NCT05251636尚未招募3 期
A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 159
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This study is investigating the use of episcleral brachytherapy (ESB) adjunct to aflibercept compared to aflibercept monotherapy for the treatment of polyploid choroidal vasculopathy (PCV) in patients experiencing an inadequate response to anti-VEGF monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active PCV due to nAMD
- •Incomplete response to anti-VEGF
- •Received at least 3 consecutive and sequential anti-VEGF injections (no missed treatments)
- •Ability to undergo ESB intervention
排除标准
- •Sub-retinal fibrosis
- •Type I or Type II diabetes mellitus
- •Previous therapeutic radiation to the head or neck that may have resulted in radiation dose to the retina
- •Study eye with BCVA of worse than 20 ETDRS letters (20/400 Snellen)
- •Fellow eye with worse BCVA than the study eye or other vision-threatening disease not eligible for treatment
- •Receiving anti-VEGF therapy for any reason other than AMD
研究组 & 干预措施
ESB adjunct to IAI
Experimental
Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
干预措施: Episcleral Brachytherapy (Radiation)
ESB adjunct to IAI
Experimental
Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
干预措施: Aflibercept Injection (Drug)
IAI monotherapy
Active Comparator
Intravitreal aflibercept injections (IAI)
干预措施: Aflibercept Injection (Drug)
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: 12 months
次要结局
- Best Corrected Visual Acuity (BCVA)(24 months)
- Central Retinal Thickness(12 and 24 months)
- Lesion size(12 and 24 months)
研究者
相似试验
已完成
3 期
Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma PatientsGlaucoma, NeovascularNCT02396316Bayer54
已完成
3 期
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular EdemaDiabetic Macular EdemaNCT01363440Regeneron Pharmaceuticals466
已完成
3 期
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular EdemaDiabetic Macular EdemaNCT03917472Novartis Pharmaceuticals517
已完成
4 期
Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular DegenerationWet Macular DegenerationNCT02305238Bayer288
已完成
不适用
Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)Diabetic macular edemaJPRN-jRCTs031180356Murata Toshinori15