A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (Wet AMD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 14
- 主要终点
- Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
研究概览
简要总结
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
详细描述
This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.
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
- Double (Participant, Investigator)
盲法说明
This study is double-masked, masking patients and investigators to treatment assignment. In addition to this, any Clinical Research Organization and Sponsor team members who are actively engaged with the site will be masked.
The injector will be unmasked. Some additional roles at the site, Clinical Research Organization and Sponsor levels are unmasked.
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
- •Patients aged ≥50 years.
- •Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
- •BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
- •Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.
排除标准
- •Concurrent disease in the study eye or structural damage, other than wet AMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye.
- •Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening
- •Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
- •History of vitreous hemorrhage in the study eye within 2 months prior to Screening
- •Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
- •Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
研究组 & 干预措施
UBX1325
干预措施: UBX1325 injection 50 μL (Drug)
Aflibercept (EYLEA ®)
干预措施: EYLEA® (aflibercept) Injection 2 mg (0.05mL) (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control
时间窗: Through 24 weeks
Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24
次要结局
- Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time(Through 48 weeks)
- Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center(Through 48 weeks)
- Adverse Events (Safety)(Through 48 weeks)