NCT07489586尚未招募3 期
A Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of QL1207H Injection Versus Eylea® (Aflibercept, 114.3 mg/mL, 8 mg Per 70 μL) in Patients With Neovascular Age-Related Macular Degeneration
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 356
- 主要终点
- Change from baseline in BCVA at Week 12
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of QL1207H injection versus aflibercept 8 mg in patients with neovascular age-related macular degeneration. The main question it aims to answer is:
• Whether the efficacy and safety of QL1207H and aflibercept 8 mg are similar. Participants will receive injection once every 4 weeks for 3 consecutive doses, followed by injection once every 16 weeks at maximum.
Researchers will compare QL1207H group and aflibercept 8 mg group to see if they are similar in improving best corrected visual acuity.
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
- •At least 50 years of age.
- •Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
- •Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
- •Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
- •BCVA ETDRS letter score of 78 to 24 in the study eye.
排除标准
- •Causes of CNV other than nAMD in the study eye.
- •Total lesion size >12 disc areas; or subretinal hemorrhage that is at least 50% of the total lesion area, or if the blood under the fovea is 1 or more disc areas in size in the study eye.
- •Scar, fibrosis, or atrophy involving the central subfield in the study eye.
- •Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with antiglaucoma medication) in the study eye.
- •Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
结局指标
主要结局
Change from baseline in BCVA at Week 12
时间窗: Week 12
次要结局
未报告次要终点
研究者
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