A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 6
- 主要终点
- Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups
研究概览
简要总结
The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).
The secondary objectives of the study are:
- To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
- To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
- To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR
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
- •Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months per the investigator
- •Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
排除标准
- •Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
- •Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA)
- •Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
- •Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or intravitreal (IVT) anti-VEGF treatment in the study eye
- •Any prior intraocular steroid injection in the study eye
- •Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
- •Note: Other inclusion/ exclusion criteria apply
研究组 & 干预措施
Dosing regimen 1
Participants will receive IVT aflibercept dosing regimen 1
干预措施: Intravitreal aflibercept injection [IAI] (Drug)
Dosing regimen 2
Participants will receive IVT aflibercept dosing regimen 2
干预措施: Intravitreal aflibercept injection [IAI] (Drug)
Dosing regimen 3
Participants will receive matching sham injections
干预措施: Sham (Drug)
结局指标
主要结局
Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups
时间窗: At Week 24
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline.
Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
时间窗: At Week 52
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 52 from baseline.
次要结局
- Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52(At Week 52)
- Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52(At Week 52)
- Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52(At Week 52)
- Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52(Baseline through week 52 (day 365))
- Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52(Baseline through week 52 (day 365))
- Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52(At week 52)