Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study

Ophthalmology Volume 130, Number 9, September 2023

手術、組織纖溶酶原激活劑、抗血管生成藥物和年齡相關性黃斑變性研究

中文摘要

這項研究是一個隨機對照試驗，旨在比較兩種治療次級於新生血管性年齡相關性黃斑變性（neovascular age-related macular degeneration, nAMD）的亞黃斑出血（submacular hemorrhage, SMH）的療效和安全性。比較的兩種方法是手術性的玻璃體切除（PPV）和利用組織纖溶酶原激活劑（tissue plasminogen activator, tPA）和血管內皮生長因子（VEGF）抑制劑進行氣體驅動位移（pneumatic displacement, PD）。該研究包括90名50歲或以上的近期發生SMH的患者。

主要療效終點是3個月時最佳矯正視力（VA）的平均變化，次要終點包括6個月時平均VA的變化、抗VEGF注射次數以及在6個月的追蹤期間的併發症。

該研究得出結論，無論是手術性PPV還是PD，在3個月時對於治療次級於nAMD的SMH的視力增益或其他附加效益並無優越性。兩種治療方法都在6個月的時間內導致視力改善，且沒有明顯的安全性疑慮。但該研究並不是設計用來確立兩種治療方法之間的等效性。

結果表明，相對較不侵入性的PD方法可以考慮作為一個可行的治療選擇，特別是在特定參數未指示其他情況時。該研究還強調，對於SMH患者，脈絡膜新生血管病變在數個月內仍然活躍，需要進行多次抗VEGF注射，不論最初用於治療SMH的方法為何。

English Abstract

The study is a randomized controlled trial aimed at comparing the efficacy and safety of two treatment methods for submacular hemorrhage (SMH) secondary to neovascular age-related macular degeneration (nAMD). The two methods compared were surgical pars plana vitrectomy (PPV) and pneumatic displacement (PD) with tissue plasminogen activator (tPA) and vascular endothelial growth factor (VEGF) inhibitor added to each treatment arm. The study involved 90 patients aged 50 or older with recent SMH.

The primary efficacy endpoint was the mean change in best-corrected visual acuity (VA) at month 3, and secondary endpoints included mean VA change at month 6, the number of anti-VEGF injections, and complications during the 6-month follow-up.

The study concluded that neither surgical PPV nor PD showed superior visual gain or additional benefits for treating SMH secondary to nAMD at the 3-month mark. Both treatment methods led to clinical improvement in visual acuity over a 6-month period without significant safety concerns. The study was not designed to establish equivalence between the two treatment methods.

The results suggest that the less invasive PD approach could be considered a viable treatment option, especially when specific parameters do not indicate otherwise. The study also highlighted that the choroidal neovascularization lesion in patients with SMH remains active for several months, requiring several anti-VEGF injections, regardless of the initial treatment method used for SMH.