Department of Ophthalmology, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory of Orbital Disease and Ocular Oncology, Shanghai, China.
Acta Ophthalmol. 2020 Nov;98(7):e795-e800. doi: 10.1111/aos.14386. Epub 2020 Feb 29.
Intraoperative subretinal anti-vascular endothelial growth factor (VEGF) injections have been used clinically in some case, but the pharmacokinetic characteristics have not yet been determined. In this pilot study, we investigate the pharmacokinetic parameters of anti-VEGF agents by intraoperative subretinal or intravitreal injection in silicone oil (SiO)-filled eyes of patients with proliferative diabetic retinopathy (PDR).
Randomized controlled trial including 13 patients (16 eyes) with PDR underwent pars plana vitrectomy (PPV) with SiO tamponade and randomly received a subretinal (8 eyes) or intravitreal (8 eyes) conbercept injection (0.5 mg/0.05 ml) intraoperatively. Aqueous humour (AH) was obtained on the 1st, 3rd, 7th, 10th, 14th, 21st and 28th day after the injection. Drug concentrations in the AH were determined by enzyme-linked immunosorbent assay (ELISA). The last best-corrected visual acuity (BCVA) was examined 6 months postoperatively.
The clearance rate of anti-VEGF agents by subretinal injection was reduced in vitrectomized eyes with SiO tamponade (p < 0.05). With the same drug dose, subretinal injection (5.49 ± 6.11 μg/ml) resulted in higher drug concentrations in the AH when compared with intravitreal injection (0.42 ± 0.46 μg/ml, p = 0.001) 4 weeks after the treatment. The mean residence time last (MRT ) by subretinal injection (11.57 ± 0.83 days) was significantly longer than the mean MRT by intravitreal injection (7.10 ± 1.00 days, p < 0.001). A self-paired analysis showed that subretinal injection led to the BCVA improvement by +28.59 letters 6 months postoperatively (p = 0.028) while the BCVA did not improve significantly by intravitreal injection (p = 0.715).
The drug maintenance phase was prolonged by intraoperative subretinal injection in SiO-filled eyes of PDR. The results suggest that subretinal injection might be a valuable treatment option for the management of PDR.
术中眼内视网膜下抗血管内皮生长因子（VEGF）注射已在一些病例中临床应用，但药代动力学特征尚未确定。在这项初步研究中，我们通过对增生性糖尿病视网膜病变（PDR）患者硅油（SiO）填充眼行玻璃体切除术（PPV）并随机接受眼内视网膜下（8 眼）或玻璃体内（8 眼）康柏西普注射（0.5mg/0.05ml），来研究抗 VEGF 药物的药代动力学参数。
一项包括 13 名（16 只眼）PDR 患者的随机对照试验接受了 PPV 联合 SiO 填充，并随机接受了眼内视网膜下（8 只眼）或玻璃体内（8 只眼）康柏西普注射（0.5mg/0.05ml）。在注射后第 1、3、7、10、14、21 和 28 天采集房水（AH）。通过酶联免疫吸附试验（ELISA）测定 AH 中的药物浓度。术后 6 个月检查最后最佳矫正视力（BCVA）。
在玻璃体切除联合 SiO 填充的眼中，眼内视网膜下注射的抗 VEGF 药物清除率降低（p<0.05）。在相同药物剂量下，眼内视网膜下注射（5.49±6.11μg/ml）在治疗后 4 周时导致 AH 中药物浓度高于玻璃体内注射（0.42±0.46μg/ml，p=0.001）。眼内视网膜下注射的平均最后（MRT）为 11.57±0.83 天，明显长于玻璃体内注射的平均 MRT（7.10±1.00 天，p<0.001）。自身配对分析显示，眼内视网膜下注射术后 6 个月可使 BCVA 提高+28.59 个字母（p=0.028），而玻璃体内注射则不能显著提高 BCVA（p=0.715）。
在 PDR 的 SiO 填充眼中，术中眼内视网膜下注射延长了药物维持期。结果表明，眼内视网膜下注射可能是治疗 PDR 的一种有价值的治疗选择。
