Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 (Razuprotafib)15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 46
- 主要终点
- Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 through 80 years of age (inclusive)
- •Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)
- •No evidence of central involved diabetic macular edema
- •ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)
排除标准
- •Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
- •Evidence of neovascularization on clinical examination or imaging
- •Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
研究组 & 干预措施
Placebo Twice Daily
Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID)
干预措施: Placebo (Drug)
AKB-9778 15mg Daily
AKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo
干预措施: AKB-9778 (Drug)
AKB-9778 15mg Daily
AKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo
干预措施: Placebo (Drug)
AKB-9778 15mg Twice Daily
AKB-9778 15 mg (BID)
干预措施: AKB-9778 (Drug)
结局指标
主要结局
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
时间窗: Baseline to Week 48
Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12
次要结局
- Mean Change From Baseline in DRSS in the Study Eye at Week 48(Week 48)
- Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes)(Treatment Period - 12 months (48 weeks))
- Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.(Treatment Period - 12 months (48 weeks))
- Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation(Treatment Period - 12 months (48 weeks))
- Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48(Baseline to Week 48)
- Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.(Baseline to Week 48)
- Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes)(Treatment Period - 12 months (48 weeks))