NCT07317934招募中3 期
A Phase III, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Subretinal Injection of LX102 in Participants With Neovascular Age-Related Macular Degeneration - The STELLAR Trial
Innostellar Biotherapeutics Co.,Ltd56 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2026年1月14日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 388
- 试验地点
- 56
- 主要终点
- Mean change from D0 in BCVA based on an average at weeks 48 and 56.
研究概览
简要总结
This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 48 and 56.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written, signed informed consent for this study;
- •Age ≥50 and ≤80 years old;
- •Active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
- •The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
- •Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
- •No anti-VEGF therapy in study eye within 28 days before screening;
- •Must be pseudophakic in the study eye.
排除标准
- •Any condition in the investigator's opinion that could limit VA improvement in the study eye.
- •CNV or macular edema in the study eye secondary to any causes other than AMD
- •Subfoveal atrophy in the study eye, as determined by CRC;
- •History of retinal detachment in the study eye at any time;
- •History of idiopathic or autoimmune uveitis in either eye;
- •Advanced glaucoma in the study eye;
- •History of vitrectomy surgery in the study eye;
- •History of intraocular surgery within 1 month before screening in the study eye;
- •History of ocular or systemic gene therapy;
- •Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
研究组 & 干预措施
Aflibercept
Active Comparator
干预措施: Aflibercept (Biological)
LX102
Experimental
干预措施: LX102 (Genetic)
结局指标
主要结局
Mean change from D0 in BCVA based on an average at weeks 48 and 56.
时间窗: Week 56
Mean change from D0 in BCVA as measured by the early treatment diabetic retinopathy study (ETDRS) visual acuity chart based on an average at weeks 48 and 56.
Mean change from D0 in BCVA based on an average at weeks 40 and 48.
时间窗: Weeks 40 and 48
Mean change from D0 in BCVA as measured by the early treatment diabetic retinopathy study (ETDRS) visual acuity chart based on an average at weeks 40 and 48.
次要结局
- Proportion of participants with improved BCVA(Week 56 and week 104)
- Proportion of participants with worsened BCVA(Week 56 and week 104)
- Mean change from D0 in CST based on an average at weeks 48 and 56(Week 56)
- Proportion of participants without SRF/IRF on OCT at week 56(Week 56)
- Proportion of participants who were supplemental anti-VEGF injection-free(Through 56 weeks)
- Proportion of participants who received 1 or 2 aflibercept injections(Through 56 weeks)
- Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 56(Through 56 weeks)
- Incidence of ocular and nonocular AEs and SAEs(56 weeks)
- Immunogenicity characteristics of LX102(56 weeks)
- Proportion of participants with improved BCVA(Week 48)
- Proportion of participants with worsened BCVA(Week 48)
- Mean change from D0 in CST based on an average at weeks 40 and 48(Weeks 40 and 48)
- Proportion of participants without SRF/IRF on OCT at week 48(Week 48)
- Proportion of participants who were supplemental anti-VEGF injection-free(Through 48 weeks)
- Proportion of participants who received 1 or 2 aflibercept injections(Through 48 weeks)
- Supplemental anti-VEGF injection annualized rate after LX102 administration through Week 48(Through 48 weeks)
- Incidence of ocular and nonocular AEs and SAEs(48 weeks)
- Immunogenicity characteristics of LX102(48 weeks)
研究者
研究点 (56)
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