NCT07841899尚未招募3 期
A Phase 3, Randomized, Double-masked, Multicenter, Active Comparator-controlled Trial to Investigate the Efficacy and Safety of Intravitreal OLN324 in Adult Participants With Diabetic Macular Edema (DME) (ATACAMA)
Ollin Biosciences, Inc.0 个研究点目标入组 450 人开始时间: 2026年10月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 主要终点
- Change in BCVA
研究概览
简要总结
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with diabetic macular edema (DME).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent
- •Be ≥18 years of age.
- •Have type 1 or type 2 diabetes mellitus
- •Have a decrease in vision in the study eye due to diabetic macular edema (DME), with best corrected visual acuity of 78 to 25 letters
- •Have macular edema on OCT with a CST of ≥ 325 µm
- •Participants may be either treatment-naïve or previously-treated for DME in their study eye. The number of previously-treated participants is limited.
- •Additional inclusion criteria apply
排除标准
- •Be pregnant or breastfeeding
- •History of cataract surgery in the study eye within 90 days of Screening
- •Has uncontrolled glaucoma in the study eye
- •Has uncontrolled hypertension
- •Has had a stroke or myocardial infarction within 180 days
- •If in the cohort of previously treated for DME participants, prior treatment with intravitreal bevacizumab, aflibercept, faricimab, ranibizumab, conbercept, or other approved anti-VEGF or Anti-VEGF/Anti-Ang-2 therapies within 90 days of randomization.
- •Additional exclusion criteria apply
研究组 & 干预措施
OLN324
Experimental
干预措施: OLN324 (Drug)
Aflibercept
Active Comparator
干预措施: Aflibercept (Drug)
结局指标
主要结局
Change in BCVA
时间窗: Day 1 to Week 48
Change in ETDRS BCVA eye chart letter score from Day 1 to Week 48.
次要结局
- Mean change in OCT CST in the Study Eye from baseline at Week 20(Day 1 to Week 20)
- Percentage of participants with absence of DME in the Study Eye at Week 20(Day 1 to Week 20)
- Time to DME resolution in the Study Eye(Enrollment through study completion, an average of 2 years)
- Mean change in OCT CST in the Study Eye from baseline at Week 48(Day 1 to Week 48)
- Percentage of participants with absence of DME in the Study Eye at Week 48(Week 48)
研究者
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