An Open Label, Multicenter, Randomized, Uncontrolled Study Assessing the Safety and Efficacy of KH902 in Patients With Choroidal Neovascularization Due to Neovascular Age-related Macular Degeneration(HOPE Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- The incidence rate of adverse event
研究概览
简要总结
This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.
详细描述
Due to conclusions of KH902 Ia study:
Doses of single intravitreal injection of a recombinant human VEGF receptor-Fc fusion protein (KH902) in patients with CNV secondary to neovascular AMD are from 0.05 mg to 3.0 mg. The trial shows that KH902 is safe and tolerable, and no DLT, ophthalmia reaction, endophthalmitis, or systemic AE relevant to the drug is reported, and the main AEs are transient ocular tension increase and micro-hemorrhage in injection site. KH902 appears to produce rapid clinical effects on VA, supported by improvements in anatomical features, in patients with neovascular AMD.
HOPE Study is an open label, multi-center, randomized, uncontrolled dose-and interval-ranging phase Ib study designed to assess the efficacy and safety of multiple intravitreal injection of KH902 at variable dosing regimen in patients with CNV due to AMD. Two groups of patients will initially receive intravitreal administration of KH902 following the randomization:
- Patients in group A will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 0.5 mg/50 μl/eye;
- Patients in group B will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 2.0 mg/50 μl/eye.
Following the initial 12-week fixed-dosing phase of the trial:
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the Informed Consent Form by patients or legal representative;
- •Men and women ≥ 45 years of age;
- •Active primary or recurrent lesions with CNV secondary to neovascular AMD;
- •Total lesion size ≤ 12 disc areas in either eye;
- •BCVA of the study eyes < 69 letters and the BCVA of fellow eyes ≥ 19 letters;
- •Clear ocular media and adequate pupil dilation.
排除标准
- •CNV lesion secondary to ocular conditions other than neovascular AMD
- •History of vitreous hemorrhage, retinal tear, rhegmatogenous retinal detachment or macular hole in the study eye;
- •Presence of retinal detachment, retinal pigment epithelial tear, or retinal macular traction in the study eye;
- •Anaphylactic disease;
- •Uncontrolled glaucoma in either eye;
- •Current active ocular inflammation or infection in either eye;
- •Previous anti-VEGF drug treatment in the study eye within three months preceding screening, and/or, for the fellow eye, within one month preceding screening;
- •Previous ophthalmologic operation or laser therapy in the study eye within three months preceding screening;
- •Current non-healing wound, ulcer, fractures, etc;
- •Uncontrolled systemic conditions;
- •Patients of child-bearing potential do not adopted adequate contraception methods;
- •Pregnant or nursing women.
研究组 & 干预措施
Group A
Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52
干预措施: Intravitreal injection of KH902 (Biological)
Group B
Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52
干预措施: Intravitreal injection of KH902 (Biological)
结局指标
主要结局
The incidence rate of adverse event
时间窗: at 52 week
To evaluate the safety of multiple intravitreal injection of KH902 of each group.
次要结局
- Change from Baseline in BCVA(Specified timepoints during the screening phase and 52-week treatment period)