A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 48
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
研究概览
简要总结
The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
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
- Triple (Participant, 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
- •Males or females of any race at least 50 years of age
- •Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye
- •Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye
排除标准
- •Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye
- •Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
- •Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
- •Vitrectomy in the study eye
- •Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
时间窗: Baseline and Month 3
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
时间窗: Baseline and Month 3
Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.
次要结局
- Change From Baseline in BCVA in the Study Eye at Month 6(Baseline and Month 6)
- Change From Baseline in CST in the Study Eye at Month 6(Baseline and Month 6)