Phase 2a Open Label Study to Assess the Efficacy and Safety of Subcutaneous 15mg AKB-9778 Administered Twice Daily for 84 Days in Subjects With Retinal Vein Occlusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Visual acuity in subjects with RVO
研究概览
简要总结
Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.
详细描述
Subjects will participate in the study for up to 168 days. Up to 20 subjects will be enrolled in the study.
Subjects will self-administer study medication as subcutaneous (SC) injections in the abdomen (preferably) twice per day; the first dose each day should be administered in the morning and the evening dose should be administered within 8 to 16 hours after the morning dose.
Safety assessments will be conducted at each study visit during treatment and AEs will be collected throughout the Treatment period and during the 56-days observation period visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite retinal thickening due to RVO involving the central macula based on Investigator's clinical evaluation and demonstrated by sdOCT.
- •Mean central subfield thickness of at least 300 µm by sdOCT with presence of intraretinal fluid
- •ETDRS BCVA letter score ≤ 76 and ≥
- •Decrease in vision determined to be primarily the result of macular dema due to RVO and not due to other causes.
- •The following is a abbreviated list of
排除标准
- •Macular edema is considered to be due to a cause other than RVO
- •Any other ocular disease that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), retinal inflammatory, infectious disease, or primary open-angle glaucoma.
- •High myopia (-8 diopter or more correction).
- •History of idiopathic or autoimmune uveitis.
- •History of any ocular surgery within 3 months prior to Day
- •History of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day
- •History of prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1 (e.g., triamcinolone).
- •History of prior treatment with intravitreal anti-VEGF treatment within 16 weeks prior to Day 1.
研究组 & 干预措施
15 mg AKB-9778 BID for 84 days
Subcutaneous AKB-9778 15 mg BID (total dose of 30 mg/day) for 84 days
干预措施: AKB-9778 (Drug)
结局指标
主要结局
Visual acuity in subjects with RVO
时间窗: 84 days
Best corrected visual acuity is measured by ETDRS charts
次要结局
未报告次要终点