Department of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Key Laboratory of Ophthalmology and Visual Sciences, Beijing, China.
Department of Ophthalmology, Chinese PLA General Hospital of Central Theater Command, Wuhan, China.
Acta Ophthalmol. 2024 Jun;102(4):e577-e586. doi: 10.1111/aos.15810. Epub 2023 Nov 27.
PURPOSE: 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. CONCLUSION: 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.
目的：评估 0.5mg 康柏西普玻璃体腔内注射治疗病理性近视脉络膜新生血管（pmCNV）的安全性和有效性。
方法：177 例 pmCNV 患者随机分为 3:1 组，分别接受康柏西普或假注射。康柏西普组在 3 个月的负荷剂量后，根据需要（PRN）接受康柏西普玻璃体腔内注射。假注射组连续接受 3 个月的假注射，然后接受 1 次康柏西普注射，随后根据需要（PRN）接受康柏西普玻璃体腔内注射。
结果：在第 3 个月时，两组的平均最佳矫正视力（BCVA）分别提高了 12.0 个字母（康柏西普组，从 54.05 个字母提高到 66.05 个字母）和 0.6 个字母（假注射组，从 49.77 个字母提高到 50.33 个字母）（p<0.001）。两组的平均中央视网膜厚度（CRT）在第 3 个月时分别下降了 62.0μm（康柏西普组，从 348.90μm下降到 286.18μm）和 4.4μm（假注射组，从 347.86μm下降到 343.47μm）（p<0.001）。在第 9 个月时，康柏西普组的平均 BCVA 提高了 13.3 个字母，假注射组提高了 11.3 个字母。康柏西普组的平均 CRT 下降了 73.6μm，假注射组下降了 55.9μm（p<0.001）。最常见的眼部不良事件与玻璃体腔内注射有关，如结膜下出血和眼内压升高。
结论：0.5mg 康柏西普玻璃体腔内注射可改善病理性近视脉络膜新生血管患者的视力和解剖学结果，且眼部和非眼部安全性事件发生率较低。
Drug Des Devel Ther. 2018-2-19
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