玻璃体内地塞米松植入物与玻璃体内雷珠单抗注射治疗非增生性糖尿病性黄斑水肿：前瞻性、随机、盲法试验。

Intravitreal Dexamethasone Implant versus Intravitreal Ranibizumab Injection for Treatment of Non-Proliferative Diabetic Macular Edema: A Prospective, Randomized and Blinded Trial.

机构信息

Department of Ophthalmology, Army Base Hospital and Army College of Medical Sciences, Delhi Cantonment, New Delhi, India.

Department of Ophthalmology, Command Hospital, Lucknow Cantonment, India.

出版信息

Curr Drug Deliv. 2021;18(6):825-832. doi: 10.2174/1567201817666201202093637.

DOI:10.2174/1567201817666201202093637

PMID:33267762

Abstract

INTRODUCTION

In the working age population, Diabetic Macular Edema (DME) is the most common cause of visual loss.

PURPOSE

The present study is aimed to assess the safety and efficacy of intravitreal injection of Ranibizumab (IVR) versus intravitreal Dexamethasone implant (IVD) in patients with DME in a tertiary care centre upto 4 months.

METHODS

This is a comparative, prospective, randomized study that was done on 140 patients with macular edema confirmed on optical coherence tomography (OCT). IVD group received Ozurdex® (Allergan, Inc, Ireland) while the IVR group received Lucentis® (Novartis, Basel, Switzerland); the groups were followed up at day-1 and weeks 4, 8, 12, 16. Patients were divided into Group A, in which patients were given 3 doses (monthly) of IVR 0.3 mg in 0.05 ml (n=70). Group B patients were given a single dose of IVD implant 0.7 mg (n=70).

RESULTS

The mean number of injections given was 1 Ozurdex® per patient vs. 3 Lucentis® per patient. The maximum reduction in central macular thickness (CMT) with IVD was 167.8 μm and 138.8μm in the 2nd and 3rd months, respectively, with IVR. The mean best-corrected visual acuity (BCVA) in the 4th month was 0.34 logMAR and 0.33 logMAR, in IVD and IVR groups, respectively, with consistent improvement. Patients with 0-5 letters, 6-10 letters and 10-15 letters, and >15 letters visibility in IVD group were 9.5, 20.6, 4.8, 6.4%, and 20.4, 18.8, 20.3 20.3% in IVR groups, respectively. The maximum intraocular pressure (IOP) rise with IVD was found to be 16 mmHg in 2 patients (3.17%). IOP rise >10 mmHg was observed in 14/63 patients (22.22%); the majority of patients indicated a high rise at 2nd month with all returning to baseline by 4th month. No reports of infectious endophthalmitis or new cataracts were detected in either of the treated groups.

CONCLUSION

Both intravitreal Ranibizumab injection and Dexamethasone implants were found to be safe and effective in lowering CMT and improving BCVA at the 4-month follow up in patients with DME. Since there was no recurrence of CMT in the Dexamethasone implant group, we suggest that early administration before the 4th month may indicate superior efficacy over the ranibizumab injection. Further randomized trials in a large sample size with a longer period follow- up would be performed to justify the obtained results in the present study.

摘要

简介

在工作年龄段人群中，糖尿病性黄斑水肿（DME）是导致视力丧失的最常见原因。

目的

本研究旨在评估在一家三级护理中心，玻璃体内注射雷珠单抗（IVR）与玻璃体内注射地塞米松植入物（IVD）治疗 DME 患者的安全性和有效性，随访时间长达 4 个月。

方法

这是一项比较性、前瞻性、随机研究，共纳入 140 例经光学相干断层扫描（OCT）证实为黄斑水肿的患者。IVD 组接受奥扎珠单抗（Allergan，Inc，爱尔兰）治疗，而 IVR 组接受雷珠单抗（诺华，巴塞尔，瑞士）治疗；两组均在第 1 天和第 4、8、12、16 周进行随访。患者被分为 A 组和 B 组，A 组患者接受每月 1 次 0.3mg 0.05ml 的 3 次 IVR 治疗（n=70）。B 组患者单次接受 0.7mg 的 IVD 植入物治疗（n=70）。

结果

每位患者接受的平均注射次数为 1 次奥扎珠单抗（IVD）和 3 次雷珠单抗（IVR）。IVD 组第 2 个月和第 3 个月的中央黄斑厚度（CMT）最大减少分别为 167.8μm 和 138.8μm，IVR 组分别为 138.8μm 和 138.8μm。第 4 个月的最佳矫正视力（BCVA）均值分别为 0.34 对数视力和 0.33 对数视力，IVD 和 IVR 组分别为 0.34 对数视力和 0.33 对数视力。在 IVD 组中，0-5 个字母、6-10 个字母、10-15 个字母和>15 个字母视力的患者分别为 9.5%、20.6%、4.8%、6.4%和 20.4%、18.8%、20.3%和 20.3%。在 IVD 组中，有 2 例（3.17%）患者发现最大眼内压（IOP）升高 16mmHg。有 14/63 例（22.22%）患者的 IOP 升高>10mmHg；大多数患者在第 2 个月眼压升高明显，所有患者在第 4 个月眼压均恢复至基线水平。在治疗组中均未发现感染性眼内炎或新发性白内障。