A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
研究概览
简要总结
This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Participant is ≥18 years old at the time of signing the ICF.
- •Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.
- •Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.
- •Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.
- •Participant's decrease in vision is determined to be primarily the result of DME in the study eye.
排除标准
- •previous treatment with anti-VEGF therapy
- •history or concurrent disease other than DME that could compromise visual acuity
- •Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
- •participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.
研究组 & 干预措施
AVT29 (proposed aflibercept HD biosimilar)
Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
干预措施: AVT29 (proposed aflibercept HD biosimilar) (Drug)
Eylea HD (aflibercept HD)
Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
干预措施: Eylea HD (aflibercept HD) (Drug)
结局指标
主要结局
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
时间窗: week 8
次要结局
未报告次要终点