Port Delivery System Vs Monthly Ranibizumab in VEGF-Driven Macular Disease: A Systematic Review and Meta-Analysis.

IF 3.1 4区医学 Q2 OPHTHALMOLOGY

Seminars in Ophthalmology Pub Date : 2026-06-26 DOI:10.1080/08820538.2026.2693751

Edhem Dogru, Matheus Pedrotti Chavez, Otávio Toth, Mirella Serafini, Melis Kabaalioglu Guner

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引用次数: 0

Abstract

Purpose: The comparative efficacy and safety of ranibizumab Port Delivery System (PDS) vs monthly intravitreal ranibizumab in Vascular Endothelial Growth Factor (VEGF)-driven macular diseases remains uncertain. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing PDS vs monthly ranibizumab in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

Methods: PubMed, Embase, and Cochrane were searched for randomized controlled trials enrolling adults with neovascular age-related macular degeneration or diabetic macular edema treated with the ranibizumab Port Delivery System (100 mg/mL) versus monthly intravitreal ranibizumab 0.5 mg. This systematic review and meta-analysis was conducted according to a predefined PICOTT framework. Continuous and binary outcomes were pooled with mean differences (MDs) and risk ratios (RRs) with a 95% confidence interval (CI), respectively, with a random-effects model. Statistical analyses were performed using RevMan.

Results: Three trials were included, with a total of 1,149 eyes of which 688 (60%) received PDS and 461 (40%) received monthly ranibizumab. No significant differences were observed in BCVA (nAMD: MD - 0.69 letters; 95% CI - 2.52 to 1.14; p = .46; DME: MD 0.20; 95% CI - 1.20 to 1.60; p = .78) or CRT (nAMD: MD 26.67 µm; 95% CI - 16.55 to 69.88; p = .23; DME: MD - 3.80; 95% CI - 17.20 to 9.60; p = .58). Incidence of ocular AEs was significantly higher with PDS (RR 1.80; 95% CI 1.49-2.17; p < .00001; I²=74%). Among specific complications, conjunctival bleb or filtering bleb leak (RR 15.29; 95% CI 2.31-101.35; p = .005), conjunctival erosion (RR 8.87; 95% CI 1.66-47.35; p = .01), vitreous hemorrhage (RR 3.61; 95% CI 1.24-10.49; p = .02), hyphema (RR 5.77; 95% CI 1.03-32.20; p = .05), and conjunctival retraction (RR 5.78; 95% CI 1.04-32.29; p = .05) occurred significantly more often with PDS. Systemic AEs were comparable between treatment arms (RR 1.00; 95% CI 0.89-1.13; p = .98).

Conclusion: In this systematic review and meta-analysis of three randomized controlled trials, PDS was associated with visual and anatomical results comparable to monthly ranibizumab in patients with nAMD. Evidence in DME was limited to a single trial, and conclusions in this population should be considered exploratory. PDS was associated with a higher incidence of procedure- and device-related ocular complications.

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港口给药系统Vs每月雷尼单抗治疗vegf驱动的黄斑疾病：系统回顾和荟萃分析

目的：在血管内皮生长因子（VEGF）驱动的黄斑疾病中，雷尼单抗港口给药系统（PDS）与每月玻璃体内注射雷尼单抗的疗效和安全性的比较尚不确定。我们对随机对照试验（rct）进行了系统回顾和荟萃分析，比较PDS和每月雷尼单抗治疗新生血管性年龄相关性黄斑变性（nAMD）或糖尿病性黄斑水肿（DME）。方法：PubMed， Embase和Cochrane检索了随机对照试验，纳入了接受雷尼单抗Port给药系统（100mg /mL）治疗的新生血管性年龄相关性黄斑变性或糖尿病性黄斑水肿的成年人，与每月0.5 mg雷尼单抗玻璃体内注射治疗的对照。本系统综述和荟萃分析是根据预定义的PICOTT框架进行的。采用随机效应模型，将连续和二元结果分别与平均差异（md）和风险比（rr）合并，其置信区间（CI）为95%。采用RevMan软件进行统计分析。结果：纳入3项试验，共1149只眼睛，其中688只（60%）接受PDS治疗，461只（40%）每月接受雷尼单抗治疗。BCVA无显著差异(nAMD: MD - 0.69字母；95% CI - 2.52 ~ 1.14; p = 0.46; DME: MD 0.20; 95% CI - 1.20 ~ 1.60; p =。78)或CRT (nAMD: MD 26.67µm; 95%可信区间,16.55至69.88;p = 23;测距装置:MD - 3.80; 95%可信区间,17.20至9.60;p = 58)。PDS患者眼部不良事件发生率显著高于PDS患者（RR 1.80; 95% CI 1.49-2.17; p 2=74%）。在特殊并发症中，结膜泡或滤过泡渗漏(RR 15.29; 95% CI 2.31-101.35; p =。005)，结膜糜烂(RR 8.87; 95% CI 1.66-47.35; p =。0.01)，玻璃体出血(RR 3.61; 95% CI 1.24-10.49; p =。2002)、前房积血(RR 5.77; 95% CI 1.03-32.20; p =。0.05)，结膜内收(RR 5.78; 95% CI 1.04-32.29; p =。PDS患者更常发生（0.05）。两组间系统ae具有可比性（RR 1.00; 95% CI 0.89-1.13; p = 0.98）。结论：在这项对3项随机对照试验的系统回顾和荟萃分析中，PDS与nAMD患者的视觉和解剖学结果相关，与每月使用雷尼单抗相当。二甲醚的证据仅限于单一试验，该人群的结论应被视为探索性的。PDS与手术和器械相关的眼部并发症的发生率较高有关。

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来源期刊

Seminars in Ophthalmology OPHTHALMOLOGY-

CiteScore

3.20

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Seminars in Ophthalmology offers current, clinically oriented reviews on the diagnosis and treatment of ophthalmic disorders. Each issue focuses on a single topic, with a primary emphasis on appropriate surgical techniques.