NCT05972473进行中（未招募）3 期
A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects with Neovascular Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.
研究概览
简要总结
The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
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
- •Signed informed consent must be obtained prior to study participation;
- •Male or female ≥ 50 years of age at the time of signing the informed consent;
- •Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;
- •BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.
排除标准
- •Ocular disease:
- •Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results;
- •Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)> 12 optic disc area (DA) on FFA;
- •Subretinal hemorrhage area > 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA;
- •Fibrosis or atrophy area > 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment);
- •Presence of active intraocular or periocular infection or inflammation;
- •Ocular treatment:
- •Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline;
- •Fundus laser photo-coagulation in the study eye within 90 days prior to baseline;
- •Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline;
- •History of vitreoretinal surgery, penetrating keratoplasty in the study eye;
- •General condition or treatment:
- •Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after standard treatment);
- •HbA1c > 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline;
- •History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine;
- •Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.
研究组 & 干预措施
Aflibercept
Active Comparator
Drug: Aflibercept 2mg/eye; Intraocular injection
干预措施: Aflibercept Ophthalmic (Drug)
IBI302 dose 8mg
Experimental
Drug: IBI302 8mg/eye; Intraocular injection
干预措施: IBI302 (Biological)
结局指标
主要结局
Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.
时间窗: At week 44, 48, 52
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.
次要结局
- The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16(At week 16)
- Change from baseline in BCVA at Week 52 and 100(Upto Week 100)
- Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100(Upto Week 100)
- Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100(Upto Week 100)
- Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100(Upto Week 100)
- Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).(Upto Week 100)
研究者
研究点 (1)
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