Nawar Amin E, Shafik Heba M
Department of Ophthalmology, Tanta University, Tanta, Egypt.
BMC Ophthalmol. 2020 Oct 19;20(1):414. doi: 10.1186/s12886-020-01679-4.
Myopic choroidal neovascularization (CNV) is the most common sight-threatening complication associated with high myopia. The present study evaluated the efficacy and safety of the intravitreal injection of ziv-aflibercept in patients with myopic CNV.
This prospective interventional study was conducted on 20 eyes of 20 patients with active myopic CNV. Twelve patients were 40 years or older. This study was performed in the Ophthalmology Department of Tanta University Eye Hospital, Tanta University, Egypt. Optical coherence tomography (OCT) was performed for all patients at baseline and monthly after injection during the 6-month follow up period. The main outcome measures were changes in BCVA and CMT. The exploratory outcome measures were CNV size, IOP and the number of injections needed in each age group during the study period.
Patients with myopic CNV younger than 40 years needed fewer injections (2.00 ± 0.76) than patients older than 40 years (2.50 ± 1.00), with no statistical significance detected between the two groups (p-value 0.246). CNV was smaller in the younger age group (p-value 0.209), best corrected visual acuity (BCVA) improved significantly in the younger and older age groups (p-values 0.001 and 0.028, respectively), and central macular thickness (CMT) decreased significantly after 6 months, from 242.88 ± 23.83 μm to 191.13 ± 13.83 μm in the younger age group and from 251.33 ± 26.60 μm to 197.08 ± 17.64 μm in the older age group (p = 0.001). No significant correlation was found between the final BCVA and either the spherical equivalent or central macular thickness after 6 months, with p-values of 0.135 and 0.145, respectively. No significant changes in IOP were detected in either group after the intravitreal injection.
Ziv-aflibercept is a highly effective and safe drug in cases of active myopic CNV; however, a larger number of patients and a longer follow-up period are needed to confirm our results. This study was retrospectively registered at clinicaltrials.gov (ID: NCT04290195) on 26-2-2020.
近视性脉络膜新生血管(CNV)是高度近视最常见的致盲并发症。本研究评估了玻璃体内注射阿柏西普治疗近视性CNV患者的疗效和安全性。
本前瞻性干预研究对20例活动性近视性CNV患者的20只眼进行。12例患者年龄在40岁及以上。本研究在埃及坦塔大学眼科医院眼科进行。在基线时以及随访6个月期间每月注射后对所有患者进行光学相干断层扫描(OCT)。主要观察指标为最佳矫正视力(BCVA)和中心黄斑厚度(CMT)的变化。探索性观察指标为研究期间各年龄组的CNV大小、眼压及所需注射次数。
40岁以下近视性CNV患者所需注射次数(2.00±0.76)少于40岁以上患者(2.50±1.00),两组间差异无统计学意义(p值0.246)。较年轻年龄组的CNV较小(p值0.209),较年轻和较年长年龄组的最佳矫正视力(BCVA)均显著改善(p值分别为0.001和0.028),6个月后中心黄斑厚度(CMT)显著降低,较年轻年龄组从242.88±23.83μm降至191.13±13.83μm,较年长年龄组从251.33±26.60μm降至197.08±17.64μm(p = 0.001)。6个月后最终BCVA与等效球镜度或中心黄斑厚度之间均未发现显著相关性,p值分别为0.135和0.145。玻璃体内注射后两组眼压均未发现显著变化。
阿柏西普在活动性近视性CNV病例中是一种高效且安全的药物;然而,需要更多患者和更长随访期来证实我们的结果。本研究于2020年2月26日在ClinicalTrials.gov上进行回顾性注册(ID:NCT04290195)。