NCT06270836已完成3 期
A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Diabetic Retinopathy (DR) - GLOW2
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 76
- 主要终点
- Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
研究概览
简要总结
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.
详细描述
This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.
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, Care Provider, Outcomes Assessor)
盲法说明
To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to participation in the study.
- •Type 1 or 2 diabetes mellitus and HbA1c of ≤12%.
- •DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
- •CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR
- •CST >320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.
排除标准
- •Prior PRP in the Study Eye.
- •Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
- •Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within the last twelve (12) months prior to Day
- •Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day
- •Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
- •History of vitreoretinal surgery in the Study Eye.
- •History of uveitis in either eye.
- •Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
- •Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP.
- •Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study.
- •Active or suspected ocular or periocular infection or inflammation.
- •Women who are pregnant or lactating or intending to become pregnant during the study.
- •History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
- •Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
- •Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Treatment Group B
Sham Comparator
Sham injection on the same schedule as Treatment Group A
干预措施: Sham injection (Other)
Tarcocimab 5 mg (Treatment Group A)
Experimental
Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44.
干预措施: Tarcocimab (Drug)
结局指标
主要结局
Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
时间窗: Day 1 to Week 48
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
次要结局
- Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy(Day 1 to Week 48)
- Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)(Day 1 to Week 48)
研究者
研究点 (76)
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