A Phase 2, Double-masked, Randomized, Sham-controlled, Multiple-dose Study of the Efficacy and Safety of Intravitreal KUS121 in the Treatment of Non-Arteritic Central Retinal Artery Occlusion (CRAO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 11
- 主要终点
- Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 12 compared to baseline
研究概览
简要总结
Central retinal artery occlusion (CRAO) is an ophthalmologic emergency which leads to severe and permanent vision loss. There is no evidence-based therapy for CRAO. The objective of this GION study is to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in participants with acute non-arteritic CRAO.
详细描述
This is a Phase II, double-masked, sham-controlled, multi-center, parallel-group study to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in patients with non-arteritic Central Retinal Artery Occlusion (CRAO) diagnosed and treated within 3-48 hours of disease onset. Participants will be randomized to high dose KUS121, low dose KUS121, or sham in a 1:1:1 ratio. Participants will receive daily intravitreal injections of KUS 121 or sham, which mimics an injection, from Day 1 through Day 3. Primary efficacy endpoint is the proportion of participants who gain 15 letters or more in BCVA compared with baseline and will be assessed at Week 12. Safety evaluation will continue until a 12-month follow up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are willing and able to comply with clinic visits and study-related procedures and able to provide signed informed consent in person or from their legally authorized representative
- •Males and females ≥ 20 years of age at that time of providing signed informed consent
- •Diagnosed as non-arteritic Central Retinal Artery Occlusion from 3 hours until no more than 48 hours after the onset of significant visual acuity changes
- •Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 0 to 35 in the study eye at screening prior to enrollment (eyes with 'no light perception' or 'light perception' are to be excluded)
- •Retinal thickening or hyper-reflectivity in retinal inner layers in spectral domain optical coherence tomography (SD-OCT), or white turbid edema in fundus examination
排除标准
- •Presence of the following conditions in the study eye:
- •Infection in or around the eye
- •Uncontrolled intraocular pressure
- •Abnormality in macula other than CRAO findings
- •History of macular photocoagulation
- •Opacity in visual axis preventing fundus examination or fundus imaging (e.g., corneal dystrophy)
- •Neovascularization of iris and retina
- •Any inflammatory disease involving the eye
- •Optic atrophy
- •Glaucomatous cupping greater than 0.9
- •Prior vitrectomy
- •Aphakia with the absence of posterior capsule
- •Any IVT injection or sub-Tenon's injection within 1 month of screening
- •Any intraocular surgery or ocular implant within 3 months of screening
- •Any history of ocular trauma within 3 months of screening
- •Thrombolytic, fibrinolytic or prostaglandin E1 systemic treatment within 1 month of screening
- •A positive urine pregnancy test on Day 1 prior to study enrollment
- •History of allergy or hypersensitivity to KUS121 or a compound with a condensed polycyclic aromatic hydrocarbon skeleton represented by naphthalene and any of excipients of KUS121 product, fluorescein, or any study treatment-related mandatory ingredients that is not amenable to treatment
- •Known hypersensitivity to a study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
- •Presence of other medical disease, physical or ocular examination finding, or clinical laboratory finding that in the opinion of the Investigator contraindicates the use of an investigational product, might interfere with the evaluation of the efficacy or safety of the study drug, may put the participant at significant risk or might interfere with the participant's ability to participate in the study
研究组 & 干预措施
KUS121 high dose group
干预措施: KUS121 high dose (Drug)
KUS121 low dose group
干预措施: KUS121 low dose (Drug)
Control group
干预措施: Sham procedure (Drug)
结局指标
主要结局
Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 12 compared to baseline
时间窗: At baseline, Week 12
BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study. A higher ETDRS letter score means a better outcome (better visual acuity).
次要结局
- Change in retinal thickness from baseline at Week 12 as measured by SD-OCT(At baseline, Week 12)
- Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 4 compared to baseline(At baseline, Week 4)
- Proportion of study eyes which achieve a gain of 0.3 Logarithm of Minimum Angle of Resolution (Log MAR) in BCVA at Week 12 compared to baseline(At baseline, Week 12)
- Proportion of study eyes which achieve a gain of 10 ETDRS letters or more in BCVA at Week 12 compared to baseline(At baseline, Week 12)
- Mean change in BCVA (readable letters and Log MAR) at Week 12 compared to baseline(At baseline, Week 12)
- Change in the area of visual field from baseline to Week 12 as measured by Humphrey Field Analyzer(At baseline, Week 12)
- Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)(From baseline through Week 48)
- Patients Reported Outcome(Up to Week 12)