Abstract：
OBJECTIVE: To evaluate the safety and efficacy of intravitreal injections of 0.5 mg conbercept in patients with choroidal neovascularization secondary to pathological myopia (pmCNV).
METHODS: The 177 pmCNV patients were randomly assigned in a 3:1 ratio to receive conbercept or sham injection, respectively. The conbercept group receive conbercept intravitreal injections administered on a pro re nata (PRN) basis after 3 monthly loading doses. The sham group received three consecutive monthly sham injections and then one conbercept injection followed by PRN conbercept intravitreal injections.
RESULTS: At month 3, the mean BCVA for the two groups were improved by 12.0 letters (conbercept group, from 54.05 letters to 66.05 letters) and 0.6 letters (sham group, from 49.77 letters to 50.33 letters), respectively (p < 0.001). The mean central retinal thickness (CRT) at month 3 in the two groups decreased 62.0 μm (conbercept group, from 348.90 μm to 286.18 μm) and 4.4 μm (sham group, from 347.86 μm to 343.47 μm) (p < 0.001). At month 9, the mean BCVA improved by 13.3 letters in the conbercept group and 11.3 letters in the sham group. The mean CRT decreased 73.6 μm in the conbercept group and 55.9 μm in the sham group (p < 0.001). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival haemorrhage and increased intraocular pressure.
CONCLUSIONS: Intravitreal injections of 0.5 mg conbercept provided improvement in visual and anatomical outcomes in pmCNV patients with low rates of ocular and nonocular safety events.
METHODS: The 177 pmCNV patients were randomly assigned in a 3:1 ratio to receive conbercept or sham injection, respectively. The conbercept group receive conbercept intravitreal injections administered on a pro re nata (PRN) basis after 3 monthly loading doses. The sham group received three consecutive monthly sham injections and then one conbercept injection followed by PRN conbercept intravitreal injections.
RESULTS: At month 3, the mean BCVA for the two groups were improved by 12.0 letters (conbercept group, from 54.05 letters to 66.05 letters) and 0.6 letters (sham group, from 49.77 letters to 50.33 letters), respectively (p < 0.001). The mean central retinal thickness (CRT) at month 3 in the two groups decreased 62.0 μm (conbercept group, from 348.90 μm to 286.18 μm) and 4.4 μm (sham group, from 347.86 μm to 343.47 μm) (p < 0.001). At month 9, the mean BCVA improved by 13.3 letters in the conbercept group and 11.3 letters in the sham group. The mean CRT decreased 73.6 μm in the conbercept group and 55.9 μm in the sham group (p < 0.001). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival haemorrhage and increased intraocular pressure.
CONCLUSIONS: Intravitreal injections of 0.5 mg conbercept provided improvement in visual and anatomical outcomes in pmCNV patients with low rates of ocular and nonocular safety events.
摘要：
目的：评价玻璃体内注射0.5mg康柏西普治疗病理性近视继发脉络膜新生血管（pmCNV）的安全性和有效性。
方法：177名pmCNV患者以3:1的比例随机分配接受康柏西普或假注射，分别。康柏西普组在3个月的负荷剂量后接受康柏西普玻璃体内注射，以先纳达（PRN）为基础。假手术组接受三个连续的每月假注射，然后接受一次康柏西普注射，然后接受PRN康柏西普玻璃体内注射。
结果：在第3个月，两组的平均BCVA提高了12.0个字母（conbercept组，从54.05个字母到66.05个字母）和0.6个字母（假组，从49.77个字母到50.33个字母)，分别(p<0.001)。两组在3个月时的平均中央视网膜厚度（CRT）下降了62.0μm（康柏西普组，从348.90μm到286.18μm)和4.4μm(假手术组，从347.86μm到343.47μm）（p<0.001）。在第9个月，康柏西普组的平均BCVA提高了13.3个字母，假手术组的平均BCVA提高了11.3个字母。康柏西普组平均CRT降低73.6μm,假手术组降低55.9μm(p<0.001)。最常见的眼部不良事件与玻璃体内注射有关，如结膜出血和眼压升高。
结论：玻璃体内注射0.5mg康柏西普改善了pmCNV患者的视觉和解剖学结果，且眼部和非眼部安全事件发生率较低。
方法：177名pmCNV患者以3:1的比例随机分配接受康柏西普或假注射，分别。康柏西普组在3个月的负荷剂量后接受康柏西普玻璃体内注射，以先纳达（PRN）为基础。假手术组接受三个连续的每月假注射，然后接受一次康柏西普注射，然后接受PRN康柏西普玻璃体内注射。
结果：在第3个月，两组的平均BCVA提高了12.0个字母（conbercept组，从54.05个字母到66.05个字母）和0.6个字母（假组，从49.77个字母到50.33个字母)，分别(p<0.001)。两组在3个月时的平均中央视网膜厚度（CRT）下降了62.0μm（康柏西普组，从348.90μm到286.18μm)和4.4μm(假手术组，从347.86μm到343.47μm）（p<0.001）。在第9个月，康柏西普组的平均BCVA提高了13.3个字母，假手术组的平均BCVA提高了11.3个字母。康柏西普组平均CRT降低73.6μm,假手术组降低55.9μm(p<0.001)。最常见的眼部不良事件与玻璃体内注射有关，如结膜出血和眼压升高。
结论：玻璃体内注射0.5mg康柏西普改善了pmCNV患者的视觉和解剖学结果，且眼部和非眼部安全事件发生率较低。
