A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 17
- 主要终点
- To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
研究概览
简要总结
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).
详细描述
This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily [b.i.d.]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (NPDR) to severe NPDR.
Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2
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
- •Age ≥ 18 years.
- •Type 1 or type 2 DM.
- •BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
- •Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).
排除标准
- •Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
- •PRP or grid laser within 1000 microns of the foveal center.
- •Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
- •Prior Intraocular of periocular steroid Injection
- •Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
- •History of vitreoretinal surgery.
- •History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- •History of DME or DR treatment with laser or intraocular injections of medication.
- •Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
- •Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
- •Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
- •Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.
研究组 & 干预措施
AKST4290
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
干预措施: AKST4290 (Drug)
Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
时间窗: Baseline to Week 24
The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR. To be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline. The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings. The primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24.
次要结局
- To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.(Baseline to Week 24 or 28)
- To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.(Baseline to Week 28)
- To Assess the Overall Safety of AKST429(Baseline to Week 28)
- To Assess the Effect of AKST4290 on Diabetic Kidney Disease(Baseline to Week 28)
- To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.(Baseline to Week 24)
- To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV).(Baseline to Week 28)