Sierra Eye Associates, Reno, NV, USA.
Xintera BV, Ghent, Belgium.
Acta Ophthalmol. 2021 Sep;99(6):e823-e836. doi: 10.1111/aos.14686. Epub 2020 Dec 26.
Effectiveness of ocriplasmin for vitreomacular traction (VMT) varies depending on the presence of common ocular conditions and patient selection criteria. We carried out a systematic literature review and meta-analysis of ocriplasmin studies conducted in real-world settings (RWS) and compared outcomes with those from randomized controlled trials (RCTs).
We included prospective and retrospective studies from RWS documenting effectiveness of ocriplasmin in patients with VMT with or without MH, and RCTs of ocriplasmin versus control. Key end-points were vitreomacular adhesion resolution (VMAR), nonsurgical MH closure, need for vitrectomy and safety. We conducted meta-regression on pooled results to evaluate effects of baseline covariates and study design on outcomes.
Thirty RWS (2402 patients) and 5 RCTs (737 patients) were included epiretinal membrane (ERM) and broad VMA were more prevalent in RCTs. Primary VMAR, vitrectomy and MH closure rates were comparable between RWS and RCTs. Rates of nsVMAR were significantly higher in RWS than RCTs (odds ratio 1.66; 95% confidence interval [CI]: 1.18-2.34). nsVMAR rates were inversely associated with ERM prevalence (odds ratio 0.20; 95% CI: 0.08-0.51). Compared with the recent OASIS trial, RWS reported a higher incidence of new/worsening subretinal fluid cases and less photophobia, photopsia, vitreous floaters, electroretinogram abnormalities and MH progression.
Ocriplasmin was significantly more effective in achieving nsVMAR in RWS than in RCTs. Lower ERM prevalence in RWS was the single significant explanatory variable for this difference. Conclusions on ocriplasmin safety in RWS are limited due to inconsistent reporting.
玻璃体内注射 ocriplasmin 治疗玻璃体黄斑牵引（VMT）的疗效因常见眼部疾病和患者选择标准的不同而有所差异。我们对真实世界研究（RWS）和随机对照试验（RCT）中 ocriplasmin 的研究进行了系统的文献回顾和荟萃分析，并比较了结果。
我们纳入了前瞻性和回顾性研究，记录了 VMT 合并或不合并 MH 的患者接受 ocriplasmin 治疗的疗效，以及 ocriplasmin 与对照组的 RCT。主要终点是玻璃体黄斑粘连的缓解（VMAR）、非手术 MH 闭合、玻璃体切除术的需要和安全性。我们对汇总结果进行了元回归分析，以评估基线协变量和研究设计对结果的影响。
共纳入 30 项 RWS（2402 例患者）和 5 项 RCT（737 例患者）。RCT 中更常见的是内界膜（ERM）和广泛的 VMA。RWS 和 RCT 之间原发性 VMAR、玻璃体切除术和 MH 闭合率相当。RWS 中非手术 VMAR 率明显高于 RCT（优势比 1.66；95%置信区间[CI]：1.18-2.34）。非手术 VMAR 率与 ERM 患病率呈负相关（优势比 0.20；95%CI：0.08-0.51）。与最近的 OASIS 试验相比，RWS 报告了更高的新发/加重的视网膜下液病例发生率和更少的畏光、闪光感、玻璃体漂浮物、视网膜电图异常和 MH 进展。
在 RWS 中，玻璃体内注射 ocriplasmin 治疗 VMT 后达到非手术 VMAR 的效果明显优于 RCT。RWS 中 ERM 患病率较低是导致这种差异的唯一显著解释变量。由于报告不一致，对 RWS 中 ocriplasmin 安全性的结论有限。
