NCT07275840招募中2 期
An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration
Innovent Biologics Technology Limited (Shanghai R&D Center)2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年12月5日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52
研究概览
简要总结
This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have signed an informed consent form before participating in the research.
- •Male or female individuals aged 50 or above at the time of signing the informed consent form;
- •Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
- •At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
排除标准
- •According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results;
- •The study eye has uncontrollable glaucoma;
- •There is an active intraocular or periocular infection or inflammation in either eye;
- •The non-study eye has severe visual function disorders;
- •Within 90 days before baseline, the study eye had received anti-VEGF treatment;
- •Within 90 days before baseline, the study eye had received anti-complement treatment;
- •At any time before baseline, the study eye had received IBI302 treatment;
- •Uncontrollable hypertension;
- •Glycated hemoglobin (HbA1c) > 10.0% within 28 days prior to screening;
- •Other exclusion criteria set by protocol.
研究组 & 干预措施
IBI302 8mg dose 8mg
Experimental
Drug: IBI302 8mg/Intravitreal injection
干预措施: IBI302 8mg dose (Drug)
结局指标
主要结局
Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52
时间窗: Week52
次要结局
- The changes in BCVA from baseline at each visit(Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52)
- Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52(Week52)
- Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52(Week52)
- The change in central subfield thickness of the macula measured by OCT from the baseline at week 52(Week52)
- Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52(Week52)
- Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline(Week52)
- Change in CNV leakage area on FFA at week 52 compared to baseline(Week52)
- Proportion of participants with new-onset MA on OCT at Week 52(Week52)
- Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52(Week52)
- Change in MA area on OCT from baseline at Week 52(Week52)
- Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52(Week52)
- The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE)(From baseline through Week 52)
- The production of anti-drug antibodies in the serum(Day0、Week4、Week16、Week32、Week48、Week52)
研究者
研究点 (2)
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