Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
- 试验地点
- 25
- 主要终点
- Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
研究概览
简要总结
OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.
详细描述
OPL-0401-201 is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with NPDR or mild PDR with or without 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)
盲法说明
This is a double-masked study in which participants, care providers, central reading center and investigators are masked to study intervention.
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
- 未提供
排除标准
- •Body mass index ≥ 45 kg/m2
- •Uncontrolled diabetes mellitus such as hemoglobin A1c (HbA1C) > 11% or patients who are not currently treated for their diabetes;
- •Uncontrolled hypertension defined as systolic > 160mmHg or diastolic > 100 mmHg (despite hypertensive medication);
- •Proliferative Diabetes Retinopathy (PDR) with the exception of mild PDR (DRSS 61);
- •Evidence of retinal neovascularization (with the exception of mild PDR);
- •Any previous Diabetic Retinopathy treatment with focal or grid laser photocoagulation or Pan-Retinal Photocoagulation (PRP);
- •History of previously treated DME with fluocinolone acetonide implant (Iluvien®) injection;
- •Visual acuity loss due to an ocular condition that would not improve from treatment of DR or resolution of DME (i.e., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition);
- •History of vitreoretinal surgery;
- •Intraocular surgery in the study eye within 3 months of randomization or anticipated over the course of the study;
- •Uncontrolled glaucoma (e.g. visual field loss or defined as (IOP) ≥ 25 mmHg despite treatment with anti-glaucoma medication);
- •Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye /any intraocular inflammation or infection in either eye within 3 months prior to randomization.
研究组 & 干预措施
OPL-0401 Dose 1
Participants are randomized to OPL-0401 Dose 1 twice daily for 24 weeks
干预措施: OPL-0401 Dose 1 (Drug)
Placebo
Participants are randomized to matching Placebo twice daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
时间窗: 24 weeks/168 days
Proportion of patients with a ≥2-step improvement from baseline in DRSS
次要结局
- Proportion of patients with an improvement or worsening in DRSS(12 Weeks/84 days and 24 Weeks/168 days)
- Safety and tolerability(198 days)