Holekamp Nancy M, Yaqub Manejeh, Ranade Shrirang V, Cantrell Ronald A, Singh Sheena, Gazzard Gus
Pepose Vision Institute, Chesterfield, MO, USA.
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Ophthalmol Ther. 2024 Sep;13(9):2303-2329. doi: 10.1007/s40123-024-01001-1. Epub 2024 Aug 1.
To determine whether the types and rates of post-surgical complications associated with the Port Delivery System with ranibizumab (PDS) are comparable with those reported for other ocular implants that cross the sclera.
Systematic literature reviews were conducted to determine the long-term (≥ 18-month) safety of ocular implants that cross the sclera in clinical trials and real-world studies. Complication types and rates were compared with those reported for the PDS in phase III clinical trials (Archway, Pagoda, and Pavilion).
Sixteen clinical trials (24 publications) and 43 real-world studies were identified reporting 30 complications in eyes with 15 implant types and 8 ocular diseases. Implants were associated with an acceptable, well-characterized safety profile, with most complications resolving spontaneously or with treatment. Device-related complications were reported in 0.7% (0.0-5.0%) of study eyes in clinical trials and 1.3% (0.0-14.5%) of eyes in real-world studies. Rates of conjunctival complications were 2.1% (0.0-22.8%) and 2.2% (0.9-4.6%), respectively. The overall types and rates of adverse events of special interest reported for the PDS in phase III trials (cataract, conjunctival bleb, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, endophthalmitis, implant dislocation, retinal detachment, and hyphema) were within the ranges reported for other ocular implants.
The rates of complications reported in phase III clinical trials for the PDS were within the ranges reported for other ocular implants that cross the sclera. This suggests that the long-term safety of the PDS is consistent with other ocular devices established in ophthalmology clinical practice.
PROSPERO international prospective register of systematic reviews: CRD5202234129, CRD42022343129.
确定雷珠单抗眼内植入系统（PDS）相关的术后并发症类型和发生率是否与其他穿透巩膜的眼内植入物报告的情况相当。
进行系统的文献综述，以确定在临床试验和真实世界研究中穿透巩膜的眼内植入物的长期（≥18个月）安全性。将并发症类型和发生率与PDS在III期临床试验（拱门、宝塔和展馆）中报告的情况进行比较。
确定了16项临床试验（24篇出版物）和43项真实世界研究，报告了15种植入物类型和8种眼部疾病的眼中出现30种并发症。植入物具有可接受的、特征明确的安全性，大多数并发症可自发缓解或通过治疗解决。在临床试验中，0.7%（0.0 - 5.0%）的研究眼报告了与器械相关的并发症，在真实世界研究中为1.3%（0.0 - 14.5%）。结膜并发症的发生率分别为2.1%（0.0 - 22.8%）和2.2%（0.9 - 4.6%）。PDS在III期试验中报告的特别关注的不良事件的总体类型和发生率（白内障、结膜下积液、玻璃体积血、结膜糜烂、结膜退缩、眼内炎、植入物脱位、视网膜脱离和前房积血）在其他眼内植入物报告的范围内。
PDS在III期临床试验中报告的并发症发生率在其他穿透巩膜的眼内植入物报告的范围内。这表明PDS的长期安全性与眼科临床实践中确立的其他眼内器械一致。
国际系统评价前瞻性注册库PROSPERO：CRD5202234129，CRD42022343129。
