, 2013. 8(3):57642. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3587646/.
20.	Li X, Xu G, Wang Y, et al. Safety and efficacy ofconbercep in neovascular age-related macular degeneration:results from a 12-month randomized phase 2 study:AURORA study[J]. Ophthalmology, 2014, 121(9):1740-1747.
21.	Shen L, You Y, Sun S, et al. Intraocular and systemic pharmacokinetics of triamcinolone acetonide after a single 40-mg posterior subtenon application[J]. Ophthalmology, 2010, 117(12):2365-2371.
22.	Xin LS, Kevin L, Jeong EK. Ocular pharmacokinetic study of a corticosteroid by 19F MR[J]. Exp Eye Res, 2010, 91(3):347-352.
23.	贡亦清, 凌芳, 吴登雷.曲安奈德兔眼玻璃体内注射的药物代谢动力学研究[J].中国实用眼科杂志, 2008, 26(4):405-406.
24.	Hong L, Ning L, Ming Z, et al. Pharmacokinetics of a long-lasting anti-VEGF fusion protein in rabbit[J]. Exp Eye Res, 2011, 97(2012):154-159.

1. Pitcher JD 3rd, Liu T, Prasad PS, et al. Short-duration focal pattern grid photocoagulation for macular edema secondary to branch retinal vein occlusion[J]. Semin Ophthalmol, 2012, 27(3-4):69-72.
2. Finkelstein D. Argon laser photocoagulation for macular edema in branch vein occlusion[J]. Ophthalmology, 1986, 93(7):975-977.
3. 喻晓兵, 戴虹, 龙力.玻璃体腔曲安奈德注射联合黄斑格栅样光凝治疗糖尿病性弥漫性黄斑水肿[J].中国实用眼科杂志, 2007, 25(10):1088-1089.
4. Noma H, Funatsu H, Yamasaki M, et al. Pathogenesis of macular edema with branch retinal vein occlusion and intraocular levels of vascular endothelial growth factor and interleukin-6[J]. Am J Ophthalmol, 2005, 140(2):256-261.
5. Hirashima T, Chihara T, Bun T, et al. Intravitreal bevacizumab alone or combined with macular laser photcoagulation for recurrent or persistent macular edema secondary to branch retinal vein occlusion. J Ophthalmol, 2014, 2014:173084.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4119681/pdf/JOPH2014-173084.pdf.
6. Tan MH, McAllister IL, Gillies ME, et al. Randomized controlled trial of intravitreal ranibizumab versus standard grid laser for macular edema following branch retinal vein occlusion[J]. Am J Ophthalmol, 2014, 157(1):237-247.
7. 郑红梅, 邢怡桥, 陈长征, 等.玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab联合格栅样激光光凝治疗视网膜分支静脉阻塞合并黄斑水肿疗效观察[J].中华眼底病杂志, 2012, 28(5):472-476.
8. 钱彤, 黎晓新, 尹虹, 等.玻璃体腔注射avastin治疗视网膜分支静脉阻塞继发黄斑水肿疗效观察[J].眼科研究, 2010, 28(1):79-82.
9. Chen CH, Chen YH, Wu PC, et al. Treatment of branch retinal vein occlusion induced macular edema in treatment-naïve cases with a single intravitreal triamcinolone or bevacizumab injection[J]. Chang Gung Med J, 2010, 33(4):424-435.
10. Feng J, Zhao T, Zhang Y, et al. Differences in aqueous concentrations of cytokines in macular edema secondary to branch and central retinal vein occlusion. PLoS One, 2013, 8(7):E68149. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3702559/pdf/pone.0068149.pdf.
11. 胡磊, 马伟键, 陈迪, 等.单独玻璃体腔曲安奈德注射与合并黄斑格栅样光凝治疗糖尿病黄斑水肿的对照研究[J].临床眼科杂志, 2009, 17(6):495-497.
12. Yoshimura T, Sonoda KH, Sugahara M, et al. Comprehensive analysis of inflammatory immune mediators in vitreoretinal diseases. Plos One, 2009, 4(12):8158. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780733/pdf/pone.0008158.pdf.
13. Pfister M, Rothweiler F, Michaelis M, et al. Correlation of inflammatory and proangiogenic cytokines from undiluted vitreous samples with spectral domain OCT scans, in untreated branch retinal vein occlusion[J]. Clin Ophthalmol, 2013, 7:1061-1067.
14. Demir M, Oba E, Guven D, et al. Results of intravitreal triamcinolone acetonide in patients with macular edema secondary to branch retinal vein occlusion[J]. Int J Clin Pharm, 2014, 36(2):438-442.
15. Rehak J, Rehak M. Branch retinal vein occlusion:pathogenesis, visual prognosis, and treatment modalities[J]. Curr Eye Res, 2008, 33(2):111-131.
16. Pielen A, Mirshahi A, Feltgen N, et al. Ranibizumab for branch retinal vein occlusion associated macular edema study (RABAMES):six-month results of a prospective randomized clinical trial. Acta Ophthalmol, 2014, 92(4):E1-9.http://dx.doi.org/10.1111/aos.12488.
17. Tsagkataki M, Papathomas T, Lythgoe D, et al. Twenty-four-month results of intravitreal bevacizumab in macular edema secondary to branch retinal vein occlusion.Semin Ophthalmol, 2014, 29(5):E1-8. http://informahealthcare.com/doi/abs/10.3109/08820538.2013.874488.
18. Wang Q, Li T, Wu Z, et al. Novel VEGF decoy receptor fusion protein conbercept targeting multiple VEGF isoforms provide remarkable anti-angiogenesis effect in vivo. PLoS One, 2013, 8(8):70544. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780733/.
19. Wu Zh, Zhou P, Li X, et al. Structural characterization of a recombinant fusion protein by instrumental analysis and molecular modeling. PLoS One, 2013. 8(3):57642. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3587646/.
20. Li X, Xu G, Wang Y, et al. Safety and efficacy ofconbercep in neovascular age-related macular degeneration:results from a 12-month randomized phase 2 study:AURORA study[J]. Ophthalmology, 2014, 121(9):1740-1747.
21. Shen L, You Y, Sun S, et al. Intraocular and systemic pharmacokinetics of triamcinolone acetonide after a single 40-mg posterior subtenon application[J]. Ophthalmology, 2010, 117(12):2365-2371.
22. Xin LS, Kevin L, Jeong EK. Ocular pharmacokinetic study of a corticosteroid by 19F MR[J]. Exp Eye Res, 2010, 91(3):347-352.
23. 贡亦清, 凌芳, 吴登雷.曲安奈德兔眼玻璃体内注射的药物代谢动力学研究[J].中国实用眼科杂志, 2008, 26(4):405-406.
24. Hong L, Ning L, Ming Z, et al. Pharmacokinetics of a long-lasting anti-VEGF fusion protein in rabbit[J]. Exp Eye Res, 2011, 97(2012):154-159.

Chinese Journal of Ocular Fundus Diseases

A prospective randomized clinical trial on intravitreous injection of Conbercept combined with laser photocoagulation for macular edema secondary to branch retinal vein occlusion

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