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东亚患者 RADIANCE 研究中雷珠单抗治疗近视性脉络膜新生血管的长期结果。

LONG-TERM OUTCOMES OF RANIBIZUMAB TREATMENT OF MYOPIC CHOROIDAL NEOVASCULARIZATION IN EAST-ASIAN PATIENTS FROM THE RADIANCE STUDY.

机构信息

Eye Surgeons@ Novena, Mount Elizabeth Novena Specialist Centre, Singapore, Singapore.

Tokyo Medical and Dental University, Bunkyo-ku, Japan.

出版信息

Retina. 2018 Nov;38(11):2228-2238. doi: 10.1097/IAE.0000000000001858.

Abstract

PURPOSE

To evaluate long-term efficacy and safety of ranibizumab for treatment of myopic choroidal neovascularization (mCNV) in clinical practice.

METHODS

Noninterventional, retrospective cohort study of East-Asian patients previously treated with ranibizumab during the RADIANCE trial. Forty-one patients who completed the RADIANCE trial were followed-up for up to 48 months (post-RADIANCE observation period). Outcome measures were best-corrected visual acuity changes from baseline (assessed at RADIANCE trial initiation), mCNV recurrences, and ocular adverse events.

RESULTS

Mean visual gain from baseline best-corrected visual acuity (56.5 ± 12.1 letters) (20/80) was significant at 12 months (+14.3 ± 11.4 letters, n = 40, P < 0.0001), 24 months (+10.4 ± 22.3 letters, n = 31, P = 0.0143), 30 months (+11.0 ± 22.4 letters, n = 29, P = 0.0134), 42 months (+12.9 ± 20.9 letters, n = 25, P = 0.0051), and 48 months (+16.3 ± 18.7, n = 16, P = 0.0034). Of the 16 patients who completed 48 months of follow-up, 63% gained ≥10 letters and 13% lost ≥10 letters. Over the post-RADIANCE observation period, 83% of patients required no further treatment for mCNV, 10% experienced mCNV recurrences, and 12% experienced a nonserious ocular adverse event. Patients who required additional treatment for mCNV received a mean of 5.0 (SD 5.9, range 1.0-18.0) ranibizumab injections.

CONCLUSION

Best-corrected visual acuity gained at the end of the RADIANCE trial was sustained over additional 36 months of follow-up. Few patients required further treatment and no new safety concerns were observed.

摘要

目的

评估雷珠单抗治疗近视性脉络膜新生血管(mCNV)的长期疗效和安全性。

方法

对参加 RADIANCE 试验的东亚患者进行回顾性、非干预性队列研究。41 例完成 RADIANCE 试验的患者接受了长达 48 个月的随访(RADIANCE 后观察期)。主要观察指标为从基线开始的最佳矫正视力变化(在 RADIANCE 试验开始时评估)、mCNV 复发和眼部不良事件。

结果

12 个月时(n=40),平均最佳矫正视力(56.5±12.1 个字母)(20/80)较基线显著提高(+14.3±11.4 个字母,P<0.0001),24 个月(n=31)、30 个月(n=29)、42 个月(n=25)和 48 个月(n=16)分别提高(+10.4±22.3 个字母,P=0.0143)、(+11.0±22.4 个字母,P=0.0134)、(+12.9±20.9 个字母,P=0.0051)和(+16.3±18.7 个字母,P=0.0034)。16 例完成 48 个月随访的患者中,63%的患者视力提高≥10 个字母,13%的患者视力下降≥10 个字母。在 RADIANCE 后观察期内,83%的患者无需进一步治疗 mCNV,10%的患者 mCNV 复发,12%的患者出现非严重眼部不良事件。需要进一步治疗 mCNV 的患者平均接受了 5.0(SD 5.9,范围 1.0-18.0)次雷珠单抗注射。

结论

RADIANCE 试验结束时的最佳矫正视力提高在后续 36 个月的随访中得以维持。很少有患者需要进一步治疗,也没有观察到新的安全问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe38/6221407/8425cc3c196e/retina-38-2228-g001.jpg

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