Comparison of different loading doses followed by pro re nata regimens of intravitreal conbercept for diabetic macular edema_Chinese Journal of Ocular Fundus Diseases

Authors：

Wu Qiaowei ^1,2 , Huang Zhen ² , Yan Ming ² , Ye Ya ² ,  Song Yanping ² , Ding Qin ² , Chen Xiao ²

1. The First School of Clinical Medicine, Southern Medical University, Guangzhou 510515, China;
2. Department of Ophthalmology, General Hospital of Central Theater Command, Wuhan 430070, China;

Corresponding?author：

Song Yanping, Email: songyanping@medmail.com.cn

Keywords：

Diabetic retinopathy; Macular edema; Angiogenesis inhibitors

DOI：

10.3760/cma.j.cn511434-20211123-00653

Video：

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Objective To compare and observe the efficacy and safety of different administration methods of conbercept in the treatment of diabetic macular edema (DME). Methods A retrospective clinical study. From November 2016 to November 2020, 135 eyes of 92 patients with foveal DME who were diagnosed in the Department of Ophthalmology of General Hospital of Central Theater Command received conbercept treatment were included in the study. All patients underwent best corrected visual acuity (BCVA) and optical coherence tomography (OCT) examinations. All the affected eyes received intravitreal injection of conbercept once a month for 3 months or 5 months, and then pro re nata (PRN) treatment based on the patient’s visual acuity and OCT examination results, namely 3+PRN or 5+PRN treatment plan, and divided into 3+PRN group (84 eyes) and 5+PRN group (51 eyes), respectively. There was no statistically significant difference in baseline information between the two groups of patients (P>0.05). The changes of BCVA, centre retinal thickness (CRT), the number of intravitreal injections and the occurrence of complications in the two groups were compared and observed at the end of 12 months after treatment. The independent sample Mann-Whitney test was used to compare continuous variables between groups; the χ² test was used to compare categorical variables. Results At the end of 12 months after treatment, compared with baseline, the BCVA of 3+PRN group and 5+PRN group increased by 8.8±4.4, 9.2±6.1 letters, and CRT decreased by 145.1±50.5, 148.5±82.5 μm; there was no statistically significant difference between the two groups of eyes with BCVA increasing letter number and CRT decreasing value (P=0.295, 0.548). In the 3+PRN group and 5+PRN group, the BCVA increased by more than 10 and 15 letters were 40 (47.6%, 40/84), 21 (25.0%, 21/84) eyes and 27 (52.9%, 27/51), 16 (31.4%, 16/51) eyes; there was no statistically significant difference in the proportion of the two groups with BCVA improvement> 10, 15 letters (χ²=0.360, 0.648; P=0.549, 0.421). During PRN, in the eyes of 3+PRN group and 5+PRN group, the prognosis of eyesight was unstable in 22 (26.2%, 22/84) and 6 (11.8%, 6/51) eyes; the prognosis of eyes in the two groups was unstable. Compared with the number of eyes, the difference was statistically significant (χ²=4.017, P=0.045). The number of injections into the vitreous cavity of the two groups of eyes were 4.1±2.9 and 2.4±1.8, the difference was statistically significant (P<0.001); the times of remedial photocoagulation were 1.9±1.0, 1.5±0.8 times, the difference was statistically significant (P=0.034). During the follow-up period, the overall incidence of ocular adverse events and serious adverse events in the 3+PRN group and 5+PRN group were similar, being 22.6% (19/84), 25.5% (13/51), and 8.3% (7/84), 7.8% (4/51), respectively. Conclusion Both the 3+PRN and 5+PRN regimens of conbercept can treat DME safely and effectively; the 5+PRN regimen only requires fewer PRNs to maintain a more stable therapeutic effect.

Citation： Wu Qiaowei, Huang Zhen, Yan Ming, Ye Ya, Song Yanping, Ding Qin, Chen Xiao. Comparison of different loading doses followed by pro re nata regimens of intravitreal conbercept for diabetic macular edema. Chinese Journal of Ocular Fundus Diseases, 2022, 38(1): 40-48. doi: 10.3760/cma.j.cn511434-20211123-00653 Copy

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2.	Cheung GC, Yoon YH, Chen LJ, et al. Diabetic macular oedema: evidence-based treatment recommendations for Asian countries[J]. Clin Exp Ophthalmol, 2018, 46(1): 75-86. DOI: 10.1111/ceo.12999.
3.	Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema[J]. Ophthalmology, 2014, 121(11): 2247-2254. DOI: 10.1016/j.ophtha.2014.05.006.
4.	Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase Ⅱ study[J]. Diabetes Care, 2010, 33(11): 2399-2405. DOI: 10.2337/dc10-0493.
5.	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[J]. Ophthalmology, 2011, 118(4): 615-625. DOI: 10.1016/j.ophtha.2011.01.031.
6.	Ishibashi T, Li X, Koh A, et al. The REVEAL study: ranibizumab monotherapy or combined with laser versus laser monotherapy in Asian patients with diabetic macular edema[J]. Ophthalmology, 2015, 122(7): 1402-1415. DOI: 10.1016/j.ophtha.2015.02.006.
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19.	鄧凱予, 葉婭, 黃曉莉, 等. 阿柏西普初始治療及換藥治療對滲出型老年性黃斑變性的短期療效觀察[J]. 中華眼底病雜志, 2021, 37(9): 687-692. DOI: 10.3760/cma.j.cn511434-20200827-00412.Deng KY, Ye Y, Huang XL, et al. Short-term efficacy of primary treatment and dressing change with aflibercept for exudative age-related macular degeneration[J]. Chin J Ocul Fundus Dis, 2021, 37(9): 687-692. DOI: 10.3760/cma.j.cn511434-20200827-00412.
20.	鄧凱予, 黃珍, 黃曉莉, 等. 阿柏西普治療滲出型老年性黃斑變性合并視網膜色素上皮脫離的療效觀察[J]. 中華眼底病雜志, 2020, 36(10): 764-771. DOI: 10.3760/cma.j.cn511434-20200608-00266.Deng KY, Huang Z, Huang XL, et al. The effect of aflibercept in the treatment of exudative age-related macular degeneration combined with retinal pigment epithelial detachment[J]. Chin J Ocul Fundus Dis, 2020, 36(10): 764-771. DOI: 10.3760/cma.j.cn511434-20200608-00266.
21.	陳叢, 閆明, 宋艷萍. 康柏西普不同給藥方式治療病理性近視脈絡膜新生血管的療效觀察[J]. 中華眼底病雜志, 2020, 36(8): 611-615. DOI: 10.3760/cma.j.cn511434-20191120-00380.Chen C, Yan M, Song YP. Effect of different administration of conbercept on choroidal neovasculature in patients with pathological myopia[J]. Chin J Ocul Fundus Dis, 2020, 36(8): 611-615. DOI: 10.3760/cma.j.cn511434-20191120-00380.
22.	Hu Y, Wu Q, Liu B, et al. Comparison of clinical outcomes of different components of diabetic macular edema on optical coherence tomography[J]. Graefe's Arch Clin Exp Ophthalmol, 2019, 257(12): 2613-2621. DOI: 10.1007/s00417-019-04471-3.
23.	Hu Y, Wu Q, Liu B, et al. Restoration of foveal bulge after resolution of diabetic macular edema with coexisting serous retinal detachment[J/OL]. J Diabetes Res, 2020, 2020: 9705786[2020-06-13]. https://pubmed.ncbi.nlm.nih.gov/32626784/. DOI: 10.1155/2020/9705786.
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25.	Rodríguez-Valdés PJ, Rehak M, Zur D, et al. GRAding of functional and anatomical response to DExamethasone implant in patients with diabetic macular edema: GRADE-DME study[J/OL]. Sci Rep, 2021, 11(1): 4738[2021-02-26]. https://pubmed.ncbi.nlm.nih.gov/33637772/. DOI: 10.1038/s41598-020-79288-w.
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1. Ciulla TA, Amador AG, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies[J]. Diabetes Care, 2003, 26(9): 2653-2664. DOI: 10.2337/diacare.26.9.2653.
2. Cheung GC, Yoon YH, Chen LJ, et al. Diabetic macular oedema: evidence-based treatment recommendations for Asian countries[J]. Clin Exp Ophthalmol, 2018, 46(1): 75-86. DOI: 10.1111/ceo.12999.
3. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema[J]. Ophthalmology, 2014, 121(11): 2247-2254. DOI: 10.1016/j.ophtha.2014.05.006.
4. Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase Ⅱ study[J]. Diabetes Care, 2010, 33(11): 2399-2405. DOI: 10.2337/dc10-0493.
5. 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[J]. Ophthalmology, 2011, 118(4): 615-625. DOI: 10.1016/j.ophtha.2011.01.031.
6. Ishibashi T, Li X, Koh A, et al. The REVEAL study: ranibizumab monotherapy or combined with laser versus laser monotherapy in Asian patients with diabetic macular edema[J]. Ophthalmology, 2015, 122(7): 1402-1415. DOI: 10.1016/j.ophtha.2015.02.006.
7. 中華醫學會眼科學會眼底病學組. 我國糖尿病視網膜病變臨床診療指南(2014年)[J]. 中華眼科雜志, 2014, 50(11): 851-865. DOI: 10.3760/cma.j.issn.0412-4081.2014.11.014.Ophthalmology Society of Chinese Medical Association. Clinical guidelines for the diagnosis and treatment of diabetic retinopathy in China (2014)[J]. Chin J Ophthalmol, 2014, 50(11): 851-865. DOI: 10.3760/cma.j.issn.0412-4081.2014.11.014.
8. Elman MJ, Ayala A, Bressler NM, et al. Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results[J]. Ophthalmology, 2015, 122(2): 375-381. DOI: 10.1016/j.ophtha.2014.08.047.
9. Diabetic Retinopathy Clinical Research Network, Elman MJ, Qin H, et al. Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results[J]. Ophthalmology, 2012, 119(11): 2312-2318. DOI: 10.1016/j.ophtha.2012.08.022.
10. Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic retinopathy preferred practice pattern(R)[J]. Ophthalmology, 2020, 127(1): P66-P145. DOI: 10.1016/j.ophtha.2019.09.025.
11. Liu K, Wang H, He W, et al. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study[J/OL]. Br J Ophthalmol, 2021, bjophthalmol-2020-318690(2021-05-17)[2021-11-23]. https://bjo.bmj.com/content/early/2021/05/16/bjophthalmol-2020-318690.long. DOI: 10.1136/bjophthalmol-2020-318690. [published online ahead of print].
12. Li F, Zhang L, Wang Y, et al. One-year outcome of conbercept therapy for diabetic macular edema[J]. Curr Eye Res, 2018, 43(2): 218-223. DOI: 10.1080/02713683.2017.1379542.
13. Huang Z, Ding Q, Yan M, et al. Short-term efficacy of conbercept and banibizumab for polypoidal choroidal vasculopathy[J]. Retina, 2019, 39(5): 889-895. DOI: 10.1097/IAE.0000000000002035.
14. Liu K, Song Y, Xu G, et al. Conbercept for treatment of neovascular age-related macular degeneration: results of the randomized phase 3 PHOENIX study[J]. Am J Ophthalmol, 2019, 197: 156-167. DOI: 10.1016/j.ajo.2018.08.026.
15. Seo KH, Yu SY, Kim M, et al. Visual and morphologic outcomes of intravitreal ranibizumab for diabetic macular edema based on optical coherence tomography patterns[J]. Retina, 2016, 36(3): 588-595. DOI: 10.1097/IAE.0000000000000770.
16. Liu Q, Hu Y, Yu H, et al. Comparison of intravitreal triamcinolone acetonide versus intravitreal bevacizumab as the primary treatment of clinically significant macular edema[J]. Retina, 2015, 35(2): 272-279. DOI: 10.1097/IAE.0000000000000300.
17. Shimura M, Yasuda K, Yasuda M, et al. Visual outcome after intravitreal bevacizumab depends on the optical coherence tomographic patterns of patients with diffuse diabetic macular edema[J]. Retina, 2013, 33(4): 740-747. DOI: 10.1097/IAE.0b013e31826b6763.
18. Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies[J]. Ophthalmology, 2016, 123(11): 2376-2385. DOI: 10.1016/j.ophtha.2016.07.032.
19. 鄧凱予, 葉婭, 黃曉莉, 等. 阿柏西普初始治療及換藥治療對滲出型老年性黃斑變性的短期療效觀察[J]. 中華眼底病雜志, 2021, 37(9): 687-692. DOI: 10.3760/cma.j.cn511434-20200827-00412.Deng KY, Ye Y, Huang XL, et al. Short-term efficacy of primary treatment and dressing change with aflibercept for exudative age-related macular degeneration[J]. Chin J Ocul Fundus Dis, 2021, 37(9): 687-692. DOI: 10.3760/cma.j.cn511434-20200827-00412.
20. 鄧凱予, 黃珍, 黃曉莉, 等. 阿柏西普治療滲出型老年性黃斑變性合并視網膜色素上皮脫離的療效觀察[J]. 中華眼底病雜志, 2020, 36(10): 764-771. DOI: 10.3760/cma.j.cn511434-20200608-00266.Deng KY, Huang Z, Huang XL, et al. The effect of aflibercept in the treatment of exudative age-related macular degeneration combined with retinal pigment epithelial detachment[J]. Chin J Ocul Fundus Dis, 2020, 36(10): 764-771. DOI: 10.3760/cma.j.cn511434-20200608-00266.
21. 陳叢, 閆明, 宋艷萍. 康柏西普不同給藥方式治療病理性近視脈絡膜新生血管的療效觀察[J]. 中華眼底病雜志, 2020, 36(8): 611-615. DOI: 10.3760/cma.j.cn511434-20191120-00380.Chen C, Yan M, Song YP. Effect of different administration of conbercept on choroidal neovasculature in patients with pathological myopia[J]. Chin J Ocul Fundus Dis, 2020, 36(8): 611-615. DOI: 10.3760/cma.j.cn511434-20191120-00380.
22. Hu Y, Wu Q, Liu B, et al. Comparison of clinical outcomes of different components of diabetic macular edema on optical coherence tomography[J]. Graefe's Arch Clin Exp Ophthalmol, 2019, 257(12): 2613-2621. DOI: 10.1007/s00417-019-04471-3.
23. Hu Y, Wu Q, Liu B, et al. Restoration of foveal bulge after resolution of diabetic macular edema with coexisting serous retinal detachment[J/OL]. J Diabetes Res, 2020, 2020: 9705786[2020-06-13]. https://pubmed.ncbi.nlm.nih.gov/32626784/. DOI: 10.1155/2020/9705786.
24. Wang F, Yuan Y, Wang L, et al. One-year outcomes of 1 dose versus 3 loading doses followed by pro re nata regimen using ranibizumab for neovascular age-related macular degeneration: the ARTIS trial[J/OL]. J Ophthalmol, 2019, 2019: 7530458[2019-10-10]. https://pubmed.ncbi.nlm.nih.gov/31687203/. DOI: 10.1155/2019/7530458.
25. Rodríguez-Valdés PJ, Rehak M, Zur D, et al. GRAding of functional and anatomical response to DExamethasone implant in patients with diabetic macular edema: GRADE-DME study[J/OL]. Sci Rep, 2021, 11(1): 4738[2021-02-26]. https://pubmed.ncbi.nlm.nih.gov/33637772/. DOI: 10.1038/s41598-020-79288-w.
26. Busch C, Fraser-Bell S, Zur D, et al. Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study[J]. Acta Diabetol, 2019, 56(7): 777-784. DOI: 10.1007/s00592-019-01310-z.
27. 盧穎毅, 戴虹. 從最新的指南看糖尿病黃斑水腫的治療策略和方案[J]. 中華實驗眼科雜志, 2018, 36(6): 401-403. DOI: 10.3760/cma.j.issn.2095-0160.2018.06.001.Lu YY, Dai H. Treatment strategy and plan for diabetic macular edema based on the latest guidelines[J]. Chin J Exp Ophthalmol, 2018, 36(6): 401-403. DOI: 10.3760/cma.j.issn.2095-0160.2018.06.001.
28. Baker CW, Glassman AR, Beaulieu WT, et al. Effect of initial management with aflibercept vs laser photocoagulation vs observation on vision loss among patients with diabetic macular edema involving the center of the macula and good visual acuity: a randomized clinical trial[J]. JAMA, 2019, 321(19): 1880-1894. DOI: 10.1001/jama.2019.5790.
29. Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema[J]. N Engl J Med, 2015, 372(13): 1193-1203. DOI: 10.1056/NEJMoa1414264.
30. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the management of diabetic macular edema by the European Society of Retina Specialists (EURETINA)[J]. Ophthalmologica, 2017, 237(4): 185-222. DOI: 10.1159/000458539.
31. 黎曉新. 學習推廣中國糖尿病視網膜病變防治指南, 科學規范防治糖尿病視網膜病變[J]. 中華眼底病雜志, 2015, 31(2): 117-120. DOI: 10.3760/cma.j.issn.1005-1015.2015.02.002.Li XX. Following the Chinese guideline of diabetic retinopathy in our practice[J]. Chin J Ocul Fundus Dis, 2015, 31(2): 117-120. DOI: 10.3760/cma.j.issn.1005-1015.2015.02.002.
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Chinese Journal of Ocular Fundus Diseases

Comparison of different loading doses followed by pro re nata regimens of intravitreal conbercept for diabetic macular edema

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