A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 62
- 主要终点
- The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area
研究概览
简要总结
This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
- •Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye
- •Clinical diagnosis of GA secondary to AMD:
- •Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
- •If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
- •Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye
排除标准
- •GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
- •Any history of or active choroidal neovascularization (CNV)
- •Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
研究组 & 干预措施
NGM621 Treatment Group A (every 4 weeks)
NGM621 single intravitreal (IVT) injection
干预措施: NGM621 (Biological)
NGM621 Treatment Group C (every 8 weeks)
NGM621 single IVT injection
干预措施: NGM621 (Biological)
Sham Group B (every 4 weeks)
Sham single IVT injection
干预措施: Sham Comparator (Other)
Sham Group D (every 8 weeks)
Sham single IVT injection
干预措施: Sham Comparator (Other)
结局指标
主要结局
The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area
时间窗: Baseline to Week 52
The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye
时间窗: Baseline to end of study (Week 56)
A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment.
次要结局
- The Change From Baseline in Geographic Atrophy (GA) Lesion Area(Baseline up to Week 52)
- The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area(Baseline up to Week 52)
- The Change From Baseline in Best Corrected Visual Acuity Score(Baseline up to Week 52)
- The Change From Baseline in Low Luminance Visual Acuity Score(Baseline up to Week 52)
- The Change From Baseline in Low Luminance Deficit Score(Baseline up to Week 52)
- The Change From Baseline in Average Binocular Reading Speed(Baseline up to Week 52)
- The Change From Baseline in Binocular Critical Print Size(Baseline up to Week 52)
- The Change From Baseline in Binocular Reading Acuity(Baseline up to Week 52)
- The Change From Baseline in Functional Reading Independence Index Composite Score(Baseline up to Week 52)
- The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score(Baseline up to Week 52)
- The Change From Baseline in Systemic Complement Activity (CH50)(Baseline up to Week 52)
- Number of Anti-Drug Antibody (ADA)-Negative Participants(Baseline up to Week 52)