Nemcansky Jan, Stepanov Alexandr, Koubek Michal, Veith Miroslav, Klimesova Yun Min, Studnicka Jan
Department of Ophthalmology, Faculty of Medicine, University of Ostrava and University Hospital Ostrava, Ostrava, Czech Republic.
Department of Ophthalmology, Faculty of Medicine in Hradec Kralove, Charles University in Prague and University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.
J Ophthalmol. 2019 Jun 10;2019:2635689. doi: 10.1155/2019/2635689. eCollection 2019.
To present a cohort of treatment-naive patients with the neovascular form of age-related macular degeneration (nAMD) treated with aflibercept in a fixed regimen and evaluate the treatment response of three types of choroidal neovascular membrane (CNV)-occult (Type 1), classic (Type 2), and minimally classic (Type 4).
This was a multicentre, prospective, observational consecutive case series study. Patients diagnosed with three types of CNV of nAMD were treated in a fixed regimen (3 injections every 4 weeks, and then injections at 8 week intervals). The follow-up period was 48 weeks. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and spectral-domain optical coherence tomography (OCT). The measurements were taken at the baseline and then at 16, 32, and 48 weeks.
The treatment-naive group was composed of 135 eyes of 135 patients in the study. 61 eyes had Type 1 lesions of CNV, 50 eyes had Type 2 lesions, and 24 eyes had Type 4 lesions. Mean baseline BCVA ± SD for Type 1 lesions was 56.1 ± 10.8 ETDRS letters, and then 62.2 ± 12.9 letters, 61.2 ± 13.7 letters, and 62.8 ± 15.1 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD for Type 1 lesions was 442.4 ± 194.9 m, and then 302.5 ± 144.4 m, 299.7 ± 128.5 m, and 277.7 ± 106.5 m at 16, 32, and 48 weeks, respectively. Mean baseline BCVA ± SD for Type 2 lesions was 55.6 ± 9.9 ETDRS letters, and then 62.5 ± 11.1 letters, 60.7 ± 13.0 letters, and 62.5 ± 14.2 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD. For Type 4 lesions mean baseline BCVA ± SD was 56.7 ± 9.0 ETDRS letters, and then 59.1 ± 10.6 letters, 59.5 ± 11.4 letters, and 59.2 ± 12.6 letters at 16, 32, and 48 weeks respectively. Mean baseline CRT ± SD for Type 4 lesions was 492.1 ± 187.0 m, and then 333.3 ± 137.5 m, 354.4 ± 175.0 m, and 326.7 ± 122.4 m at 16, 32, and 48 weeks respectively. All these changes were statistically significant ( < 0.005).
The primary outcome of our study is that the treatment with aflibercept in nAMD patients led to statistically significant improvement in BCVA and to a decrease in CRT throughout the follow-up period in both occult and classic types of CNV. The minimally classic type of CNV demonstrated a poorer functional and anatomical response to treatment.
呈现一组初治的新生血管性年龄相关性黄斑变性（nAMD）患者，他们接受了阿柏西普固定方案治疗，并评估三种类型脉络膜新生血管膜（CNV）——隐匿性（1型）、典型性（2型）和最小典型性（4型）的治疗反应。
这是一项多中心、前瞻性、观察性连续病例系列研究。诊断为nAMD三种类型CNV的患者接受固定方案治疗（每4周注射3次，然后每8周注射一次）。随访期为48周。使用早期糖尿病性视网膜病变研究（ETDRS）视力表和光谱域光学相干断层扫描（OCT）测量最佳矫正视力（BCVA）和中心视网膜厚度（CRT）。在基线以及第16、32和48周进行测量。
研究中的初治组由135例患者的135只眼组成。61只眼有1型CNV病变，50只眼有2型病变，24只眼有4型病变。1型病变的平均基线BCVA±标准差为56.1±10.8 ETDRS字母，在第16、32和48周时分别为62.2±12.9字母、61.2±13.7字母和62.8±15.1字母。1型病变的平均基线CRT±标准差为442.4±194.9μm，在第16、32和48周时分别为302.5±144.4μm、299.7±128.5μm和277.7±106.5μm。2型病变的平均基线BCVA±标准差为55.6±9.9 ETDRS字母，在第16、32和48周时分别为62.5±11.1字母、60.7±13.0字母和62.5±14.2字母。4型病变的平均基线BCVA±标准差为56.7±9.0 ETDRS字母，在第16、32和48周时分别为59.1±10.6字母、59.5±11.4字母和59.2±12.6字母。4型病变的平均基线CRT±标准差为492.1±187.0μm，在第16、32和48周时分别为333.3±137.5μm、354.4±175.0μm和326.7±122.4μm。所有这些变化均具有统计学意义（P<0.005）。
我们研究的主要结果是，在nAMD患者中使用阿柏西普治疗在整个随访期内使BCVA有统计学意义的改善，并且使隐匿性和典型性CNV类型的CRT均降低。最小典型性CNV类型对治疗的功能和解剖学反应较差。
