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


Tags Retina
Journal Ophthalmology
Status 審查完成
校稿者 蕭靜熹 醫師

Ophthalmology Volume 130, Number 9, September 2023



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。




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.