Abdin Alaa Din, Mohamed Asem, Munteanu Cristian, Weinstein Isabel, Langenbucher Achim, Seitz Berthold, Suffo Shady
Department of Ophthalmology, Saarland University Medical Center UKS, Homburg/Saar, Germany.
Department of Ophthalmology, Westpfalz Hospital, Kaiserslautern, Germany.
Int J Retina Vitreous. 2021 Dec 7;7(1):74. doi: 10.1186/s40942-021-00349-x.
To assess the morphological and functional outcome of intravitreal aflibercept following the treat and extend protocol compared to the fixed protocol for treatment of eyes with neovascular age-related macular degeneration.
This retrospective study included 126 eyes of 113 patients with primary onset neovascular age-related macular degeneration who were followed for 12 months. All eyes were treated with 2 mg/0.05 mL aflibercept. All eyes received an upload with three monthly aflibercept injections. We subsequently studied two groups of eyes. For group 1, 54 eyes were treated following the treat and extend protocol. For group 2, 72 eyes were treated following the fixed protocol (fixed 2-monthly interval). Main outcome measures included: best corrected visual acuity (BCVA), central macular thickness (CMT) and number of injections.
BCVA (logMAR) in group 1 vs group 2 was (0.61 ± 0.3 vs 0.72 ± 0.3, p = 0.09) before treatment and (0.48 ± 0.3 vs 0.51 ± 0.3, p = 0.6) after one year of treatment. CMT in group 1 vs group 2 was (371 ± 101 μm vs 393 ± 116 μm, p = 0.5) before treatment and (284 ± 60 μm vs 290 ± 67 μm, p = 0.1) after one year of treatment. Number of injections/eye in group 1 vs group 2 was (8.5 ± 2.2 vs 7.0 ± 0, p < 0.001).
Significant differences regarding BCVA and central macular thickness were not found between both treatment protocols during the first year of treatment using aflibercept. However, a significantly higher number of injections was needed for eyes in the treat and extend group during the first year of treatment. This might suggest that aflibercept should better not be extended past an 8 weeks interval during the first year of treatment.
This study was approved by the Ethics Committee of the Medical Association of Saarland, Germany (Nr. 123/20, Date: 16.06.2020). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
评估与固定方案相比，采用“治疗并延长”方案玻璃体内注射阿柏西普治疗新生血管性年龄相关性黄斑变性眼睛的形态学和功能结局。
这项回顾性研究纳入了113例初发新生血管性年龄相关性黄斑变性患者的126只眼睛，随访12个月。所有眼睛均接受2mg/0.05mL阿柏西普治疗。所有眼睛均接受初始每月3次阿柏西普注射。随后我们研究了两组眼睛。对于第1组，54只眼睛按照“治疗并延长”方案治疗。对于第2组，72只眼睛按照固定方案（固定每2个月间隔）治疗。主要结局指标包括：最佳矫正视力（BCVA）、中心黄斑厚度（CMT）和注射次数。
治疗前第1组与第2组的BCVA（logMAR）分别为（0.61±0.3对0.72±0.3，p = 0.09），治疗1年后分别为（0.48±0.3对0.51±0.3，p = 0.6）。治疗前第1组与第2组的CMT分别为（371±101μm对393±116μm，p = 0.5），治疗1年后分别为（284±60μm对290±67μm，p = 0.1）。第1组与第2组每只眼睛的注射次数分别为（8.5±2.2对7.0±0，p < 0.001）。
在使用阿柏西普治疗的第一年，两种治疗方案在BCVA和中心黄斑厚度方面未发现显著差异。然而，在治疗的第一年，“治疗并延长”组的眼睛需要显著更多的注射次数。这可能表明在治疗的第一年，阿柏西普最好不要超过8周的间隔进行延长治疗。
本研究经德国萨尔州医学协会伦理委员会批准（编号123/20，日期：2020年6月16日）。在涉及人类参与者的研究中进行的所有程序均符合机构和/或国家研究委员会的伦理标准以及1964年《赫尔辛基宣言》及其后续修订版或类似的伦理标准。本文不包含任何作者进行的动物研究。
