A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular AgeRelated Macular Degeneration

Ophthalmology Volume 130, Number 6, June 2023

中文摘要

本研究旨在評估OPT-302與anti-VEGF-A inhibitor ranibizumab 聯合治療新生血管型年齡相關性黃斑變性（nAMD）的安全性和療效。試驗納入了未接受治療的nAMD成年患者，評估了視力和光學相干斷層掃描（OCT）測量結果，以及視網膜內和視網膜下液的變化。結果顯示，添加2.0 mg OPT-302到ranibizumab 與安慰劑組相比，在視力方面顯著改善。聯合治療表現出更優異的視力增益，並且安全性與對照組相比可比。這些結果表明，OPT-302與拉尼布注射劑的聯合應用可能為nAMD患者提供潛在的治療選擇。

English Abstract

This study aimed to evaluate the safety and efficacy of OPT-302, a biologic inhibitor of VEGF-C and VEGF-D, in combination with the anti-VEGF-A inhibitor ranibizumab, for the treatment of neovascular age-related macular degeneration (nAMD). It’s a dose-ranging, phase 2b, randomized, double-masked, sham-controlled trial. Participants were randomized to 6, 4-weekly, intravitreal injections of 0.5 mg OPT-302, 2.0 mg OPT-302, or sham, plus intravitreal 0.5 mg ranibizumab. The trial enrolled adults with treatment-naive nAMD and assessed visual acuity outcomes (primary outcome), spectral-domain OCT measurements, and changes in intraretinal and subretinal fluid (secondary outcomes). The results showed that the addition of 2.0 mg OPT-302 to ranibizumab significantly improved visual acuity compared to the sham group. The combination therapy demonstrated superior gains in visual acuity, and the safety profile was comparable to the control group. These findings suggest that 2.0 mg OPT-302 in combination with ranibizumab may offer a potential treatment option for patients with nAMD.