Valverde-Megías Alicia, Ruiz-Calvo Aurora, Murciano-Cespedosa Antonio, Hernández-Ruiz Samuel, Martínez-de-la-Casa Jose María, García-Feijoo Julián
Ophthalmology Unit, Hospital Clínico San Carlos, Insituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Ophtalmology Department, San Carlos Clinical Hospital, c/ Profesor Martin Lagos s/n, 28040, Madrid, Spain.
Graefes Arch Clin Exp Ophthalmol. 2019 Jul;257(7):1459-1466. doi: 10.1007/s00417-019-04325-y. Epub 2019 May 3.
To investigate long-term effect (96 months) of intravitreal ranibizumab administered for exudative age-related macular degeneration (AMD) on retinal nerve fiber layer (RNFL) thickness when used following a pro re nata regimen.
In this prospective study, 20 eyes of 20 patients diagnosed with exudative AMD were included. Contralateral non-exudative AMD eyes of nine of these patients were included as controls. Data on intraocular pressure (IOP) and number of injections were recorded. Spectralis optic coherence tomography (OCT) of the circumpapillary RNFL was performed under dilation when diagnosis was made and before the three loading injections. "Follow-up" software was selected to accurately compare baseline with subsequent images through the 8 years of the study.
Baseline IOP was 14.1 mmHg both in study (standard deviation, SD: 0.8) and control eyes (SD: 0.9) and remained unchanged during the study. Mean number of injections was 21 (SD: 2.8) at the end of the study. Mean average thickness of RNFL in the study eye group at the end of the study was 96.5 μm (SD: 2.1). Mean loss for the study period was 5.3 μm (SD: 0.7; p < 0.0001). Corresponding RNFL values for controls were 92.9 (SD: 3.2) and 5.8 μm (SD: 1.2; p < 0.001). Superior temporal sector had the greatest loss in both groups, followed by inferior and nasal sectors. No statistically significant differences were found when comparing losses in injected eyes versus control eyes.
RNFL thickness decreased both equally in injected eyes and control eyes. Thus, no long-term effects of intravitreal ranibizumab were observed on the retinal nerve fiber layer thickness.
探讨按需给药方案下玻璃体内注射雷珠单抗治疗渗出性年龄相关性黄斑变性（AMD）96个月对视网膜神经纤维层（RNFL）厚度的长期影响。
在这项前瞻性研究中，纳入了20例被诊断为渗出性AMD患者的20只眼。其中9例患者的对侧非渗出性AMD眼作为对照。记录眼压（IOP）和注射次数数据。在确诊时和三次负荷注射前散瞳状态下进行视乳头周围RNFL的Spectralis光学相干断层扫描（OCT）。选择“随访”软件以在研究的8年中准确比较基线与后续图像。
研究组（标准差，SD：0.8）和对照组（SD：0.9）的基线眼压均为14.1 mmHg，在研究期间保持不变。研究结束时平均注射次数为21次（SD：2.8）。研究眼组在研究结束时RNFL的平均厚度为96.5μm（SD：2.1）。研究期间的平均损失为5.3μm（SD：0.7；p＜0.0001）。对照组相应的RNFL值分别为92.9（SD：3.2）和5.8μm（SD：1.2；p＜0.001）。两组中颞上象限损失最大，其次是颞下和鼻侧象限。比较注射眼与对照眼的损失时未发现统计学上的显著差异。
注射眼和对照眼中RNFL厚度均同等程度下降。因此，未观察到玻璃体内注射雷珠单抗对视网膜神经纤维层厚度有长期影响。
