A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 12
- 主要终点
- Mean change from baseline in BCVA
研究概览
简要总结
This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
详细描述
AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is the main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.
The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.
This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
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
- 50 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;
- •Age ≥ 50 years of either gender;
- •Total lesion size ≤ 30 mm2 of the study eye;
- •BCVA score of the study eye between 73 and 19 letters;
- •Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
- •BCVA score of the fellow eye ≥ 19 letters.
排除标准
- •Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
- •Subretinal hemorrhage area≥ 50% of total lesion size;
- •Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
- •Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
- •Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
- •Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
- •Previous ophthalmologic operations in the study eye;
- •Current active inflammation or infection in either eye;
- •Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
- •Current systemic administrations which may lead to toxicity in the crystalline lens;
- •History of allergy or current allergic response;
- •History of surgery within one month preceding enrollment;
- •Infectious diseases need systemic administration;
- •Systemic autoimmune diseases;
- •Any uncontrolled clinical disorders;
- •Patients of child-bearing potential do not adopted adequate contraception methods;
- •Pregnant or nursing women;
- •Patients should be excluded in the opinion of investigators;
结局指标
主要结局
Mean change from baseline in BCVA
时间窗: at month 3
To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values
次要结局
- The incidence rate of adverse event(at month 3)
- Mean change of retinal thickness from baseline(at month 3)