Eye Surgeons@ Novena, Mount Elizabeth Novena Specialist Centre, Singapore, Singapore.
Tokyo Medical and Dental University, Bunkyo-ku, Japan.
Retina. 2018 Nov;38(11):2228-2238. doi: 10.1097/IAE.0000000000001858.
To evaluate long-term efficacy and safety of ranibizumab for treatment of myopic choroidal neovascularization (mCNV) in clinical practice.
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.
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.
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.
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。
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。
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。
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。